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Completed

NCT Number: NCT03495466

Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release

The study design is a prospective randomized control trial. Four surgeons will enroll up to 30 patients in the study. Patients will be asked to participate if they plan to undergo bilateral carpal tunnel release with one of the study surgeons, are greater than 18 years of age but younger than 89, have had no prior carpal tunnel surgery, and agree to undergo carpal tunnel surgery under two different types of anesthesia. If patients meet these criteria and agree to participate in the study, they will be consenting to have one hand operated on with local only anesthesia and the other hand with local anesthesia with sedation. The patient will randomly be assigned to have one of the two anesthetic methods for the first carpal tunnel release, followed by the other anesthetic for the second carpal tunnel release. The two surgeries will be completed by the same surgeon and may be performed at any time interval apart; however, the investigators will recommend that patients get the second surgery within 4 weeks of the first. The particular surgical technique of carpal tunnel release will be performed according to the individual surgeon's preference, but the same technique will be used on both wrists. The surgeon will discuss the proposed advantages and disadvantages of each anesthetic method prior to enrolling the patient (advantages and disadvantages discussed above). The treating surgeons will continue to utilize their standard surgical technique on each side, regardless of a patient's participation in the study.

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Key information

Conditions

Bilateral Carpal Tunnel Syndrome (Diagnosis) Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Patients with a diagnosis of bilateral carpal tunnel syndrome and who have been recommended to undergo bilateral carpal tunnel release will be recruited to the study. Standard diagnostic criteria will be utilized by the surgeon including symptoms, objective signs on physical exam, and adjunct studies such as electromyography, nerve conduction and neuromuscular ultrasound. These patients may be identified in any of four surgeon offices, all of whom are fellowship-trained in hand and upper extremity surgery. As in standard practice, the participating surgeons will screen individuals to identify any contraindications for either method of anesthesia. Patients meeting the general inclusion and exclusion criteria listed below will be eligible to participate. Should any questions arise regarding an individual's eligibility or safety, a consultation with Dr. Mike Guertin, anesthesiologist, will be obtained. Inclusion criteria include: - Individuals who are able to give consent - Individuals who are at least 18 years of age but no older than 89. - Individuals who require bilateral carpal tunnel release surgery - Willingness to undergo each type of anesthesia

Exclusion criteria

include: - Age < 18 years and > 89 years - Prior history of carpal tunnel release - Allergy to local anesthetics - Medical conditions that would exclude the participant from being a candidate for sedation during surgery (examples: respiratory conditions (chronic obstructive pulmonary disease, lung cancer, sickle cell disease); liver and kidney disease.) - Any other contraindications for sedation not listed - Unwillingness to participate in the study - Unable to consent for themselves -First surgery being performed endoscopically or open and the second surgery requiring the opposite technique - Prisoners

Treatment and study plan

Local only anesthesia vs Local with sedation anesthesia

Procedure

The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.

Primary outcomes

  1. Measurement of patients perspective and preferences with their surgeries (local only and local with sedation) by VAS and multiple choice questions.

    Time frame: measure at first post-operative appointment after each surgery, an average of 12-18 weeks

    A post-operative questionnaire has been compiled to capture study patient perspectives and preferences with their surgeries. The study patients will fill out this questionnaires during their first post-operative visits after each surgery.

Secondary outcomes

  1. Measurement of individuals preferred surgery (local only and local with sedation) by VAS score

    Time frame: measured after both surgeries have been completed,an average of 12-18 weeks

    The study patient will be asked to rate their preferred surgery at the end of the study.

  2. Measurement of individuals satisfaction with each surgery (local only and local with sedation) by VAS score

    Time frame: measured six week follow-up after each surgery

    The study patient will rate how satisfied they were after each surgery.

  3. Measurement of level of anxiety about each type of surgery (local only and local with sedation) by Beck Anxiety Inventory (questionnaire)

    Time frame: measured at baseline and prior to each surgery,an average of 12-18 weeks

    Beck Anxiety Inventory will be collected at baseline and on the days of surgery to analyze any increases or decreases in anxiety.

Other outcomes

  1. Cost of surgery- chart review

    Time frame: measured after each surgery,an average of 12-18 weeks

    The investigators will review the cost billed to the study patients insurance after each surgery.

  2. Time in surgical facility- chart review

    Time frame: measured after each surgery, an average of 12-18 weeks

    The investigators will review the amount of time the study patients spent in the surgery center on the day of their surgery.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Jul 11, 2019

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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