Phase 3
N=79
Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT02959996 ↗Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcome: Primary: Pain Score With Activity — 3.5; 4 units on a scale — p=0.72
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Liposomal bupivacaine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score With Activity |
3; 2.5 | .14 |
| SECONDARY Pain Score With Activity |
3; 2.5 | .14 |
| SECONDARY Total Opioid Use (in Morphine Equivalents) |
78.8; 75 | 0.54 |
| SECONDARY Satisfaction With Post-operative Pain Control |
9; 9 | — |
| SECONDARY Postoperative Hospital Length of Stay |
3.5; 3.4 | — |
| SECONDARY Number of Patients With Wound Complication - Separation, Dehiscence, Infection |
3; 1 | — |
| SECONDARY Number of Patients With Allergic Reaction Attributable to Local Anesthestic |
0; 0 | — |
| SECONDARY Operative Time of Cesarean Delivery |
1.2; 1.2 | — |
| SECONDARY Patient Satisfaction With Pain Management at 6w Postpartum |
35; 33 | — |
Summary
This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the time of cesarean delivery may decrease post-operative pain scores.
Eligibility Criteria
Inclusion Criteria
- Scheduled cesarean delivery via Pfannenstiel incision;
- Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.
Exclusion Criteria
- Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
- Contraindication to neuraxial anesthetic;
- Allergy to local anesthetic;
- Planned general anesthetic.
Data sourced from ClinicalTrials.gov (NCT02959996). 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.