Back to resultsRetroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery
Primary Purpose
Hand Injury
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
retroclavicular block
supraclavicular block
Sponsored by
About this trial
This is an interventional treatment trial for Hand Injury
Eligibility Criteria
Inclusion Criteria:
- Adult patients who undergo forearm or hand surgery under brachial plexus block.
Exclusion Criteria:
History of allergic reaction to local anaesthetics
- Peripheral neuropathy
- Renal or hepatic insufficiency
- Coagulation disorders
Sites / Locations
- Hopital du Valais
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
supraclavicular
retroclavicular block
Arm Description
patients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %
patients receive a retroclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %
Outcomes
Primary Outcome Measures
Success rate (loss of sensation to pinprick in the forearm and hand)
Secondary Outcome Measures
Needling time in seconds
Time to first analgesic request
Block-related complications
Postoperative opioid consumption on postoperative day 1
Pain scores at 12 hours postoperatively
measured on a visual analogue scale between 0 and 100
Pain scores on postoperative day 1
measured on a visual analogue scale between 0 and 100
Patient satisfaction as assessed by numerical rating scale
Patient satisfaction on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02641613
Brief Title
Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery
Official Title
The Efficacy of Retroclavicular Versus Supraclavicular Brachial Plexus Block in Patients Undergoing Forearm and Hand Surgery: a Randomized Controlled Double-blinded Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital du Valais
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Patients will be randomized to one of two groups:
Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound;
Retroclavicular group: retroclavicular brachial plexus block performed with the aid of ultrasound.
Detailed Description
The study will be proposed to all patients undergoing formarm or hand surgery under brachial plexus block. Patients will be randomized to one of two groups The first group - supraclavicular group - will receive an ultrasound-guided brachial plexus block via the supraclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The second group - retroclavicular group - will receive an ultrasound-guided brachial plexus block via the retroclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. Primary outcome is success rate at 30 minutes after the injection defined as loss of sensation to pinprick in the forearm and hand. Secondary outcomes are: needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
supraclavicular
Arm Type
Active Comparator
Arm Description
patients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %
Arm Title
retroclavicular block
Arm Type
Experimental
Arm Description
patients receive a retroclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %
Intervention Type
Procedure
Intervention Name(s)
retroclavicular block
Intervention Description
retroclavicular block for forearm or hand surgery
Intervention Type
Procedure
Intervention Name(s)
supraclavicular block
Intervention Description
supraclavicular block for forearm or hand surgery
Primary Outcome Measure Information:
Title
Success rate (loss of sensation to pinprick in the forearm and hand)
Time Frame
30 minutes after the injection
Secondary Outcome Measure Information:
Title
Needling time in seconds
Time Frame
15 min
Title
Time to first analgesic request
Time Frame
24 hours
Title
Block-related complications
Time Frame
24 hours
Title
Postoperative opioid consumption on postoperative day 1
Time Frame
24 hours
Title
Pain scores at 12 hours postoperatively
Description
measured on a visual analogue scale between 0 and 100
Time Frame
12 hours
Title
Pain scores on postoperative day 1
Description
measured on a visual analogue scale between 0 and 100
Time Frame
24 hours
Title
Patient satisfaction as assessed by numerical rating scale
Description
Patient satisfaction on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients who undergo forearm or hand surgery under brachial plexus block.
Exclusion Criteria:
History of allergic reaction to local anaesthetics
Peripheral neuropathy
Renal or hepatic insufficiency
Coagulation disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sina Grape, MD
Organizational Affiliation
Hopital du Valais
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric Albrecht, MD
Organizational Affiliation
CHUV
Official's Role
Study Director
Facility Information:
Facility Name
Hopital du Valais
City
Sion
ZIP/Postal Code
1950
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30857608
Citation
Grape S, Pawa A, Weber E, Albrecht E. Retroclavicular vs supraclavicular brachial plexus block for distal upper limb surgery: a randomised, controlled, single-blinded trial. Br J Anaesth. 2019 Apr;122(4):518-524. doi: 10.1016/j.bja.2018.12.022. Epub 2019 Jan 31.
Results Reference
derived
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Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery
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