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

NCT03495466 | Completed

• 1 other identifier: 2015H0148
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (3)

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

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

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

  measured six week follow-up after each surgery

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

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

Other Outcomes (2)

• Cost of surgery- chart review

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

• Time in surgical facility- chart review

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

Study Arms (2)

Local only Anesthesia

ACTIVE COMPARATOR

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

Procedure: Local only anesthesia vs Local with sedation anesthesia

Local with sedation anesthesia

ACTIVE COMPARATOR

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

Procedure: Local only anesthesia vs Local with sedation anesthesia

Interventions

Local only anesthesia vs Local with sedation anesthesia PROCEDURE

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

Local only Anesthesia; Local with sedation anesthesia

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 20, 2018
• First Posted: April 12, 2018
• Study Start: February 4, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: July 11, 2019

Record last verified: 2019-07

Locations

US (1)