NCT04046744

Brief Summary

Fractures of the forearm bones that occur around the wrist are common in the elderly. Standard anesthesia for its surgical treatment is regional anesthesia (RA): supraclavicular block, infraclavicular block or axillary block (BAX). However, these techniques have some limitations, such as the postoperative pain management and the non-specificity of the analgesia. Indeed analgesia is not specific to the wrist and extends to the elbow and forearm, preventing rapid recovery of elbow flexion and extension when a long-acting local anesthetic (LA) is used. Recently RA techniques associating proximal anesthetic blocks with distal analgesic blocks have been proposed to serve a dual objective: good anesthesia for surgery and specific analgesia. The hypothesis of this study is that, for the wrist surgery, axillary block using a short-acting LA combined with analgesic blocks at the elbow using a long-acting LA could provide a RA installation time reduction, an optimal surgical comfort, a longer post-operative analgesia duration and a faster recovery from motor block.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

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

August 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 7, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2022

Completed
Last Updated

September 22, 2022

Status Verified

September 1, 2022

Enrollment Period

2.9 years

First QC Date

August 5, 2019

Last Update Submit

September 21, 2022

Conditions

Wrist Fracture

Keywords

Regional anesthesiaAnalgesiaUltrasound

Outcome Measures

Primary Outcomes (1)

  • Level of pain when the patient recovers the flexion of the forearm on the arm

    Pain VRS ranging from 0 to 10 (0=no pain, 10=worst possible pain)

    24 hours

Secondary Outcomes (9)

  • Duration of motor block at the elbow

    24 hours

  • Axillary block success

    40 minutes

  • Feasibility of the wrist surgery

    2 hours

  • Duration of postoperative analgesia

    72 hours

  • Postoperative morphine consumption

    48 hours

  • +4 more secondary outcomes

Study Arms (2)

BAX

ACTIVE COMPARATOR
Procedure: Axillary brachial plexus block with a long-acting local anestheticDrug: Ropivacaine

BAX-Asso

EXPERIMENTAL
Procedure: Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anestheticDrug: RopivacaineDrug: Lidocaine

Interventions

Axillary brachial plexus block with a long-acting local anestheticPROCEDURE

axillary block with 15-30 ml Ropivacaine 0,5%.

BAX
Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anestheticPROCEDURE

axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.

BAX-Asso
RopivacaineDRUG

axillary block with 15-30 ml Ropivacaine 0,5%

BAX
LidocaineDRUG

axillary block with 15-30 ml Lidocaine 1,5%

BAX-Asso

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing wrist fracture surgery under regional anesthesia
  • Consent for participation
  • Affiliation to the French social security system

You may not qualify if:

  • Chronic use of opiod analgesics
  • Chronic pain syndrome or fibromyalgia
  • Contraindication for locoregional anesthesia
  • Contraindication for opioid
  • ASA IV
  • Pregnant or breastfeeding women
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)
  • Communication difficulties or neuropsychiatric disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Clinique du Pré

Le Mans, Pays de la Loire Region, 72018, France

Location

Hôpital Privé Paul D'Egine

Champigny-sur-Marne, Île-de-France Region, 94500, France

Location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location

Hôpital Privé Armand Brillard

Nogent-sur-Marne, Île-de-France Region, 94130, France

Location

Clinique Bizet

Paris, Île-de-France Region, 75016, France

Location

Clinique Jouvenet

Paris, Île-de-France Region, 75016, France

Location

Clinique Rémusat

Paris, Île-de-France Region, 75016, France

Location

MeSH Terms

Conditions

Wrist FracturesAgnosia

Interventions

RopivacaineLidocaine

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BonePerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 6, 2019

Study Start

October 7, 2019

Primary Completion

September 1, 2022

Study Completion

September 15, 2022

Last Updated

September 22, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(7)