Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling

NCT02591888 | Terminated Phase 4 DMC

• 1 other identifier: 14-081
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Liposomal bupivacaine or placebo will be administered at the end of a transobturator midurethral sling to determine if there is a difference in a patient's perceived postoperative pain.

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  To determine if liposomal bupivacaine administered at the completion of a transobturator suburethral sling will result in decreased postoperative pain compared to placebo.

  4 hours after being discharged home

Secondary Outcomes (1)

• Likert scale to rate their level of satisfaction with their postoperative pain control.

  At 1 and 2 weeks postoperatively

Other Outcomes (1)

• VAS to rate their level of satisfaction with their postoperative pain control.

  At 1 & 2 weeks postoperatively

Study Arms (2)

Liposomal bupivacaine

ACTIVE COMPARATOR

Subjects in this arm will received the drug - liposomal bupivacaine 30 ml.

Drug: Liposomal bupivacaine

Placebo

PLACEBO COMPARATOR

Subjects in this arm will received the placebo - normal saline 30 mL.

Drug: Placebo

Interventions

Placebo DRUG

At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of normal saline injected.

Also known as: Normal Saline

Placebo

Liposomal bupivacaine DRUG

At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of dilutional liposomal bupivacaine injected.

Also known as: Exparel

Liposomal bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \> 18 years of age
• Planning for outpatient surgical treatment of SUI with placement of a transobturator suburethral sling under general anesthesia

You may not qualify if:

• Pregnant or nursing
• Allergy to bupivacaine
• History of drug/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
• Contraindication to:
• acetaminophen
• oxycodone
• non-steroidal anti-inflammatory drugs (NSAID)
• Administration of an investigational drug within 30 days before study
• Chronic pain syndromes
• Daily NSAID/opioid use
• Patients having concomitant procedures or not undergoing general anesthesia
• Patients who require a concomitant anterior repair or urethrocele repair will not be excluded as this requires the same dissection in the anterior vaginal wall.

Sponsors & Collaborators

• TriHealth Inc.: lead

Study Sites (1)

TriHealth

Cincinnati, Ohio, 45220, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Catrina C Crisp, MD

  TriHealth Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: October 30, 2015
• Study Start: February 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 23, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)