NCT03632304

Local Anesthesia With Minimal Sedation and Brachial Plexus Block in Hand Surgery

Completed NA Last updated 21 April 2021

What this trial tests

NA trial testing Local anesthesia with minimal sedation in Hand Surgery in 105 participants. Completed in 30 June 2020.

Timeline

17 August 2018

Primary endpoint
30 June 2020

30 June 2020

Quick facts

Lead sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	105
Start date	17 August 2018
Primary completion	30 June 2020
Estimated completion	30 June 2020
Sites	2 locations across Canada

Drugs / interventions tested

• Local anesthesia with minimal sedation

Conditions studied

• Hand Surgery — all drugs for Hand Surgery →
• Quality of Recovery — all drugs for Quality of Recovery →
• Hand Injuries — all drugs for Hand Injuries →
• Hand Fracture — all drugs for Hand Fracture →

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Who can join

18 and older, any sex, with Hand Surgery or Quality of Recovery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A major innovation in hand surgery in the last decade is the popularization of Wide Awake Hand Surgery (WAHS). This technique consists of numbing the surgical area with local anesthesia with epinephrine and allowing the patient to actively move their hand intra-operatively to assess the strength and quality of repairs or fixations. Despite its theoretical advantages, the application in clinical practice has seldom spread further than simple hand operations, such as carpal tunnel and trigger finger releases. In many institutions, the current standard of care for hand surgery is the brachial plexus block. The primary objective of the study to directly compare the effects of local anesthesia with minimal sedation, performed by the surgeon, and the brachial plexus block, performed by the anesthesiologist, on patient-reported quality of recovery.

Currently, there are no studies in the surgical literature directly comparing patient-reported quality of recovery, post-operative pain control, or time efficiency between local anesthesia and the brachial plexus block in hand surgery. This lack of information is a major impediment to the acceptance and adoption of a simple yet effective anesthesia technique that may increase patient satisfaction and time efficiency in the operating room. This proposed prospective randomized controlled study will quantitatively compare local anesthesia and brachial plexus block on three fronts: 1) patient-reported recovery at 24-hours post-surgery using the validated Quality of Recovery 15 score (QoR-15), 2) post-operative pain and opioid use at 24-hours post-surgery, and 3) nonsurgical time (defined as the time elapsed from one surgery's end time to the next surgery's start time) as a metric for turnover efficiency. The investigators hypothesize that patients randomized to the local anesthesia group will have a more positive recovery experience, a similar pain profile compared to the brachial plexus block despite common beliefs, and a shorter anesthesia-related and nonsurgical time.

The importance of patient-centered care cannot be understated in a successful and high-quality health care system. The results of this study will provide valuable information regarding the patient experience during their post- operative recovery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.