An interventional study of Marcaine 0.5 % Injectable Solution in Stress Urinary Incontinence, sponsored by Barzilai Medical Center. Completed at 1 site in Israel. Open to female participants aged 35 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-07-14.
Sponsored by Barzilai Medical Center · Not applicable, Interventional, and Treatment
BACKGROUND:
Compare the pain intensity after TVT-O procedure in the inner part of the thigh where the anesthetic substance will be injected versus the inner part of of the thigh without anesthetic injection in the same woman.
The advantage of this work is that this method of testing neutralizes the effect of pain thresholds of different women.
If an advantage will be found in injecting anesthetic as a reduction in postoperative pain, it could be recommended for all women who undergo surgery of this kind.
METHODS:
Preoperative women will be offered the opportunity to participate in the study after a detailed explanation of the study and determine a date for an elective TVT-O procedure. After signing the Informed Consent Form, they will undergo a TVT-O procedure with injection of anesthetic into one of the obturators membranes. In a random order, Marcaine 5-ml will be injected into a left or right obturator membrane.
One side with Marcaine (Bupivacaine HCL) 0.5% 5 mg / mL Injection,opposite side without injection of any anesthetic.
Before and after surgery, patients will receive Visual Analogue Scale (VAS) instruction and will be polled at the following time points: 1,6,12,24 hours after surgery per inner part of the thigh separately. Each patient will rate the intensity of the pain she feels on the pain questionnaire at each of the time points mentioned before.
651 studies on the registry are indexed under Urinary Incontinence, Stress; 120 are open to participants now.
This study's enrollment of 22 is below the median of 68 across 506 interventional studies indexed under Urinary Incontinence, Stress.
Browse Urinary Incontinence, Stress studies →Barzilai Medical Center is the lead sponsor of 26 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Drug: Marcaine 0.5 % Injectable Solution
Intra -operative injection into obturator membrane
Leg pain
VAS score
Time frame: 1 hour after surgery
Leg pain
VAS score
Time frame: 6 hours after surgery
Leg pain
VAS score
Time frame: 12 hours after surgery
Leg pain
VAS score
Time frame: 24 hours after surgery
Plan to share: No
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine
Urinary Incontinence, Stress →
Barzilai Medical Center