Clinical trial NCT02641613: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Injury
Lead sponsor: Hôpital du Valais
Sponsor class: OTHER
First posted: 2015-12-29
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be randomized to one of two groups:

1. Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound;
2. 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.

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

Primary outcomes:
measure: Success rate (loss of sensation to pinprick in the forearm and hand)
timeFrame: 30 minutes after the injection
Secondary outcomes:
measure: Needling time in seconds
timeFrame: 15 min
measure: Time to first analgesic request
timeFrame: 24 hours
measure: Block-related complications
timeFrame: 24 hours
measure: Postoperative opioid consumption on postoperative day 1
timeFrame: 24 hours
measure: Pain scores at 12 hours postoperatively
timeFrame: 12 hours
measure: Pain scores on postoperative day 1
timeFrame: 24 hours
measure: Patient satisfaction as assessed by numerical rating scale
timeFrame: 24 hours
Other outcomes:
Locations:
city: Sion
country: Switzerland
facility: Hopital du Valais
Study officials:
affiliation: Hopital du Valais
name: Sina Grape, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHUV
name: Eric Albrecht, MD
role: STUDY_DIRECTOR
References:
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.