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NCT Number: NCT04201652

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

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.

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Key information

Conditions

Carpal Tunnel Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7N 5E5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Superficial local anesthetic infiltration

Procedure

Superficial infiltration of local anesthetic for carpal tunnel release.

Deep local anesthetic infiltration

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2019
Registry last updated
Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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