NCT04306666

Brief Summary

The purpose of this retrospective study is to compare the analgesic efficacy of Walant " Wide Awake Local Anesthesia No Tourniquet " with lidocaine and bupivacaine versus axillary brachial plexus block using mepivacaïne, both performed by anesthesiologists, after hand or wrist ambulatory surgery. The main objective is to prove that Walant block improve pain relief at home measuring time to first analgesic request. The secondary objectives are to compare maximal pain, consumption of supplementary analgesics, and the duratin of sensory block between groups.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 29, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

December 30, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 13, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 13, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

November 29, 2019

Last Update Submit

March 12, 2020

Conditions

Hand SurgeryWrist Surgery

Keywords

Regional anesthesiaWalant block

Outcome Measures

Primary Outcomes (1)

  • duration of analgesia

    time to first rescue analgesic request (opioid)

    24 hours

Secondary Outcomes (3)

  • maximal pain score during the first 24 hours after surgery

    24 hours

  • total rescue analgesia amounts the first 24 hours after surgery

    24 hours

  • duration of sensory block

    24 hours

Study Arms (2)

Walant group

Walant group

Other: Regional anesthesia

Axillary Brachial Plexus Block

Axillary Brachial Plexus Block

Other: Regional anesthesia

Interventions

Regional anesthesiaOTHER

Injection of local anesthetics by a regional anesthesia named Walant block (Wide Awak Local anesthesia No Tourniquet)or by axillary brachial plexus block.

Axillary Brachial Plexus BlockWalant group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adults patients scheduled for hand or wrist ambulatory surgery

You may qualify if:

  • \- All adults patients scheduled for hand or wrist ambulatory surgery since 2016

You may not qualify if:

  • \- NA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Interventions

Anesthesia, Conduction

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • olivier CHOQUET, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

olivier CHOQUET, PhD

CONTACT

467338256o-choquet@chu-montpellier.fr

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2019

First Posted

March 13, 2020

Study Start

December 30, 2019

Primary Completion

December 1, 2020

Study Completion

December 31, 2020

Last Updated

March 13, 2020

Record last verified: 2020-03

Locations

FR(1)