Phase 4
Completed N=72
Extended Release Local Anesthetic for Postsurgical Pain After Posterior Colporrhaphy and Perineorrhaphy
Source: ClinicalTrials.gov NCT03875664 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
May 2020
Primary outcomePrimary: Postoperative Pain — 1.9; 1.3; 2.0; 1.9 mm
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 specific aim of this randomized double-blind clinical trial is to evaluate the effect of intraoperative infiltration of liposomal bupivacaine at the time of posterior colporrhaphy and/or perineorrhaphy on postsurgical pain scores during the first 72 hours after surgery as measured by visual analog scales (VAS) for patients undergoing surgery for pelvic organ prolapse. Study subjects are randomized to 30 mL of liposomal bupivacaine versus 30 mL of injectable normal saline administered in a standardized technique into the posterior vaginal compartment at the time of posterior repair and/or perineorrhaphy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain |
1.9; 1.3; 2.0; 1.9; 2.9; 2.5 | — |
| SECONDARY Number of Participants Reporting Satisfaction With Pain Control |
32; 33 | — |
| SECONDARY Time to First Opioid Administration |
89.5; 68 | — |
| SECONDARY Total Opioid Administration |
37.5; 37.5 | — |
| SECONDARY Number of Antiemetic Doses Required Per Participant While Inpatient |
2; 3 | — |
| SECONDARY Hospital Length of Stay |
21.9; 24 | — |
| SECONDARY Length of Stay in Post-anesthesia Care Unit (PACU) |
100; 93 | — |
| SECONDARY Number of Participants Who Had a Bowel Movement Within the First 3 Postoperative Days |
22; 23 | — |
| SECONDARY Voiding Trial Failures |
15; 19 | — |
| SECONDARY Number of Patients With Adverse Events |
6; 11 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria
- English-speaking women ages 18 and older undergoing posterior repair and/or perineorrhaphy at our institution for pelvic organ prolapse
Exclusion Criteria
- Planned regional anesthesia
- Allergy or contraindication to bupivacaine
- Allergy or contraindication to opioids
- Allergy or contraindication to non-steroidal medications
- Planned laparotomy
- Chronic pain diagnosis and/or chronic narcotic use
Data sourced from ClinicalTrials.gov (NCT03875664). 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.