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

Not Applicable

Completed

• Conditions: Stress Urinary Incontinence
• Interventions: Drug: Marcaine 0.5 % Injectable Solution

• Registration Number: NCT03479996
• Lead Sponsor: Barzilai Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-03-21
• Study First Submitted QC: 2018-03-21
• Study First Posted: 2018-03-27
• Study Start: 2018-11-13
• Primary Completion: 2020-06-22
• Study Completion: 2020-06-22
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Women undergoing TVT-O

Exclusion Criteria

• Repeat surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anesthetic	Marcaine 0.5 % Injectable Solution	-

Primary Outcome Measures

Name	Time	Method
Leg pain	24 hours after surgery	VAS score

Trial Locations

Locations (1)

Barzilay University Medical Center; 🇮🇱 Ashkelon, Israel