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

B

Barzilai Medical Center

Status

Completed

Conditions

Stress Urinary Incontinence

Treatments

Drug: Marcaine 0.5 % Injectable Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT03479996
BRZ 0005-18 CTIL

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

Female

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

• Women undergoing TVT-O

Exclusion criteria

• Repeat surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

22 participants in 2 patient groups

Anesthetic
Experimental group
Treatment:
Drug: Marcaine 0.5 % Injectable Solution
Control
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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