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.

Study Overview

• Status: Completed
• Conditions: Bilateral Carpal Tunnel Syndrome (Diagnosis)
• Intervention / Treatment: Procedure: Local only anesthesia vs Local with sedation anesthesia

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Wexner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Local only Anesthesia; 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; The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.
ACTIVE_COMPARATOR: Local with sedation anesthesia; 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; The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of individuals preferred surgery (local only and local with sedation) by VAS score	The study patient will be asked to rate their preferred surgery at the end of the study.	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	The study patient will rate how satisfied they were after each surgery.	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)	Beck Anxiety Inventory will be collected at baseline and on the days of surgery to analyze any increases or decreases in anxiety.	measured at baseline and prior to each surgery,an average of 12-18 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost of surgery- chart review	The investigators will review the cost billed to the study patients insurance after each surgery.	measured after each surgery,an average of 12-18 weeks
Time in surgical facility- chart review	The investigators will review the amount of time the study patients spent in the surgery center on the day of their surgery.	measured after each surgery, an average of 12-18 weeks

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2016
• Primary Completion (ACTUAL): December 31, 2018
• Study Completion (ACTUAL): December 31, 2018

Study Registration Dates

• First Submitted: March 20, 2018
• First Submitted That Met QC Criteria: April 4, 2018
• First Posted (ACTUAL): April 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 11, 2019
• Last Update Submitted That Met QC Criteria: July 9, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2015H0148

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No