Randomized Control Trial to Assess Postoperative Pain After Sling Placement

Study Overview
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Brief Summary
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There are many ways to perform a suprapubic approach pubovaginal sling. Some surgeons inject local pain medical into the retropubic space before placing the sling, others do not. This study is to determine if injection of local pain medication into the retropubic space before placing a mid-urethral sling for urinary stress incontinence results in lower postoperative pain scores, lower use of postoperative narcotic medication and lower rates of urinary retention.

Detailed Description
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To evaluate if an injection in the retropubic space with a local acting anesthetic, Marcaine, (bupivacaine) at the time of mid-urethral sling placement will improve patients' reported post operative pain and decrease the use of narcotic pain medication. This study will include all female patients age 18 and older who will undergo a mid-urethral sling with or without anterior repair for the treatment of urinary stress incontinence by a member of the Division of Urogynecology and Reconstructive Pelvic Surgery who consent to be in the study. Once patients have consented to participate in the study they will be randomized into two groups. One group will have the mid-urethral sling placed in the usual fashion with no injection of local anesthetic. The other group will have the mid-urethral sling placed after the retropubic space has been infiltrated with local anesthetic as previously described in the literature. Pain will be assessed with the use of a Visual Analog Scale during the hospitalization and the use of narcotic pain medication will be assessed during recovery and overnight in the hospital. Patients will be asked to record how often and what type of pain medication they use. Patients will also be asked to keep a log of their urination if they are discharged home with self catheterization. They will be asked to mail in their pain medication log and voiding diary (if needed) at a two-week post-operative. Outcomes will then be compared.

Official Title
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Injection of 0.125% Marcaine During Mid-Urethral Sling Placement for Pain Relief: A Randomized Control Trial

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: 0.125% Marcaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any female patient, age 18 or older, who elects to have a mid-urethral sling with or without an anterior or posterior repair at the University of North Carolina Hospitals by a member of the Division of Urogynecology. Exclusion Criteria: Any patient with a chronic pain syndrome, a contraindication to nonsteroidal anti-inflammatory drugs (NSAIDs) such as liver disease, abnormal coagulation, esophageal disorders or peptic ulcers or where pain evaluation is unreliable because of neurological disease and those on treatment with steroids/NSAIDs/opioids prior to surgery. Also excluded will be any patient who is having any other reconstructive pelvic surgery concomitantly or would require the placement of a suprapubic catheter. Patients electing to have their surgery with regional anesthesia, such as an epidural or spinal will be excluded. All minors, decisional impaired people, nursing mothers and non-English speaking people will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients randomized to this arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach. | Drug: 0.125% Marcaine<br>* Patients randomized to the intervention arm will receive 60 cc of 0.125% Marcaine injected into the retropubic space along the tract that the suprapubic mid-urethral trocar will follow (one on each side) for a total of 120 cc of 0.125% Marcaine, prior to the placement of the mid-urethral sling via the suprapubic approach.<br>* Other names: 0.125% Bupivacaine;|
| No Intervention: 2<br>Patients assigned to this arm will have the mid-urethral sling placed via the suprapubic approach in the standard fashion with no injection of Marcaine into the retropubic space. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Postoperative Pain Using a Visual Analog Scale at 2 Hours. | At approximately two hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever. | 2 hours postoperative from mid-urethral sling placement | 
| Difference in Postoperative Pain Using a Visual Analog Scale at 6 Hours. | At approximately six hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever. | 6 hours postoperative from mid-urethral sling placement | 
| Difference in Postoperative Pain Using a Visual Analog Scale at 24 Hours. | At approximately twenty-four hours postoperatively patients completed a visual analog scale (VAS), which was a 10-cm numeric scale on which 0 represented no pain and 10 represented the worst pain ever. | 24 hours postoperative from mid-urethral sling placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital Medication Amounts | Secondary outcome included differences in amount of pain medication used in the hospital. This was assessed by comparing the number of pills of oral narcotics the patient took while hospitalized. | From surgery until discharge, average | 
| Difference in Successful Voiding Trial Prior to Discharge Following Placement of Mid-urethral Sling Via the Suprapubic Approach. | Prior to discharge, patients underwent voiding trials. At our institution, in order to pass the voiding trial, they must void at least 200 cc spontaneously and have less than 100 cc as a post void residual two times in a row. | From after surgery to discharge from hospital. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mid-urethral sling, pubovaginal sling, postoperative pain, visual analog scale, suprapubic approach, SPARC sling