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

NCT ID: NCT03495466

Last Updated: 2019-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-04
• Study Completion Date: 2018-12-31

Brief Summary

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.

Conditions

Bilateral Carpal Tunnel Syndrome (Diagnosis)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Local only Anesthesia

The patient will receive local only anesthesia during the first surgery and local with sedation anesthesia for their second surgery.

Group Type: ACTIVE_COMPARATOR

Local only anesthesia vs Local with sedation anesthesia

Intervention Type: PROCEDURE

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

Local with sedation anesthesia

The patient will receive local with sedation anesthesia during the first surgery and local only anesthesia for their second surgery.

Group Type: ACTIVE_COMPARATOR

Local only anesthesia vs Local with sedation anesthesia

Intervention Type: PROCEDURE

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

Interventions

Local only anesthesia vs Local with sedation anesthesia

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kanu Goyal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2015H0148

Identifier Type: -

Identifier Source: org_study_id