Early Rehabilitation After Hand or Wrist Ambulatory Surge... | NCT04306666

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

NCT04306666

Sponsor

University Hospital, Montpellier

Status

Unknown status

Last Update Posted

Mar 13, 2020Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Hand Surgery
Wrist Surgery

Interventions

Regional anesthesia

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 30, 2019Actual

Primary Completion Date

Dec 1, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Nov 29, 2019

First Submission Date that Met QC Criteria

Mar 12, 2020

First Posted Date

Mar 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2020

Last Update Posted Date

Mar 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Walant group		Walant group	Other: Regional anesthesia
Axillary Brachial Plexus Block		Axillary Brachial Plexus Block	Other: Regional anesthesia

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regional anesthesia	Other	Injection of local anesthetics by a regional anesthesia named Walant block (Wide Awak Local anesthesia No Tourniquet)or by axillary brachial plexus block.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
maximal pain score during the first 24 hours after surgery	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion criteria:

- NA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All adults patients scheduled for hand or wrist ambulatory surgery

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
olivier CHOQUET, PhD	Contact	467338256	33	o-choquet@chu-montpellier.fr

Overall Officials

Name	Affiliation	Role
olivier CHOQUET, PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier	Recruiting	Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000765	Anesthesia, Conduction

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided