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

Recovery of Function Clinical Trial

— FUNCTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04541745
• Other study ID #: 2020-3241
• Status: Completed
• Start date: August 30, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2023
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Recovery of Function

Locations

Country	Name	City	State
Canada	CIUSSS de l'estrie- CHUS	Sherbrooke	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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).	2 weeks post-operative
Secondary	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).	6 weeks post-operative
Secondary	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.	6 weeks post-operative
Secondary	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).	2 weeks post-operative