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OpenTrials
Completed

NCT Number: NCT02641613

Retroclavicular Versus Supraclavicular Brachial Plexus Block for Hand and Forearm Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hopital du Valais

Sion, 1950, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retroclavicular block

Procedure

retroclavicular block for forearm or hand surgery

Supraclavicular block

Procedure

supraclavicular block for forearm or hand surgery

Primary outcomes

  1. Success rate (loss of sensation to pinprick in the forearm and hand)

    Time frame: 30 minutes after the injection

Secondary outcomes

  1. Needling time in seconds

    Time frame: 15 min

  2. Time to first analgesic request

    Time frame: 24 hours

  3. Block-related complications

    Time frame: 24 hours

  4. Postoperative opioid consumption on postoperative day 1

    Time frame: 24 hours

  5. Pain scores at 12 hours postoperatively

    Time frame: 12 hours

    measured on a visual analogue scale between 0 and 100

  6. Pain scores on postoperative day 1

    Time frame: 24 hours

    measured on a visual analogue scale between 0 and 100

  7. 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)

Sponsors and collaborators

Lead sponsor

Hôpital du Valais

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2015
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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