Clinical Trial: Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Hôpital du Valais

Current Primary Outcome: Success rate (loss of sensation to pinprick in the forearm and hand) [ Time Frame: 30 minutes after the injection ]

Original Primary Outcome: Loss of sensation to pinprick in the forearm and hand [ Time Frame: 30 minutes ]

measured on a scale


Current Secondary Outcome:

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


Original Secondary Outcome:

  • Needle time in seconds [ Time Frame: 30 min ]
    seconds from insertion of needle to completen of anaesthetic injection
  • Time to first analgesic request [ Time Frame: 4 hours ]
  • Block-related complications [ Time Frame: 24 hours ]
  • postoperative morphine consumption [ Time Frame: 24 hours ]
  • Pain scores at 12 hours postoperatively [ Time Frame: 12 hours ]
    measured on a visual analogue scale between 0 and 100
  • Pain scores at 24 hours postoperatively [ Time Frame: 24 hours ]
    measured on a visual analogue scale between 0 and 100
  • Number of block failures [ Time Frame: 30 min ]
  • Patient satisfaction as assessed by numerical rating scale [ Time Frame: 24 hours ]
    Patient satisfaction on a scale between 0 (= completely dissatisfied) and 10 (= completely satisfied)


Information By: Hôpital du Valais

Dates:
Date Received: December 1, 2015
Date Started: January 2016
Date Completion: December 2017
Last Updated: August 31, 2016
Last Verified: August 2016