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NCT03495466 · ClinicalTrials.gov registry record · NA
Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
A NA study, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 53
- Enrollment target
NCT03495466: Completed NA study, sponsored by Ohio State University.
NCT03495466 is a NA study that has completed, run by Ohio State University. The registered enrollment target is 53 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03495466, a NA study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 53 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- PROCEDURE Local only anesthesia vs Local with sedation anesthesia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2016-02-04 |
| Est. Completion | 2018-12-31 |
| Phase | NA |
What the finished NCT03495466 record still lists
NCT03495466 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Local only anesthesia vs Local with sedation anesthesia is the first listed.
NCT03495466 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03495466 about?
NCT03495466 is a clinical study titled "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, ha...
What is the current status of trial NCT03495466?
This trial is currently completed. It is a NA study. The enrollment target is 53 participants. The study started on 2016-02-04. Estimated completion is 2018-12-31.
What interventions are being tested in trial NCT03495466?
The interventions under investigation include: Local only anesthesia vs Local with sedation anesthesia (PROCEDURE).
Who is sponsoring clinical trial NCT03495466?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03495466's enrollment target sits among peer trials
53 1271st of 2000 higher than 729 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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