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

Primary Purpose

Carpal Tunnel, Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Superficial local anesthetic infiltration
Deep local anesthetic infiltration
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel focused on measuring Local Anesthetic, WALANT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • > 18 years of age
  • Undergoing carpal tunnel release

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Saskatchewan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Superficial

Deep

Arm Description

Intervention: Superficial local anesthetic infiltration.

Intervention: Superficial and deep local anesthetic infiltration.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Intensity of Pain Post-Procedure: VAS
Intensity of pain after 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.
Boston Carpal Tunnel Questionnaire Score
Boston Carpal Tunnel Questionnaire Score. The minimum score is 19 and would indicate low symptom severity and the maximum score is 95 which would indicate high symptom severity.

Full Information

First Posted
December 13, 2019
Last Updated
September 29, 2021
Sponsor
University of Saskatchewan
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1. Study Identification

Unique Protocol Identification Number
NCT04201652
Brief Title
Comparing Superficial vs. Deep Local Anesthetic Infiltration to Improve Patient Experience During Carpal Tunnel Release
Official Title
Comparing Superficial vs. Deep Local Anesthetic Infiltration to Improve Patient Experience During Carpal Tunnel Release
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
March 10, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel, Carpal Tunnel Syndrome
Keywords
Local Anesthetic, WALANT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized into one of two interventional groups for the duration of the study.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Superficial
Arm Type
Active Comparator
Arm Description
Intervention: Superficial local anesthetic infiltration.
Arm Title
Deep
Arm Type
Active Comparator
Arm Description
Intervention: Superficial and deep local anesthetic infiltration.
Intervention Type
Procedure
Intervention Name(s)
Superficial local anesthetic infiltration
Intervention Description
Superficial infiltration of local anesthetic for carpal tunnel release.
Intervention Type
Procedure
Intervention Name(s)
Deep local anesthetic infiltration
Intervention Description
Deep and superficial infiltration of local anesthetic for carpal tunnel release.
Primary Outcome Measure Information:
Title
Intensity of Pain During Procedure: VAS
Description
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.
Time Frame
Immediately after the procedure
Title
Intensity of Pain During Local Anesthetic Infiltration: VAS
Description
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.
Time Frame
Immediately after the procedure
Secondary Outcome Measure Information:
Title
Intensity of Pain Post-Procedure: VAS
Description
Intensity of pain after 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.
Time Frame
2, 8, and 24 hours after the procedure.
Title
Boston Carpal Tunnel Questionnaire Score
Description
Boston Carpal Tunnel Questionnaire Score. The minimum score is 19 and would indicate low symptom severity and the maximum score is 95 which would indicate high symptom severity.
Time Frame
Before the procedure and 3 months after the procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: > 18 years of age Undergoing carpal tunnel release Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Sauder, MD, FRCSC
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 5E5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29871567
Citation
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.
Results Reference
background
PubMed Identifier
17046117
Citation
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.
Results Reference
background
PubMed Identifier
24227926
Citation
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.
Results Reference
background
PubMed Identifier
24286736
Citation
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.
Results Reference
background
PubMed Identifier
3249135
Citation
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.
Results Reference
background
PubMed Identifier
20007415
Citation
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.
Results Reference
background
PubMed Identifier
23566722
Citation
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.
Results Reference
background

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

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