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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495466
Recruitment Status : Completed
First Posted : April 12, 2018
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Kanu Goyal, Ohio State University

Tracking Information
First Submitted Date  ICMJE March 20, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date July 11, 2019
Actual Study Start Date  ICMJE February 4, 2016
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
Measurement of patients perspective and preferences with their surgeries (local only and local with sedation) by VAS and multiple choice questions. [ Time Frame: measure at first post-operative appointment after each surgery, an average of 12-18 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2018)
  • Measurement of individuals preferred surgery (local only and local with sedation) by VAS score [ Time Frame: measured after both surgeries have been completed,an average of 12-18 weeks ]
    The study patient will be asked to rate their preferred surgery at the end of the study.
  • Measurement of individuals satisfaction with each surgery (local only and local with sedation) by VAS score [ Time Frame: measured six week follow-up after each surgery ]
    The study patient will rate how satisfied they were after each surgery.
  • Measurement of level of anxiety about each type of surgery (local only and local with sedation) by Beck Anxiety Inventory (questionnaire) [ Time Frame: measured at baseline and prior to each surgery,an average of 12-18 weeks ]
    Beck Anxiety Inventory will be collected at baseline and on the days of surgery to analyze any increases or decreases in anxiety.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 4, 2018)
  • Cost of surgery- chart review [ Time Frame: measured after each surgery,an average of 12-18 weeks ]
    The investigators will review the cost billed to the study patients insurance after each surgery.
  • Time in surgical facility- chart review [ Time Frame: measured after each surgery, an average of 12-18 weeks ]
    The investigators will review the amount of time the study patients spent in the surgery center on the day of their surgery.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
Official Title  ICMJE Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bilateral Carpal Tunnel Syndrome (Diagnosis)
Intervention  ICMJE Procedure: Local only anesthesia vs Local with sedation anesthesia
The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Local only anesthesia vs Local with sedation anesthesia
  • 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.
    Intervention: Procedure: Local only anesthesia vs Local with sedation anesthesia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019)
53
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2018)
60
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495466
Other Study ID Numbers  ICMJE 2015H0148
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kanu Goyal, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ohio State University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP