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

NCT03632304 | Completed

• 1 other identifier: 2018-3814
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hand Surgery; Quality of Recovery; Hand Injuries; Hand Fracture; Hand Tendon Injury; Anesthesia, Local

Keywords

hand surgery; quality of recovery; local anesthesia; regional anesthesia; QoR-15

Outcome Measures

Primary Outcomes (1)

• Quality of Recovery 15 Questionnaire (QoR-15)

  This psychometrically tested and validated 15-items questionnaire measures patient-reported quality of recovery from surgery and anesthesia on the first post-operative day. Each item consists of a question related to the patient's post-operative recovery and is rated by the patient on a 10-point scale, where 0 means "none of the time" and 10 means "all of the time". The total combined score is obtained from the summation of 15 sub-scores and ranges from 0 to 150, and is used to assess and compare the patient's quality of recovery quantitatively between different interventions. A higher number on the score indicates an improved patient recovery experience. This scale has been validated in the ambulatory surgery setting.

  At 24 hours post-surgery

Secondary Outcomes (2)

• Block performance time, onset time, and nonsurgical time

  Within 24 hours of surgery

• Opioid use at 24 hours after surgery

  At 24 hours post-surgery

Study Arms (2)

Brachial plexus block (infraclavicular)

NO INTERVENTION

The standard of care at our institution. Performed by experienced regional anesthetists.

Local anesthesia with minimal sedation

ACTIVE COMPARATOR

The comparison group. Performed by the operating surgeon.

Procedure: Local anesthesia with minimal sedation

Interventions

Local anesthesia with minimal sedation PROCEDURE

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.

Local anesthesia with minimal sedation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient age 18 and older
• Hand surgeries distal to carpal bones
• Trauma and elective cases
• Under 2 hours estimated surgical duration
• Consents to research

You may not qualify if:

• Patient refusal
• Allergy to local anesthetics
• Surgery proximal to the carpal bones
• BMI \> 40 kg/m2
• Non-compressive neurological disease of the upper extremity
• Daily use of opioids for greater than 2 weeks prior to surgery
• History of complex regional pain syndrome (CRPS)
• Patients with high anxiety or severe post-traumatic stress disorder

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (2)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

St-Mary's Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (5)

• Lalonde DH. Reconstruction of the hand with wide awake surgery. Clin Plast Surg. 2011 Oct;38(4):761-9. doi: 10.1016/j.cps.2011.07.005.

  PMID: 22032599 BACKGROUND

• Lalonde D. Minimally invasive anesthesia in wide awake hand surgery. Hand Clin. 2014 Feb;30(1):1-6. doi: 10.1016/j.hcl.2013.08.015. Epub 2013 Nov 9.

  PMID: 24286736 BACKGROUND

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Soberon JR Jr, Crookshank JW 3rd, Nossaman BD, Elliott CE, Sisco-Wise LE, Duncan SF. Distal Peripheral Nerve Blocks in the Forearm as an Alternative to Proximal Brachial Plexus Blockade in Patients Undergoing Hand Surgery: A Prospective and Randomized Pilot Study. J Hand Surg Am. 2016 Oct;41(10):969-977. doi: 10.1016/j.jhsa.2016.07.092. Epub 2016 Aug 11.

  PMID: 27524691 BACKGROUND

• Meng F, Baradaran A, Jaberi MM, Tran QH, Finlayson R, Luc M, Xu L, Thibaudeau S. Patient-Reported Quality of Recovery after Local Anesthesia versus Brachial Plexus Block in Hand Surgery: A Randomized Controlled Study. Plast Reconstr Surg. 2023 Dec 1;152(6):1287-1296. doi: 10.1097/PRS.0000000000010688. Epub 2023 May 16.

  PMID: 37189224 DERIVED

MeSH Terms

Conditions

Hand Injuries

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Fanyi Meng, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Division of Plastic and Reconstructive Surgery

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 15, 2018
• Study Start: August 17, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)