An interventional study of Local only anesthesia vs Local with sedation anesthesia in Bilateral Carpal Tunnel Syndrome (Diagnosis), sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2019-07-11.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
Ohio State University is the lead sponsor of 663 studies on the registry; 148 are open to participants now.
Of its 67 completed or terminated interventional studies of FDA-regulated products, 49 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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 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 (, 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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
Time frame: measure at first post-operative appointment after each surgery, an average of 12-18 weeks
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.
Time frame: measured after both surgeries have been completed,an average of 12-18 weeks
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.
Time frame: measured six week follow-up 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.
Time frame: measured at baseline and prior to each surgery,an average of 12-18 weeks
Cost of surgery- chart review
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
Time in surgical facility- chart review
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
Ran from Feb 2016 to primary completion in Dec 2018, 34 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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