Clinical trial NCT02875015: Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement
Official title: Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Anesthetics
Anesthetic Effects
Mid-urethral sling
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 57
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Day 1 Pain
timeFrame: 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 outcomes:
measure: Second Stage PACU Postoperative Pain
timeFrame: 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.
measure: Postoperative Pain Upon Discharge
timeFrame: 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.
measure: Postoperative Pain Four Hours After Discharge
timeFrame: 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.
measure: Night of Surgery Postoperative Pain
timeFrame: 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.
measure: Postoperative Days 2 through 7 Pain
timeFrame: 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.
measure: Preoperative Quality of Recovery
timeFrame: 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.
measure: Postoperative Days 1, 7 and 14 Quality of Recovery
timeFrame: 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.
measure: Postoperative Narcotic Consumption
timeFrame: 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.
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Morrristown Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlool Medical Center
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Charbel Salamon, MD
role: PRINCIPAL_INVESTIGATOR
References: