Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement

Study Overview
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Brief Summary
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Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups. One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.

Detailed Description
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This is a prospective, comparative, randomized study. Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups. The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution. The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution. The postoperative pain will be compared between groups using a visual analog scale. The quality of recovery will be compared between the groups using the quality of recovery short form. Postoperative opioid consumption will be compared between the two groups.

Official Title
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Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Liposomal Bupivacaine
* Drug: Bupivacaine Hydrochloride and Lidocaine
* Procedure: Suburethral Sling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA physical status I-III Age >18 years Not Pregnant Able to give informed consent Electively chose surgical management of SUI with a suburethral sling Exclusion Criteria: Pregnant or nursing Allergy to amide anesthetics History of drug or alcohol abuse Severe cardiovascular, hepatic, renal disease or neurological impairment, Long-acting opioid within 3 days or any opioid use within 24 hours before surgery Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types Contraindication to: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAID), Hydrocodone, Oxycodone, Hydromorphone AND Morphine, Administration of an investigational drug within 30 days before this study Chronic pain syndromes Daily NSAID or opioid use Patients undergoing concomitant procedures

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liposomal Bupivacaine<br>20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling. | Drug: Liposomal Bupivacaine<br>* 20 mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars<br>* Other names: EXPAREL;Procedure: Suburethral Sling<br>* A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.<br>* Other names: Midurethral Sling;|
| Active Comparator: Bupivacaine Hydrochloride and Lidocaine<br>Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling. | Drug: Bupivacaine Hydrochloride and Lidocaine<br>* Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.<br>* Other names: Marcaine and Lidocaine;Procedure: Suburethral Sling<br>* A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.<br>* Other names: Midurethral Sling;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Day 1 Pain | Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm. This will be recorded by the patient prior to going to bed. | Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Second Stage PACU Postoperative Pain | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon admission to second stage PACU. | The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study. | 
| Postoperative Pain Upon Discharge | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon discharge from the hospital. | The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study. | 
| Postoperative Pain Four Hours After Discharge | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced. This will be recorded 4 hours after being discharged from the hospital. | Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. | 
| Night of Surgery Postoperative Pain | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on the night of surgery. | Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. | 
| Postoperative Days 2 through 7 Pain | Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on postop days 2-7. | Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. | 
| Preoperative Quality of Recovery | Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery. | The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study. | 
| Postoperative Days 1, 7 and 14 Quality of Recovery | Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14. | The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. | 
| Postoperative Narcotic Consumption | The total amount of narcotic taken the night of surgery and each day thereafter through postoperative day seven will be recorded each night prior to going to bed. | The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Anesthetic Effects, Mid-urethral sling