Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic

NCT03479996 | Completed

• 1 other identifier: BRZ 0005-18 CTIL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress Urinary Incontinence

Outcome Measures

Primary Outcomes (4)

• Leg pain

  VAS score

  1 hour after surgery

• Leg pain

  VAS score

  6 hours after surgery

• Leg pain

  VAS score

  12 hours after surgery

• Leg pain

  VAS score

  24 hours after surgery

Study Arms (2)

Anesthetic

EXPERIMENTAL

Drug: Marcaine 0.5 % Injectable Solution

Control

NO INTERVENTION

Interventions

Marcaine 0.5 % Injectable Solution DRUG

Intra -operative injection into obturator membrane

Anesthetic

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing TVT-O

You may not qualify if:

• Repeat surgery

Sponsors & Collaborators

• Barzilai Medical Center: lead

Study Sites (1)

Barzilay University Medical Center

Ashkelon, Israel

Location

Related Publications (6)

• 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.

  PMID: 17362484 BACKGROUND

• 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.

  PMID: 22336228 BACKGROUND

• 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.

  PMID: 22752013 BACKGROUND

• 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.

  PMID: 18769847 BACKGROUND

• 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.

  PMID: 24599566 BACKGROUND

• 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.

  PMID: 38743075 DERIVED

MeSH Terms

Conditions

Urinary Incontinence, Stress

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ofer Gemer, Prof.

  Barzilai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of gynecological surgery, BMC

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: March 27, 2018
• Study Start: November 13, 2018
• Primary Completion: June 22, 2020
• Study Completion: June 22, 2020
• Last Updated: July 14, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)