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

January 4, 2023 updated by: Jennifer Héroux, Université de Sherbrooke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 5H3
        • CIUSSS de l'Estrie- CHUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability 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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Functional recovery using the QuickDASH (Quick Disabilities of Arm, Shoulder and Hand) questionnaire
Time Frame: 12 weeks post-surgery
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
Time Frame: 12 weeks post-surgery
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
Time Frame: 12 weeks post-surgery
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
Time Frame: 12 weeks post-surgery
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain- 2 weeks
Time Frame: 2 weeks post-operative
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).
2 weeks post-operative
Pain - 6 weeks
Time Frame: 6 weeks post-operative
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).
6 weeks post-operative
Functional recovery at 6 weeks
Time Frame: 6 weeks post-operative
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.
6 weeks post-operative
Patient satisfaction
Time Frame: 2 weeks post-operative
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).
2 weeks post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Frédérick D'Aragon, Université de Sherbooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 29, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 9, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-3241

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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