Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery

Study Overview
=================
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.

Official Title
-----------------
The Efficacy of Retroclavicular Versus Supraclavicular Brachial Plexus Block in Patients Undergoing Forearm and Hand Surgery: a Randomized Controlled Double-blinded Trial.

Conditions
-----------------
Hand Injury

Intervention / Treatment
-----------------
* Procedure: retroclavicular block
* Procedure: supraclavicular block


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: supraclavicular<br>patients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 % | Procedure: supraclavicular block<br>* supraclavicular block for forearm or hand surgery<br>|
| Experimental: retroclavicular block<br>patients receive a retroclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 % | Procedure: retroclavicular block<br>* retroclavicular block for forearm or hand surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate (loss of sensation to pinprick in the forearm and hand) |  | 30 minutes after the injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needling time in seconds |  | 15 min | 
| Time to first analgesic request |  | 24 hours | 
| Block-related complications |  | 24 hours | 
| Postoperative opioid consumption on postoperative day 1 |  | 24 hours | 
| Pain scores at 12 hours postoperatively | measured on a visual analogue scale between 0 and 100 | 12 hours | 
| Pain scores on postoperative day 1 | measured on a visual analogue scale between 0 and 100 | 24 hours | 
| Patient satisfaction as assessed by numerical rating scale | Patient satisfaction on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied) | 24 hours |