Clinical trial NCT03479996: Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic
Official title: Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Barzilai Medical Center
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 22
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

• Women undergoing TVT-O

Exclusion Criteria:

• Repeat surgery

Primary outcomes:
measure: Leg pain
timeFrame: 1 hour after surgery
measure: Leg pain
timeFrame: 6 hours after surgery
measure: Leg pain
timeFrame: 12 hours after surgery
measure: Leg pain
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Ashkelon
country: Israel
facility: Barzilay University Medical Center
Study officials:
affiliation: Barzilai Medical Center
name: Ofer Gemer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.