← Back to Search

Local only Anesthesia for Bilateral Carpal Tunnel Syndrome

N/A
Waitlist Available
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up measured six week follow-up after each surgery
Awards & highlights

Study 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.

Eligible Conditions
  • Bilateral Carpal Tunnel Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~measured after each surgery,an average of 12-18 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and measured after each surgery,an average of 12-18 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of patients perspective and preferences with their surgeries (local only and local with sedation) by VAS and multiple choice questions.
Secondary outcome measures
Measurement of individuals preferred surgery (local only and local with sedation) by VAS score
Measurement of individuals satisfaction with each surgery (local only and local with sedation) by VAS score
Measurement of level of anxiety about each type of surgery (local only and local with sedation) by Beck Anxiety Inventory (questionnaire)
Other outcome measures
Cost of surgery- chart review
Time in surgical facility- chart review

Trial Design

2Treatment groups
Active Control
Group I: Local only AnesthesiaActive Control1 Intervention
The patient will receive local only anesthesia during the first surgery and local with sedation anesthesia for their second surgery.
Group II: Local with sedation anesthesiaActive Control1 Intervention
The patient will receive local with sedation anesthesia during the first surgery and local only anesthesia for their second surgery.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
844 Previous Clinical Trials
639,456 Total Patients Enrolled
~6 spots leftby Jun 2025