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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.
The Ohio State Wexner Medical Center
Columbus, Ohio, United States
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.
Time frame: measure at first post-operative appointment after each surgery, an average of 12-18 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: measured at baseline and prior to each surgery,an average of 12-18 weeks
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