NCT02959996

Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain

Completed Phase 2, PHASE3 Results posted Last updated 27 August 2018

What this trial tests

Phase 2, PHASE3 trial testing Liposomal bupivacaine in Pain, Postoperative in 80 participants. Completed in 3 November 2017.

Timeline

8 March 2017

Primary endpoint
25 September 2017

3 November 2017

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	8 March 2017
Primary completion	25 September 2017
Estimated completion	3 November 2017
Sites	1 location across United States

Drugs / interventions tested

• Liposomal bupivacaine — full drug profile →
• Placebo

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, female only, with Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pain Score With Activity Primary · at 48-hours post-operatively

Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39

Group	Value	95% CI
Placebo	3.5	2 – 5.5
Intervention	4	2 – 5

Pain Score With Activity Secondary · at 72 -hours post-operatively

Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment

Group	Value	95% CI
Placebo	3	3 – 6
Intervention	2.5	2 – 4

Total Opioid Use (in Morphine Equivalents) Secondary · 72-hours post-operatively

Total opioid use (in morphine equivalents)

Group	Value	95% CI
Placebo	78.8	33.8 – 123.8
Intervention	75	7.5 – 105

Satisfaction With Post-operative Pain Control Secondary · 48-hours post-operatively

PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied

Group	Value	95% CI
Placebo	9	7 – 10
Intervention	9	8 – 10

Postoperative Hospital Length of Stay Secondary · 0 to 96 hours postoperatively

Postoperative hospital length of stay

Group	Value	95% CI
Placebo	3.5	± 0.5
Intervention	3.4	± 1.0

Number of Patients With Wound Complication - Separation, Dehiscence, Infection Secondary · 14 days postoperatively

Wound complication - separation, dehiscence, infection

Group	Value	95% CI
Placebo	3
Intervention	1

Number of Patients With Allergic Reaction Attributable to Local Anesthestic Secondary · 0-96 hours postoperatively

incisional rash, hives, anaphylaxis

Group	Value	95% CI
Placebo	0
Intervention	0

Operative Time of Cesarean Delivery Secondary · Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.

Operative time of cesarean delivery

Group	Value	95% CI
Placebo	1.2	1.1 – 1.4
Intervention	1.2	1.1 – 1.5

Patient Satisfaction With Pain Management at 6w Postpartum Secondary · 6 weeks postpartum

Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used

Group	Value	95% CI
Placebo	35
Intervention	33

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial.
   Prabhu M, Clapp MA, McQuaid-Hanson E, Ona S, et al · · 2018 · cited 28× · PMID 29889750 · DOI 10.1097/aog.0000000000002649