Comparing Superficial vs. Deep Local Anesthetic Infiltration to Improve Patient Experience During Carpal Tunnel Release

NCT04201652 | Completed

• 1 other identifier: Bio 1439
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: When comparing superficial infiltration of local anesthetic to superficial and deep infiltration of local anesthetic in the setting of carpal tunnel release, the null hypothesis is that there will be no significant difference between the two techniques. Background and study rationale: Carpal tunnel syndrome is a very common clinical problem with significant patient burden that can be reliably treated with surgical carpal tunnel release. To minimize operating room time burdens and to improve patient recovery time, this procedure is generally performed with the patient wide awake using local anesthetic. While the majority of patients are able to tolerate this type of procedure, there is always a possibility of some discomfort or pain experienced during the procedure. The investigators would like to compare two local anesthetic infiltration techniques to determine which is best to provide the least amount of pain or discomfort during a carpal tunnel release. The two methods are subcutaneous infiltration alone (superficial) and subcutaneous infiltration with infiltration into the carpal tunnel (deep). Research Design: This study design is a prospective randomized control trial. Methodology: Patients will be recruited and randomized on the morning of their surgery to undergo either superficial or superficial and deep local anesthetic infiltration using 10cc of 1% lidocaine with epinephrine buffered with 8.4% sodium bicarbonate. They will be blinded as to which group they are in. Participants will complete the Boston Carpal Tunnel Questionnaire as a baseline for comparison as well as a brief questionnaire on demographics. After the procedure, participants will complete a short questionnaire about any pain experienced during the administration of the local anesthetic and during the procedure. Presence and intensity of pain during the procedure are the primary outcome of this study. Secondary outcomes include pain rating at 2, 8, and 24 hours post-procedure and a follow up Boston Carpal Tunnel Questionnaire score at 3 months. The surgeon will also make note whether there is any visible evidence of damage to the median nerve from deep infiltration at the time of surgery. Statistical Analysis: The two groups (superficial vs. deep) will be compared directly for each of the outcomes listed in the methodology.

Conditions

Carpal Tunnel; Carpal Tunnel Syndrome

Keywords

Local Anesthetic; WALANT

Outcome Measures

Primary Outcomes (2)

• Intensity of Pain During Procedure: VAS

  Intensity of pain during the procedure, scored on a 10-point VAS (Visual Analogue Scale) for pain, where 0 is no pain and 10 is the worst pain possible.

  Immediately after the procedure

• Intensity of Pain During Local Anesthetic Infiltration: VAS

  Intensity of pain during the local anesthetic infiltration, scored on a 10-point VAS (Visual Analogue Scale) for pain, where 0 is no pain and 10 is the worst pain possible.

  Immediately after the procedure

Secondary Outcomes (2)

• Intensity of Pain Post-Procedure: VAS

  2, 8, and 24 hours after the procedure.

• Boston Carpal Tunnel Questionnaire Score

  Before the procedure and 3 months after the procedure.

Study Arms (2)

Superficial

ACTIVE COMPARATOR

Intervention: Superficial local anesthetic infiltration.

Procedure: Superficial local anesthetic infiltration

Deep

ACTIVE COMPARATOR

Intervention: Superficial and deep local anesthetic infiltration.

Procedure: Deep local anesthetic infiltration

Interventions

Superficial local anesthetic infiltration PROCEDURE

Superficial infiltration of local anesthetic for carpal tunnel release.

Superficial

Deep local anesthetic infiltration PROCEDURE

Deep and superficial infiltration of local anesthetic for carpal tunnel release.

Deep

Eligibility Criteria

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

You may qualify if:

• \> 18 years of age
• Undergoing carpal tunnel release

You may not qualify if:

• Patients undergoing repeat carpal tunnel release
• Patients undergoing simultaneous procedures for other hand/wrist pathology at the time of carpal tunnel release (i.e. trigger finger release, Dupuytren's, etc.)
• Patients with a history of Rheumatoid Arthritis or a history or previous trauma or surgery to the local area (i.e. distal radius fracture)
• Patients who lack the capacity to provide informed consent or understand the nature of the project

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

Location

Related Publications (7)

• Iqbal HJ, Doorgakant A, Rehmatullah NNT, Ramavath AL, Pidikiti P, Lipscombe S. Pain and outcomes of carpal tunnel release under local anaesthetic with or without a tourniquet: a randomized controlled trial. J Hand Surg Eur Vol. 2018 Oct;43(8):808-812. doi: 10.1177/1753193418778999. Epub 2018 Jun 5.

  PMID: 29871567 BACKGROUND

• Patil S, Ramakrishnan M, Stothard J. Local anaesthesia for carpal tunnel decompression: a comparison of two techniques. J Hand Surg Br. 2006 Dec;31(6):683-6. doi: 10.1016/j.jhsb.2006.08.008.

  PMID: 17046117 BACKGROUND

• Pressman A, Doumit G, Rosaeg O, Bell M. A double-blind randomized controlled trial showing the analgesic and anesthetic properties of lidocaine E to be equivalent to those of ropivicaine and bupivacaine in carpal tunnel release surgery. Can J Plast Surg. 2005 Winter;13(4):173-6. doi: 10.1177/229255030501300401.

  PMID: 24227926 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

• Altissimi M, Mancini GB. Surgical release of the median nerve under local anaesthesia for carpal tunnel syndrome. J Hand Surg Br. 1988 Nov;13(4):395-6. doi: 10.1016/0266-7681_88_90163-5.

  PMID: 3249135 BACKGROUND

• Tomlinson PJ, Field J. Warm or refrigerated local anaesthetic for open carpal tunnel release: a single blind randomized controlled study. J Hand Surg Eur Vol. 2010 Mar;35(3):232-3. doi: 10.1177/1753193409354138. Epub 2009 Dec 9.

  PMID: 20007415 BACKGROUND

• Lee HJ, Cho YJ, Gong HS, Rhee SH, Park HS, Baek GH. The effect of buffered lidocaine in local anesthesia: a prospective, randomized, double-blind study. J Hand Surg Am. 2013 May;38(5):971-5. doi: 10.1016/j.jhsa.2013.02.016. Epub 2013 Apr 6.

  PMID: 23566722 BACKGROUND

MeSH Terms

Conditions

Median Neuropathy; Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• David Sauder, MD, FRCSC

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgery, Assistant Professor

Model Details: Participants will be randomized into one of two interventional groups for the duration of the study.

Study Record Dates

• First Submitted: December 13, 2019
• First Posted: December 17, 2019
• Study Start: November 27, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 16, 2020
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)