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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

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.

Condition or disease Intervention/treatment Phase
Bilateral Carpal Tunnel Syndrome (Diagnosis) Procedure: Local only anesthesia vs Local with sedation anesthesia Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
Actual Study Start Date : February 4, 2016
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495466


Locations
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United States, Ohio
The Ohio State Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
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Responsible Party: Kanu Goyal, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT03495466    
Other Study ID Numbers: 2015H0148
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs