A Phase 4 interventional study of Multiple injection local anesthetic and Single injection local anesthetic in Upper Extremity, sponsored by Hôpital du Valais. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-11.
Sponsored by Hôpital du Valais · Phase 4, Interventional, and Treatment
Patients will be randomized to one of two groups:
The study will be proposed to all patients undergoing formarm or hand surgery under axillary brachial plexus block. Patients will be randomized to one of two groups The first group - multiple injection group - will receive an ultrasound-guided axillary brachial plexus block with the traditional technique, i.e. multiple injections of local anesthetic in proximity to the 4 nerfs that innervate the arm. The arm will be abducted during the block procedure.
The second group - single injection group - will receive an ultrasound-guided axillary brachial plexus block with the arm placed behind the head and the elbow flexed. In this position the different nerfs group around the axillary artery where they will be blocked with a single injection of local anesthetic.
All patients will receive the same type and amount of local anesthetic: 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %.
The primary outcome measure is the time needed for the performance of the block. Secondary outcomes are: success rate of the block at 30 minutes after the injection, needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction. These outcomes are further defined in the section below.
Exclusion Criteria:
Ultrasound guided axillary plexus block with multiple injections of local anesthetic
Drug: Multiple injection local anesthetic
Ultrasound guided axillary plexus block with a single injection of local anesthetic
Drug: Single injection local anesthetic
Multiple injection local anesthetic
Single injection local anesthetic
Performance time
Time in minutes from ultrasound probe placement to end of local anesthetic injection
Time frame: 10 minutes
Needling time
Time in seconds to complete the block
Time frame: 15 minutes
Time to first analgesic request
Time in minutes to first analgesic request postoperatively
Time frame: 24 hours
Block-related complications
Infection, bleeding, neurological problems, pain during the 24 postoperative hours
Time frame: 24 hours
Postoperative opioid consumption on postoperative day 1
intravenous morphine equivalent consumption during the 24 postoperative hours
Time frame: 24 hours
Pain scores at 12 hours postoperatively
Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)
Time frame: 12 hours
Pain scores on postoperative day 1
Measured on a visual analogue scale between 0 and 10 (0 = no pain, 10 = worst pain imaginable)
Time frame: 24 hours
Patient satisfaction
Assessed by numerical rating scale on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)
Time frame: 24 hours
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hôpital du Valais