Expired Study
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Cincinnati, Ohio 45220


Purpose:

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.


Study summary:

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.


Criteria:

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.


Study is Available At:


Original ID:

14-081


NCT ID:

NCT02591888


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

TriHealth Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Difficult to enroll; since a similar researc


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

18


Enrollment Type:

Actual


Overall Contact Information

Official Name:Catrina C Crisp, MD
Principal Investigator
TriHealth Inc.

Study Dates

Start Date:February 2015
Completion Date:December 2017
Completion Type:Actual
Primary Completion Date:March 2017
Primary Completion Type:Actual
Verification Date:January 2018
Last Changed Date:July 19, 2018
First Received Date:February 26, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Likert scale to rate their level of satisfaction with their postoperative pain control.
Time Frame:At 1 and 2 weeks postoperatively
Safety Issues:False
Description: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.
Outcome Type:Primary Outcome
Measure:Visual analog scale (VAS)
Time Frame:4 hours after being discharged home
Safety Issues:False
Description:To determine if liposomal bupivacaine administered at the completion of a transobturator suburethral sling will result in decreased postoperative pain compared to placebo.

Study Interventions

Intervention Type:Drug
Name:Placebo
Description: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.
Arm Name:Placebo
Other Name:Normal Saline
Intervention Type:Drug
Name:Liposomal bupivacaine
Description: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.
Arm Name:Liposomal bupivacaine
Other Name:Exparel

Study Arms

Study Arm Type:Active Comparator
Arm Name:Liposomal bupivacaine
Description:Subjects in this arm will received the drug - liposomal bupivacaine 30 ml.
Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Subjects in this arm will received the placebo - normal saline 30 mL.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:TriHealth Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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