NCT02641613

Brief Summary

Patients will be randomized to one of two groups:

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2015

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

May 9, 2018

Status Verified

May 1, 2018

Enrollment Period

2.3 years

First QC Date

December 1, 2015

Last Update Submit

May 8, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

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

    30 minutes after the injection

Secondary Outcomes (7)

  • 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

    12 hours

  • +2 more secondary outcomes

Study Arms (2)

supraclavicular

ACTIVE COMPARATOR

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

retroclavicular block

EXPERIMENTAL

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

Interventions

retroclavicular block for forearm or hand surgery

retroclavicular block

supraclavicular block for forearm or hand surgery

supraclavicular

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients who undergo forearm or hand surgery under brachial plexus block.

You may not qualify if:

  • History of allergic reaction to local anaesthetics
  • Peripheral neuropathy
  • Renal or hepatic insufficiency
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital du Valais

Sion, 1950, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Sina Grape, MD

    Hopital du Valais

    PRINCIPAL INVESTIGATOR
  • Eric Albrecht, MD

    CHUV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 1, 2015

First Posted

December 29, 2015

Study Start

January 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

May 9, 2018

Record last verified: 2018-05

Locations