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Recovery of FunctionFUNCTIONNCT04541745

Functional Recovery Following Orthopedic Wrist Surgery Under Peripheral Nerve Block Versus General Anesthesia

An observational study of Recovery of Function, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Recovery of Function
How many people
72 participants
Where
1 siteCanada
Study dates
30 Aug 2019to 31 Dec 2021
How long will I take part?
12 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 18 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • CIUSSS de l'estrie- CHUS

    Sherbrooke, Quebec, J1H 5H3

Other trials in Canada

About this study

Official title: Prospective Cohort Study Comparing Functional Recovery Following Orthopedic Wrist Surgery Under Peripheral Nerve Block Versus General Anesthesia

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.

Read the detailed description

All patients undergoing orthopedic wrist surgery under locoregional or general anesthesia at the CIUSSS de l'Estrie-CHUS who meet the selection criteria will be approach to participate in this prospective single-center observational study. Using the visual analog scale and anesthesia scale, the pain and the satisfaction of the patient will be evaluated respectively 2 weeks postoperatively. At the second visit, 6 to 8 weeks postoperatively, the participant will complete the QuickDASH questionnaire to evaluate his functional recovery and the participant's pain will be reassessed with the visual analogue scale. Finally, 12 weeks postoperatively, the wrist-joint range of motion and grip-strength test results will be recorded. The participant will also be asked to complete the QuickDASH and PRWE (Patient-Rated Wrist Evaluation) questionnaires to reevaluate his functional recovery.

Keywords
Upper limb surgery, Functional recovery, Postoperative recovery, General anesthesia, Brachial plexus, Nerve block, Regional anesthesia, Peripheral anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks post-surgery

  2. 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.

    Measured: 12 weeks post-surgery

  3. 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

    Measured: 12 weeks post-surgery

  4. 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.

    Measured: 12 weeks post-surgery

Secondary outcomes (4)

  1. Pain- 2 weeks

    Post-operative pain score on the visual analogue scale. It is a 10 cm line on which the patient indicate their level of pain between 0 cm (no pain) and 10 cm (worst pain of their life).

    Measured: 2 weeks post-operative

  2. Pain - 6 weeks

    Post-operative pain score on the visual analogue scale. It is a 10 cm line on which the patient indicate their level of pain between 0 cm (no pain) and 10 cm (worst pain of their life).

    Measured: 6 weeks post-operative

  3. Functional recovery at 6 weeks

    Functional recovery following an orthopedic surgery under peripheral nerve block versus general anesthesia using the QuickDASH (The Quick Disabilities of Arm, Shoulder and Hand). The questionnaire consists of 11 questions scored from 1 to 5 (1 = no difficulty to 5 = unable). When all the questions are answered, the questionnaire calculate a percentage of disability. Higher scores indicate a greater level of disability.

    Measured: 6 weeks post-operative

  4. Patient satisfaction

    Satisfaction score on the visual analogue scale. It is a 10 cm line on which the patient indicate their level of satisfaction between 0 cm (not satisfied) and 10 (fully satisfied).

    Measured: 2 weeks post-operative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start30 Aug 2019
  3. Primary completion29 Sep 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (actual)
Target duration
12 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT04541745
Sponsor's protocol ID
2020-3241
Acronym
FUNCTION
Status last verified
Jan 2023
First submitted
29 Jul 2020
Last updated
6 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37932649

  • 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.

    PubMed 36964490

Questions about this trial

What is this clinical trial studying?

An observational study of Recovery of Function, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Functional recovery using the QuickDASH (Quick Disabilities of Arm, Shoulder and Hand) questionnaire (time frame: 12 weeks post-surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04541745, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.

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