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Completed

NCT Number: NCT04541745

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.

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Key information

Conditions

Recovery of Function

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIUSSS de l'estrie- CHUS

Sherbrooke, Quebec, J1H 5H3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

  1. 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. 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).

  3. 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.

  4. 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).

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Registry information

Official study title

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

Acronym: FUNCTION

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 9, 2020
Registry last updated
Jan 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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