Comparison of Local Only Anesthesia Versus Sedation in Patients Undergoing Bilateral Carpal Tunnel Release
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 4/17/2018 |
| Start Date: | February 4, 2016 |
| End Date: | December 31, 2019 |
| Contact: | Beths Sheridan, MPH, MACPR |
| Email: | elizabeth.sheridan@osumc.edu |
| Phone: | 614-293-9013 |
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
