CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Local anesthesia with minimal sedationprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03632304
NCT03632304N/ACompleted

The Quality of Recovery of Local Anesthesia With Minimal Sedation and Brachial Plexus Block in Hand Surgery: A Randomized Controlled Study

In Brief

A clinical study evaluating Local anesthesia with minimal sedation for Hand Surgery and 5 related conditions. Completed, enrolled 105 participants across 2 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 15, 2018
Enrollment StartAug 17, 2018
Primary CompletionJun 30, 2020
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 7.9 years ago

Interventions

Local anesthesia with minimal sedationprocedure

The operating surgeon will perform a digital or wrist block to numb the surgical area prior to the surgery, instead of using a brachial plexus block.