Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic
Primary Purpose
Stress Urinary Incontinence
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Marcaine 0.5 % Injectable Solution
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
• Women undergoing TVT-O
Exclusion Criteria:
• Repeat surgery
Sites / Locations
- Barzilay University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Anesthetic
Control
Arm Description
Outcomes
Primary Outcome Measures
Leg pain
VAS score
Leg pain
VAS score
Leg pain
VAS score
Leg pain
VAS score
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03479996
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
June 22, 2020 (Actual)
Study Completion Date
June 22, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barzilai Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anesthetic
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Marcaine 0.5 % Injectable Solution
Intervention Description
Intra -operative injection into obturator membrane
Primary Outcome Measure Information:
Title
Leg pain
Description
VAS score
Time Frame
1 hour after surgery
Title
Leg pain
Description
VAS score
Time Frame
6 hours after surgery
Title
Leg pain
Description
VAS score
Time Frame
12 hours after surgery
Title
Leg pain
Description
VAS score
Time Frame
24 hours after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
• Women undergoing TVT-O
Exclusion Criteria:
• Repeat surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ofer Gemer, Prof.
Organizational Affiliation
Barzilai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barzilay University Medical Center
City
Ashkelon
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17362484
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. Erratum In: BJOG. 2007 Oct;114(10):1311.
Results Reference
background
PubMed Identifier
22336228
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.
Results Reference
background
PubMed Identifier
22752013
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.
Results Reference
background
PubMed Identifier
18769847
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.
Results Reference
background
PubMed Identifier
24599566
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.
Results Reference
background
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Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic
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