Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? (WalantBAX)

March 12, 2020 updated by: University Hospital, Montpellier

Early Rehabilitation After Hand or Wrist Ambulatory Surgery : How to Preserve Locomotion at Home Without Rebound Pain? Study Walant " Wide Awake Local Anesthesia No Tourniquet " Versus Axillary Brachial Plexus Block.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

data will be collected on patient records and will be compared between groups of regional anesthesia.

Data will be :

  • time to first analgesic request
  • sensory block
  • rescue analgesia during the first 24 hours after surgery
  • maximal pain score during the first 24 hours after surgery
  • patient satisfaction of managing care

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults patients scheduled for hand or wrist ambulatory surgery

Description

Inclusion Criteria:

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

Exclusion criteria:

- NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Walant group
Other: Regional anesthesia
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 Block
Other: Regional anesthesia
Injection of local anesthetics by a regional anesthesia named Walant block (Wide Awak Local anesthesia No Tourniquet)or by axillary brachial plexus block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of analgesia
Time Frame: 24 hours
time to first rescue analgesic request (opioid)
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maximal pain score during the first 24 hours after surgery
Time Frame: 24 hours
Pain assessments during first 24 hours : maximal pain score during the first 24 hours after surgery
24 hours
total rescue analgesia amounts the first 24 hours after surgery
Time Frame: 24 hours
Pain assessments during first 24 hours : total rescue analgesia amounts the first 24 hours after surgery
24 hours
duration of sensory block
Time Frame: 24 hours
Pain assessments during first 24 hours : duration of sensory block
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Study Director: olivier CHOQUET, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 30, 2019

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

November 29, 2019

First Submitted That Met QC Criteria

March 12, 2020

First Posted (ACTUAL)

March 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2020

Last Update Submitted That Met QC Criteria

March 12, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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