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Analgesia Duration of Dexamethasone, Buprenorphine, or Clonidine With Ropivacaine for Interscalene Nerve Block

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ClinicalTrials.gov Identifier: NCT03117140
Recruitment Status : Completed
First Posted : April 17, 2017
Results First Posted : July 3, 2018
Last Update Posted : July 3, 2018
Sponsor:
Information provided by (Responsible Party):
Melinda Seering, University of Iowa

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Anesthesia, Local
Interventions Drug: Ropivacaine 0.75%
Drug: Ropivacaine 0.75% + 300 mcg Buprenorphine
Drug: Ropivacaine 0.75% + 75 mcg clonidine
Drug: Ropivacaine 0.75% + 8 mg dexamethasone
Enrollment 160

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Plain Ropiviciane Ropiviciane + Buprenorphine Ropivicaine + Clonidine Ropiviciane + Dexamethasone
Hide Arm/Group Description

Plain Ropivicaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivicaine 0.75%: Only ropivicaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivicaine 0.75% + 300 mcg Buprenorphine: Ropivicaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivicaine 0.75% + 75 mcg clonidine: Ropivicaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivicaine 0.75% + 8 mg dexamethasone: Ropivicaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block

Period Title: Overall Study
Started 40 40 40 40
Completed 40 40 40 40
Not Completed 0 0 0 0
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone Total
Hide Arm/Group Description

Plain ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Total of all reporting groups
Overall Number of Baseline Participants 40 40 40 40 160
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
37
  92.5%
38
  95.0%
39
  97.5%
40
 100.0%
154
  96.3%
>=65 years
3
   7.5%
2
   5.0%
1
   2.5%
0
   0.0%
6
   3.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
45.38  (14.39) 44.8  (14.2) 43.1  (14.74) 42.3  (13.71) 43.89  (14.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
Female
15
  37.5%
9
  22.5%
7
  17.5%
9
  22.5%
40
  25.0%
Male
25
  62.5%
31
  77.5%
33
  82.5%
31
  77.5%
120
  75.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
ASA (American Society of Anesthesiolgy) Classification system   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
ASA classification I Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
13
  32.5%
14
  35.0%
15
  37.5%
17
  42.5%
59
  36.9%
ASA classification II Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
23
  57.5%
24
  60.0%
18
  45.0%
21
  52.5%
86
  53.8%
ASA classification III Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
4
  10.0%
2
   5.0%
7
  17.5%
2
   5.0%
15
   9.4%
[1]
Measure Description: I-a normal healthy patient II- a patient with mild systemic disease III-a patient with severe systemic disease
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilograms
Number Analyzed 40 participants 40 participants 40 participants 40 participants 160 participants
98.82  (22.71) 98.13  (21.47) 99.78  (25.95) 95.63  (21.41) 98.09  (22.79)
1.Primary Outcome
Title Duration of Analgesia
Hide Description Patients are called 1-3 days post-operatively to assess when the analgesia of their nerve block wore off
Time Frame 1-3 days post-operative
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: minutes
911
(652 to 1300)
1026.5
(756.5 to 1392.5)
1181
(880.5 to 1528.5)
982
(799 to 1270)
2.Secondary Outcome
Title Block Set up Time
Hide Description Patients are assessed from needle removal to when they are no longer able to feel cold on the blocked extremity
Time Frame Day one
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg Buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: minutes
6
(3 to 9)
3
(3 to 6)
6
(3 to 6)
4.5
(3 to 10.5)
3.Secondary Outcome
Title Sensory Duration of Block
Hide Description Patients are called 1-3 days post-operatively to assess when the sensory component of their nerve block wore off
Time Frame Day 1-3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: minutes
923.5
(652 to 1304)
982
(705 to 1189)
940.5
(736.5 to 1234)
1066
(797 to 1240)
4.Secondary Outcome
Title Patient Reporting Vomiting at Home
Hide Description Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Time Frame 1-3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about vomiting at home and therefore was not included in the analysis
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 39 39 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
3
   7.7%
2
   5.0%
1
   2.5%
5.Secondary Outcome
Title Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)
Hide Description Vomiting in PACU (Post-Anesthesia Care Unit) for patients was looked at
Time Frame Post-op Day 0 (Baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
   2.5%
0
   0.0%
0
   0.0%
6.Secondary Outcome
Title Number of Patients Reporting Nausea at Home
Hide Description Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Time Frame 1-3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient in the Plain Ropivacaine group and the Ropivacaine and Buprenorphine group did not complete the survey about nausea at home and therefore was not included in the analysis
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 39 39 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.3%
9
  23.1%
2
   5.0%
3
   7.5%
7.Secondary Outcome
Title Number of Patients Reporting Nausea in the PACU
Hide Description PACU (Post-Anesthesia Care Unit) assessment of nausea
Time Frame Post-op day 0 (Baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
4
  10.0%
9
  22.5%
2
   5.0%
9
  22.5%
8.Secondary Outcome
Title Motor Duration of Block
Hide Description Patients are called 1-3 days post-operatively to assess when motor component of their nerve block wore off
Time Frame Day 1-3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivicaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: minutes
1120
(748 to 1484)
1198
(835 to 1406)
1090
(829 to 1526)
1143.5
(949.5 to 1356.5)
9.Secondary Outcome
Title Number of Patients With Blood Pressure (BP) Changes in the PACU
Hide Description Blood pressure changes in PACU (Post-Anesthesia Care Unit) for patients was looked at
Time Frame Post-op Day 0 (baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient in Ropivacaine and Buprenorphine group did get data for the BP changes in the PACU for the study so therefore was not included in the analysis
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 39 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
8
  20.0%
3
   7.7%
7
  17.5%
2
   5.0%
10.Secondary Outcome
Title Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area
Hide Description Blood pressure changes in Second Stage Recovery Area for patients was looked at
Time Frame Post-op Day 0 (baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient in Ropivacaine and Buprenorphine group did not have blood pressure data obtained in the second stage area so therefore was not included in the analysis
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 39 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
5
  12.5%
1
   2.6%
5
  12.5%
0
   0.0%
11.Secondary Outcome
Title Pain Score Reported by Patients at First Phone Call
Hide Description Patients are called 1-3 days post-operatively to assess pain. Pain score is 0-10 scale with 0 is no pain and 10 is most severe pain.
Time Frame Day 1-3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4
(3 to 5)
3
(2 to 5)
4
(2 to 5.5)
3
(2 to 4.5)
12.Secondary Outcome
Title Number of Patients Reporting Itching in the PACU
Hide Description Patients itching was assessed post-op in the PACU.
Time Frame Post-op day 0 (baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 patient in the Ropivacaine and Buprenorphine group did not obtain data on the itching in the PACU therefore was not included in the analysis
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 39 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
5
  12.5%
2
   5.1%
6
  15.0%
3
   7.5%
13.Secondary Outcome
Title Number of Patients Reporting Itching at Home
Hide Description Patients are called 1-3 days post-operatively to assess if they had any side effects of the adjuvants such as nausea, vomiting or itching. There blood pressure is looked at pre-op and compared to post-op. Any prolonged PACU (Post Anesthesia Care Unit) stay for sedation is recorded.
Time Frame 1-3 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.5%
2
   5.0%
2
   5.0%
0
   0.0%
14.Other Pre-specified Outcome
Title Surgical Position
Hide Description Surgical position was recorded
Time Frame Post-op Day 0 (Baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Measure Type: Count of Participants
Unit of Measure: Participants
Beach Chair
38
  95.0%
31
  77.5%
31
  77.5%
32
  80.0%
Lateral
2
   5.0%
6
  15.0%
7
  17.5%
6
  15.0%
Supine
0
   0.0%
3
   7.5%
2
   5.0%
2
   5.0%
15.Other Pre-specified Outcome
Title Surgical Length
Hide Description Surgical length was recorded
Time Frame Post op Day 0 (Baseline)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description:

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

Overall Number of Participants Analyzed 40 40 40 40
Median (Inter-Quartile Range)
Unit of Measure: minutes
68.5
(45 to 94)
65
(49 to 87.5)
73.5
(56 to 101)
71
(47.5 to 117)
Time Frame The adverse advents data was collected from Day 1 until Day 3 when the phone call was made. We do have a post-block clinic where patients with adverse events post-block are seen. None from the study were seen here.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Hide Arm/Group Description

Plain Ropivacaine 0.75%, (225 mg) total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75%: Only ropivacaine 0.75% is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 300 mcg buprenorphine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 300 mcg buprenorphine: Ropivacaine 0.75% + 300 mcg buprenorphine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with 75 mcg clonidine, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 75 mcg clonidine: Ropivacaine 0.75% + 75 mcg clonidine is administered for this arm of the interscalene block

A mixture of 0.75% ropivacaine with and 8 mg dexamethasone, total volume 32 cc for interscalene block given pre-operatively

Ropivacaine 0.75% + 8 mg dexamethasone: Ropivacaine 0.75% + 8 mg dexamethasone is administered for this arm of the interscalene block

All-Cause Mortality
Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Plain Ropivacaine Ropivacaine + Buprenorphine Ropivacaine + Clonidine Ropivacaine + Dexamethasone
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%)   0/40 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Melinda Seering
Organization: Univesity of Iowa Hospitals and Clinics
Phone: 3193561616
Publications:
Responsible Party: Melinda Seering, University of Iowa
ClinicalTrials.gov Identifier: NCT03117140     History of Changes
Other Study ID Numbers: 201304727
First Submitted: April 11, 2017
First Posted: April 17, 2017
Results First Submitted: April 17, 2018
Results First Posted: July 3, 2018
Last Update Posted: July 3, 2018