Back to resultsComparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
Primary Purpose
Bilateral Carpal Tunnel Syndrome (Diagnosis)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Local only anesthesia vs Local with sedation anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Bilateral Carpal Tunnel Syndrome (Diagnosis)
Eligibility 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
Sites / Locations
- The Ohio State Wexner Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Local only Anesthesia
Local with sedation anesthesia
Arm Description
The patient will receive local only anesthesia during the first surgery and local with sedation anesthesia for their second surgery.
The patient will receive local with sedation anesthesia during the first surgery and local only anesthesia for their second surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03495466
Brief Title
Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
Official Title
Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
February 4, 2016 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bilateral Carpal Tunnel Syndrome (Diagnosis)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local only Anesthesia
Arm Type
Active Comparator
Arm Description
The patient will receive local only anesthesia during the first surgery and local with sedation anesthesia for their second surgery.
Arm Title
Local with sedation anesthesia
Arm Type
Active Comparator
Arm Description
The patient will receive local with sedation anesthesia during the first surgery and local only anesthesia for their second surgery.
Intervention Type
Procedure
Intervention Name(s)
Local only anesthesia vs Local with sedation anesthesia
Intervention Description
The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.
Primary Outcome Measure Information:
Title
Measurement of patients perspective and preferences with their surgeries (local only and local with sedation) by VAS and multiple choice questions.
Description
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
Secondary Outcome Measure Information:
Title
Measurement of individuals preferred surgery (local only and local with sedation) by VAS score
Description
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
Title
Measurement of individuals satisfaction with each surgery (local only and local with sedation) by VAS score
Description
The study patient will rate how satisfied they were after each surgery.
Time Frame
measured six week follow-up after each surgery
Title
Measurement of level of anxiety about each type of surgery (local only and local with sedation) by Beck Anxiety Inventory (questionnaire)
Description
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
Other Pre-specified Outcome Measures:
Title
Cost of surgery- chart review
Description
The investigators will review the cost billed to the study patients insurance after each surgery.
Time Frame
measured after each surgery,an average of 12-18 weeks
Title
Time in surgical facility- chart review
Description
The investigators will review the amount of time the study patients spent in the surgery center on the day of their surgery.
Time Frame
measured after each surgery, an average of 12-18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
The Ohio State Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
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Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
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