Phase 4
Completed N=114
Trial Liposomal Bupivacaine Following Retropubic Suburethral Sling for Stress Urinary Incontinence
Urinary Incontinence, Stress
Source: ClinicalTrials.gov NCT02296099 ↗
Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Pain in the Morning — 9.5; 27.0 scores on a scale — p=0.014
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to determine if the administration of liposomal bupivacaine at the completion of a suburethral sling procedure will result in decreased postoperative pain compared to no injection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain in the Morning |
9.5; 27.0 | 0.014 sig |
| SECONDARY Pain Upon Discharge From Post-anesthesia Care Unit (PACU) |
1.0; 1.0 | — |
| SECONDARY Pain Upon Discharge From Same Day Surgery |
2.0; 4.0 | — |
| SECONDARY Pain at Four Hours After Discharge Home |
3.5; 13.0 | — |
| SECONDARY Total Narcotic Consumption |
11.50; 13.39 | — |
| SECONDARY Number of Participants Reporting 'Very Satisfied' at the 1 Week Postoperative Visit |
39; 45 | — |
Eligibility Criteria
Inclusion Criteria
- Adults greater than 18 years of age
- Planning for outpatient surgical treatment of stress urinary incontinence with placement of a retropubic 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, and/or 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
Data sourced from ClinicalTrials.gov (NCT02296099). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.