Pain
Conditions
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.
Detailed 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.
Interventions
DRUGPlacebo
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.
DRUGLiposomal 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.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) | 4 hours after being discharged home | To determine if liposomal bupivacaine administered at the completion of a transobturator suburethral sling will result in decreased postoperative pain compared to placebo. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Likert scale to rate their level of satisfaction with their postoperative pain control. | At 1 and 2 weeks postoperatively | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| VAS to rate their level of satisfaction with their postoperative pain control. | At 1 & 2 weeks postoperatively | 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. |
Countries
United States
Outcome results
None listed