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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT04306666

Collaborator

(none)

Enrollment

Location

12.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hand Surgery Wrist Surgery	Other: Regional anesthesia

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

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.

Actual Study Start Date :

Dec 30, 2019

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Walant group 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 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.

Arm

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.

Outcome Measures

Primary Outcome Measures

duration of analgesia [24 hours]
time to first rescue analgesic request (opioid)

Secondary Outcome Measures

maximal pain score during the first 24 hours after surgery [24 hours]
Pain assessments during first 24 hours : maximal pain score during the first 24 hours after surgery
total rescue analgesia amounts the first 24 hours after surgery [24 hours]
Pain assessments during first 24 hours : total rescue analgesia amounts the first 24 hours after surgery
duration of sensory block [24 hours]
Pain assessments during first 24 hours : duration of sensory block

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT04306666

Other Study ID Numbers:

RECHMPL19_0429

First Posted:

Mar 13, 2020

Last Update Posted:

Mar 13, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Regional anesthesia

Walant block

Additional relevant MeSH terms:

Anesthetics

Study Results

No Results Posted as of Mar 13, 2020