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

Pain Clinical Trial

Official title:

The Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling for Stress Urinary Incontinence: A Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02591888
• Other study ID #: 14-081
• Status: Terminated
• Phase: Phase 4
• Start date: February 2015
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: TriHealth Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The investigators aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain from placement of transobturator slings for the treatment of stress urinary incontinence.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults > 18 years of age

• Planning for outpatient surgical treatment of SUI with placement of a transobturator suburethral sling under general anesthesia

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo
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.
• Liposomal bupivacaine
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.

Locations

Country	Name	City	State
United States	TriHealth	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	VAS to rate their level of satisfaction with their postoperative pain control.	To assess the amount of oral narcotic required for pain control following administration of liposomal bupivacaine or placebo at the completion of a transobturator sling procedure.	At 1 & 2 weeks postoperatively
Primary	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	Likert scale to rate their level of satisfaction with their postoperative pain control.	To assess the amount of oral narcotic required for pain control following administration of liposomal bupivacaine or placebo at the completion of a transobturator sling procedure.	At 1 and 2 weeks postoperatively