ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Plain Ropiviciane

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

Ropiviciane + Buprenorphine

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

Ropivicaine + Clonidine

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

Ropiviciane + Dexamethasone

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


Participant Flow:   Overall Study
    Plain Ropiviciane   Ropiviciane + Buprenorphine   Ropivicaine + Clonidine   Ropiviciane + Dexamethasone
STARTED   40   40   40   40 
COMPLETED   40   40   40   40 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Plain Ropivacaine

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

Ropivacaine + Buprenorphine

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

Ropivacaine + Clonidine

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

Ropivacaine + Dexamethasone

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 Total of all reporting groups

Baseline Measures
   Plain Ropivacaine   Ropivacaine + Buprenorphine   Ropivacaine + Clonidine   Ropivacaine + Dexamethasone   Total 
Overall Participants Analyzed 
[Units: Participants]
 40   40   40   40   160 
Age 
[Units: Participants]
Count of Participants
         
Participants Analyzed   40   40   40   40   160 
<=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 
[Units: Years]
Mean (Standard Deviation)
         
Participants Analyzed   40   40   40   40   160 
   45.38  (14.39)   44.8  (14.2)   43.1  (14.74)   42.3  (13.71)   43.89  (14.19) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Participants Analyzed   40   40   40   40   160 
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] 
[Units: Participants]
Count of Participants
         
Participants Analyzed   0   0   0   0   0 
               0 
[1] Race and Ethnicity were not collected from any participant.
ASA (American Society of Anesthesiolgy) Classification system [1] 
[Units: Participants]
Count of Participants
         
ASA classification I           
Participants Analyzed   40   40   40   40   160 
ASA classification I   13   14   15   17   59 
ASA classification II           
Participants Analyzed   40   40   40   40   160 
ASA classification II   23   24   18   21   86 
ASA classification III           
Participants Analyzed   40   40   40   40   160 
ASA classification III   4   2   7   2   15 
[1] I-a normal healthy patient II- a patient with mild systemic disease III-a patient with severe systemic disease
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
         
Participants Analyzed   40   40   40   40   160 
   98.82  (22.71)   98.13  (21.47)   99.78  (25.95)   95.63  (21.41)   98.09  (22.79) 


  Outcome Measures

1.  Primary:   Duration of Analgesia   [ Time Frame: 1-3 days post-operative ]

2.  Secondary:   Block Set up Time   [ Time Frame: Day one ]

3.  Secondary:   Sensory Duration of Block   [ Time Frame: Day 1-3 ]

4.  Secondary:   Patient Reporting Vomiting at Home   [ Time Frame: 1-3 days ]

5.  Secondary:   Number of Patients Vomiting in the PACU (Post-Anesthesia Care Unit)   [ Time Frame: Post-op Day 0 (Baseline) ]

6.  Secondary:   Number of Patients Reporting Nausea at Home   [ Time Frame: 1-3 days ]

7.  Secondary:   Number of Patients Reporting Nausea in the PACU   [ Time Frame: Post-op day 0 (Baseline) ]

8.  Secondary:   Motor Duration of Block   [ Time Frame: Day 1-3 ]

9.  Secondary:   Number of Patients With Blood Pressure (BP) Changes in the PACU   [ Time Frame: Post-op Day 0 (baseline) ]

10.  Secondary:   Number of Patient With Blood Pressure Changes in the Second Stage Recovery Area   [ Time Frame: Post-op Day 0 (baseline) ]

11.  Secondary:   Pain Score Reported by Patients at First Phone Call   [ Time Frame: Day 1-3 ]

12.  Secondary:   Number of Patients Reporting Itching in the PACU   [ Time Frame: Post-op day 0 (baseline) ]

13.  Secondary:   Number of Patients Reporting Itching at Home   [ Time Frame: 1-3 days ]

14.  Other Pre-specified:   Surgical Position   [ Time Frame: Post-op Day 0 (Baseline) ]

15.  Other Pre-specified:   Surgical Length   [ Time Frame: Post op Day 0 (Baseline) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: melinda-seering@uiowa.edu


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