Ignite Creation Date:
2024-05-06 @ 11:15 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03479996
Status:
COMPLETED
Last Update Posted:
2020-07-14
First Post:
2018-03-21
Brief Title:
Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation TVT-O With or Without Local Anesthetic
Sponsor:
Barzilai Medical Center
Organization:
Barzilai Medical Center
Study Overview
Official Title:
Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation TVT-O With or Without Local Anesthetic
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 5 mg mL Injectionopposite 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 161224 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
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 05 5 mg mL Injectionopposite 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 161224 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None