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A Comparison of Ropivacaine Alone Versus Combination of Dexamethasone and Clonidine for Block

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ClinicalTrials.gov Identifier: NCT02151487
Recruitment Status : Completed
First Posted : May 30, 2014
Results First Posted : July 3, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Dawood Nasir, University of Texas Southwestern Medical Center

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Upper Extremity Surgery
Interventions Drug: Ropivacaine
Drug: Ropivacaine and dexamethasone
Drug: Ropivacaine and clonidine
Drug: Ropivacaine, dexamethasone and clonidine
Enrollment 97
Recruitment Details  
Pre-assignment Details Study takes place in routine clinical context. Subjects who received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants enrolled to the study.
Arm/Group Title Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine
Hide Arm/Group Description

Ropivacaine 0.5% 25 ml alone for supraclavicular block

Ropivacaine: Ropivacaine alone

25 ml 0.5% ropivacaine + 4 mg dexamethasone

Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone

25 ml 0.5% ropivacaine + 100 mcg clonidine

Ropivacaine and clonidine: Ropivacaine combination with clonidine

25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine

Period Title: Overall Study
Started 27 27 20 23
Completed 25 22 16 20
Not Completed 2 5 4 3
Arm/Group Title Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine Total
Hide Arm/Group Description

Ropivacaine 0.5% 25 ml alone for supraclavicular block

Ropivacaine: Ropivacaine alone

25 ml 0.5% ropivacaine + 4 mg dexamethasone

Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone

25 ml 0.5% ropivacaine + 100 mcg clonidine

Ropivacaine and clonidine: Ropivacaine combination with clonidine

25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine

Total of all reporting groups
Overall Number of Baseline Participants 27 27 20 23 97
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 22 participants 16 participants 20 participants 83 participants
49  (16) 43  (14) 48  (11) 50  (11) 48  (13)
[1]
Measure Analysis Population Description: Participants were ambulatory cases and followed with 24 h phone call visit. Due to follow-up lost, analysis population is lower than overall population.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 22 participants 16 participants 20 participants 83 participants
Female
10
  40.0%
13
  59.1%
8
  50.0%
10
  50.0%
41
  49.4%
Male
15
  60.0%
9
  40.9%
8
  50.0%
10
  50.0%
42
  50.6%
[1]
Measure Analysis Population Description: Subjects were ambulatory surgery cases and followed via phone call visit 24 hours after discharge.
1.Primary Outcome
Title Duration of the Sensorial Supraclavicular Block
Hide Description Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home
Time Frame within 24-hr after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Participants received supraclavicular nerve block with ropivacaine alone and ropivacaine with adjuvants.
Arm/Group Title Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine
Hide Arm/Group Description:

Ropivacaine 0.5% 25 ml alone for supraclavicular block

Ropivacaine: Ropivacaine alone

25 ml 0.5% ropivacaine + 4 mg dexamethasone

Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone

25 ml 0.5% ropivacaine + 100 mcg clonidine

Ropivacaine and clonidine: Ropivacaine combination with clonidine

25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine

Overall Number of Participants Analyzed 25 22 16 20
Mean (Standard Deviation)
Unit of Measure: hour
13.4  (6) 14  (6.6) 17.4  (6) 18.8  (6.2)
2.Secondary Outcome
Title Postoperative Analgesia
Hide Description Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain).
Time Frame within 15 minutes at postanesthesia care unit (PACU) arrival
Hide Outcome Measure Data
Hide Analysis Population Description
Patients received supraclavicular nerve block with ropivacaine alone or ropivacaine with adjuvants. Postoperative pain was evaluated by using Visual Analog Pain Scores on the scale of 10 (0=no pain and 10-worse pain).
Arm/Group Title Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine
Hide Arm/Group Description:

Ropivacaine 0.5% 25 ml alone for supraclavicular block

Ropivacaine: Ropivacaine alone

25 ml 0.5% ropivacaine + 4 mg dexamethasone

Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone

25 ml 0.5% ropivacaine + 100 mcg clonidine

Ropivacaine and clonidine: Ropivacaine combination with clonidine

25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine

Overall Number of Participants Analyzed 25 22 16 20
Median (Inter-Quartile Range)
Unit of Measure: score on a scale of 10
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Time Frame Following nerve block to postoperative 24 hour period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine
Hide Arm/Group Description

Ropivacaine 0.5% 25 ml alone for supraclavicular block

Ropivacaine: Ropivacaine alone

25 ml 0.5% ropivacaine + 4 mg dexamethasone

Ropivacaine and dexamethasone: Ropivacaine combination with dexamethasone

25 ml 0.5% ropivacaine + 100 mcg clonidine

Ropivacaine and clonidine: Ropivacaine combination with clonidine

25 ml 0.5% ropivacaine + 4 mg dexamethasone + 100 mcg clonidine

Ropivacaine, dexamethasone and clonidine: Ropivacaine combination with dexamethasone and clonidine

All-Cause Mortality
Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/27 (0.00%)      0/20 (0.00%)      0/23 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/27 (0.00%)      0/20 (0.00%)      0/23 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ropivacaine Ropivacaine and Dexamethasone Ropivacaine and Clonidine Ropivacaine, Dexamethasone and Clonidine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      1/27 (3.70%)      0/20 (0.00%)      0/23 (0.00%)    
Respiratory, thoracic and mediastinal disorders         
Shortness of breath (SOB)  1 [1]  0/27 (0.00%)  0 1/27 (3.70%)  1 0/20 (0.00%)  0 0/23 (0.00%)  0
1
Term from vocabulary, Shorness of breath
Indicates events were collected by systematic assessment
[1]
Shortness of breath immediately after nerve block
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dawood Nasir
Organization: UT Southwestern Medical Center
Phone: 214-590-5352
EMail: Dawood.Nasir@UTSouthwestern.edu
Layout table for additonal information
Responsible Party: Dawood Nasir, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT02151487     History of Changes
Other Study ID Numbers: 102013-068
First Submitted: May 28, 2014
First Posted: May 30, 2014
Results First Submitted: April 20, 2018
Results First Posted: July 3, 2019
Last Update Posted: July 3, 2019