NCT04541745

Brief Summary

This study aims at determining if there is an association between locoregional anesthesia and postoperative functional recovery for orthopedic surgery to repair a distal radial fracture, as compared to general anesthesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

August 30, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 9, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

July 29, 2020

Last Update Submit

January 4, 2023

Conditions

Recovery of Function

Keywords

Upper limb surgeryFunctional recoveryPostoperative recoveryGeneral anesthesiaBrachial plexusNerve blockRegional anesthesiaPeripheral anesthesia

Outcome Measures

Primary Outcomes (4)

  • Functional recovery using the QuickDASH (Quick Disabilities of Arm, Shoulder and Hand) questionnaire

    The QuickDASH assess the functional recovery. It consists of 11 questions scored from 1 to 5 (1 = no difficulty to 5 = unable). Higher scores indicate a greater level of disability.

    12 weeks post-surgery

  • Functional recovery using the PRWE (Patient Rated Wrist Evaluation) Questionnaire

    The PRWE (Patient Rated Wrist Evaluation) Questionnaire assess the pain and the persistence of functional difficulty in activities of daily living following wrist surgery. It consists of 15 questions, each rated on a scale from 0 to 10. Five questions deal specifically with pain and are rated as 0 (no pain) to 10 (worse pain); 10 questions are on functional recovery, rated from 0 (no difficulty) to 10 (unable to do). Higher scores on the subscales represent greater pain or functional disability.

    12 weeks post-surgery

  • Functional recovery using the range of motion of all movement of the wrist

    We evaluate the range of motion of all movement of the wrist with a goniometer

    12 weeks post-surgery

  • Functional recovery using the grip strenght

    We evaluate the grip strength with JAMAR hydraulic hand dynamometer. The participant squeezes the device as hard as they can. We averaged three values on both sides.

    12 weeks post-surgery

Secondary Outcomes (4)

  • Pain- 2 weeks

    2 weeks post-operative

  • Pain - 6 weeks

    6 weeks post-operative

  • Functional recovery at 6 weeks

    6 weeks post-operative

  • Patient satisfaction

    2 weeks post-operative

Eligibility Criteria

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

The patient cohort will be composed of all patients undergoing orthopedic wrist surgery under locoregional or general anesthesia at the CIUSSS de l'Estrie-CHUS who meet the selection criteria.

You may qualify if:

  • years old and more
  • American Society of Anesthesiologists (ASA) score I, II, or III
  • Single distal radial fracture with or without ulna involvement
  • Orthopedic surgery by open reduction of the wrist for a distal radial fracture with or without ulnar involvement

You may not qualify if:

  • Active pregnancy
  • Surgery with combined anesthesia (locoregional and general)
  • Locoregional anesthesia with catheter insertion for postoperative analgesia
  • Individuals with chronic pain as defined by preexisting neuropathy of the operated arm, preexisting radiculopathy of the operated limb, complex regional pain syndrome, or fibromyalgia
  • Polytrauma
  • Inability to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIUSSS de l'estrie- CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

Location

Related Publications (2)

  • Heroux J, Bessette PO, Bedard S, Lamarche D, Gagnon A, Echave P, Loignon MJ, Patenaude N, Baillargeon JP, D'Aragon F. Functional recovery of wrist surgery with regional versus general anesthesia: a prospective observational study. Can J Anaesth. 2024 Jun;71(6):761-772. doi: 10.1007/s12630-023-02615-y. Epub 2023 Nov 6.

    PMID: 37932649DERIVED

  • Heroux J, Bessette PO, Belley-Cote E, Lamarche D, Echave P, Loignon MJ, Patenaude N, Baillargeon JP, D'Aragon F. Functional recovery with peripheral nerve block versus general anesthesia for upper limb surgery: a systematic review. BMC Anesthesiol. 2023 Mar 24;23(1):91. doi: 10.1186/s12871-023-02038-8.

    PMID: 36964490DERIVED

Study Officials

  • Frédérick D'Aragon

    Université de Sherbooke

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and CIP resident

Study Record Dates

First Submitted

July 29, 2020

First Posted

September 9, 2020

Study Start

August 30, 2019

Primary Completion

September 29, 2021

Study Completion

December 31, 2021

Last Updated

January 6, 2023

Record last verified: 2023-01

Locations

CA(1)