Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic
NCT ID: NCT03479996
Last Updated: 2020-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2018-11-13
2020-06-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Anesthetic
Marcaine 0.5 % Injectable Solution
Intra -operative injection into obturator membrane
Control
No interventions assigned to this group
Interventions
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Marcaine 0.5 % Injectable Solution
Intra -operative injection into obturator membrane
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
35 Years
85 Years
FEMALE
No
Sponsors
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Barzilai Medical Center
OTHER
Responsible Party
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ofer gemer
Director of gynecological surgery, BMC
Principal Investigators
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Ofer Gemer, Prof.
Role: PRINCIPAL_INVESTIGATOR
Barzilai Medical Center
Locations
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Barzilay University Medical Center
Ashkelon, , Israel
Countries
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References
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Latthe PM, Foon R, Toozs-Hobson P. Transobturator and retropubic tape procedures in stress urinary incontinence: a systematic review and meta-analysis of effectiveness and complications. BJOG. 2007 May;114(5):522-31. doi: 10.1111/j.1471-0528.2007.01268.x. Epub 2007 Mar 16.
Cheng D, Liu C. Tension-free vaginal tape-obturator in the treatment of stress urinary incontinence: a prospective study with five-year follow-up. Eur J Obstet Gynecol Reprod Biol. 2012 Apr;161(2):228-31. doi: 10.1016/j.ejogrb.2012.01.011. Epub 2012 Feb 13.
Duckett J, Baranowski A. Pain after suburethral sling insertion for urinary stress incontinence. Int Urogynecol J. 2013 Feb;24(2):195-201. doi: 10.1007/s00192-012-1863-3. Epub 2012 Jul 3.
Hazewinkel MH, Hinoul P, Roovers JP. Persistent groin pain following a trans-obturator sling procedure for stress urinary incontinence: a diagnostic and therapeutic challenge. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Mar;20(3):363-5. doi: 10.1007/s00192-008-0714-8. Epub 2008 Sep 4.
Tommaselli GA, Di Carlo C, Formisano C, Fabozzi A, Nappi C. Effect of local infiltration analgesia on post-operative pain following TVT-O: a double-blind, placebo-controlled randomized study. Arch Gynecol Obstet. 2014 Aug;290(2):283-9. doi: 10.1007/s00404-014-3186-8. Epub 2014 Mar 6.
Volchok V, Kapustian V, Namazov A, Zangen R, Anteby EY, Gemer O. Intra-obturator bupivacaine injection and post-operative pain following the trans-obturator tension-free vaginal tape procedure: randomized study. Arch Gynecol Obstet. 2024 Jun;309(6):2937-2941. doi: 10.1007/s00404-024-07533-y. Epub 2024 May 14.
Other Identifiers
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BRZ 0005-18 CTIL
Identifier Type: -
Identifier Source: org_study_id
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