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

September 29, 2021 updated by: David Sauder, University of Saskatchewan

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 5E5
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Superficial
Intervention: Superficial local anesthetic infiltration.
Procedure: Superficial local anesthetic infiltration
Superficial infiltration of local anesthetic for carpal tunnel release.
Active Comparator: Deep
Intervention: Superficial and deep local anesthetic infiltration.
Procedure: Deep local anesthetic infiltration
Deep and superficial infiltration of local anesthetic for carpal tunnel release.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of Pain During Procedure: VAS
Time Frame: Immediately after the procedure
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
Time Frame: Immediately after the procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of Pain Post-Procedure: VAS
Time Frame: 2, 8, and 24 hours after the procedure.
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.
2, 8, and 24 hours after the procedure.
Boston Carpal Tunnel Questionnaire Score
Time Frame: Before the procedure and 3 months after the procedure.
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.
Before the procedure and 3 months after the procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Saskatchewan

Investigators

  • Principal Investigator: David Sauder, MD, FRCSC, University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2019

Primary Completion (Actual)

March 10, 2020

Study Completion (Actual)

March 16, 2020

Study Registration Dates

First Submitted

December 13, 2019

First Submitted That Met QC Criteria

December 16, 2019

First Posted (Actual)

December 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 1, 2021

Last Update Submitted That Met QC Criteria

September 29, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bio 1439

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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