Trial Outcomes & Findings for Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain (NCT NCT02959996)

NCT ID: NCT02959996

Last Updated: 2018-08-27

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 80 participants
• Primary outcome timeframe: at 48-hours post-operatively
• Results posted on: 2018-08-27

Participant Flow

40 patients enrolled in both groups, however 1 patient in the liposomal bupivacaine group was excluded after randomization.

Participant milestones

Measure	Placebo Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Overall Study STARTED	40	39
Overall Study COMPLETED	40	39
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain

Baseline characteristics by cohort

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=39 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision	Total n=79 Participants Total of all reporting groups
Age, Continuous	34.7 years STANDARD_DEVIATION 3.7 • n=5 Participants	35.6 years STANDARD_DEVIATION 4.2 • n=7 Participants	35.2 years STANDARD_DEVIATION 0.5 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	39 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants	34 Participants n=7 Participants	70 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
BMI, pre-pregnancy, kg/m2	27.6 kg/m2 STANDARD_DEVIATION 6.4 • n=5 Participants	26.2 kg/m2 STANDARD_DEVIATION 5.3 • n=7 Participants	26.9 kg/m2 STANDARD_DEVIATION 0.7 • n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=37 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Pain Score With Activity	3.5 units on a scale Interval 2.0 to 5.5	4 units on a scale Interval 2.0 to 5.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Placebo n=36 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=32 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Pain Score With Activity	3 units on a scale Interval 3.0 to 6.0	2.5 units on a scale Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 72-hours post-operatively

Total opioid use (in morphine equivalents)

Outcome measures

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=39 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Total Opioid Use (in Morphine Equivalents)	78.8 morphine milligram equivalents (MME) Interval 33.8 to 123.8	75 morphine milligram equivalents (MME) Interval 7.5 to 105.0

SECONDARY outcome

Timeframe: 48-hours post-operatively

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

Outcome measures

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=37 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Satisfaction With Post-operative Pain Control	9 units on a scale Interval 7.0 to 10.0	9 units on a scale Interval 8.0 to 10.0

SECONDARY outcome

Timeframe: 0 to 96 hours postoperatively

Postoperative hospital length of stay

Outcome measures

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=39 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Postoperative Hospital Length of Stay	3.5 days Standard Deviation 0.5	3.4 days Standard Deviation 1.0

SECONDARY outcome

Timeframe: 14 days postoperatively

Wound complication - separation, dehiscence, infection

Outcome measures

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=39 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Number of Patients With Wound Complication - Separation, Dehiscence, Infection	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 0-96 hours postoperatively

incisional rash, hives, anaphylaxis

Outcome measures

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=39 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Number of Patients With Allergic Reaction Attributable to Local Anesthestic	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.

Operative time of cesarean delivery

Outcome measures

Measure	Placebo n=40 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=39 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Operative Time of Cesarean Delivery	1.2 hours Interval 1.1 to 1.4	1.2 hours Interval 1.1 to 1.5

SECONDARY outcome

Timeframe: 6 weeks postpartum

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

Outcome measures

Measure	Placebo n=37 Participants Normal saline will be infiltrated Placebo: placebo injection in the Pfannenstiel incision	Intervention n=36 Participants Liposomal bupivacaine will be infiltrated Liposomal bupivacaine: liposomal bupivacaine injection in the Pfannenstiel incision
Patient Satisfaction With Pain Management at 6w Postpartum	35 Participants	33 Participants

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Malavika Prabhu

Massachussetts General Hospital

Phone: 6177249028

Email: mprabhu@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place