Trial Outcomes & Findings for Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy (NCT NCT02352922)

NCT ID: NCT02352922

Last Updated: 2020-10-01

Results Overview

Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 64 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2020-10-01

Participant Flow

Participant milestones

Measure	Liposomal Bupivacaine extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Overall Study STARTED	32	32
Overall Study COMPLETED	28	28
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy

Baseline characteristics by cohort

Measure	Liposomal Bupivacaine n=32 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=32 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl	Total n=64 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 8.6 • n=5 Participants	45.4 years STANDARD_DEVIATION 9.1 • n=7 Participants	45.19 years STANDARD_DEVIATION 8.86 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	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	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	18 Participants n=7 Participants	42 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
BMI	29 kg/m^2 n=5 Participants	27.6 kg/m^2 n=7 Participants	28.3 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=30 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=30 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1).	4.17 units on a scale Standard Deviation 2.2	4.97 units on a scale Standard Deviation 2.6

SECONDARY outcome

Timeframe: 2 hours post-op

numeric rating scale (0-10), mean and SD, where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=30 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=31 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
NRS Pain Score at 2 Hours	2.53 units on a scale Standard Deviation 2.53	2.74 units on a scale Standard Deviation 3.24

SECONDARY outcome

Timeframe: 4 hours post-op

Pain scale measured from 0-10, where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=30 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=31 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
NRS Pain Score at 4 Hours	3.87 Score on a scale Standard Deviation 2.86	3 Score on a scale Standard Deviation 2.95

SECONDARY outcome

Timeframe: 8 hours post-op

Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=30 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=30 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
NRS Pain Score at 8 Hours	3.77 Score on a scale Standard Deviation 2.75	3.67 Score on a scale Standard Deviation 3.01

SECONDARY outcome

Timeframe: 16 hours post-op

Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=29 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=29 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
NRS Pain Score at 16 Hours	3.1 score on a scale Standard Deviation 3.18	3.97 score on a scale Standard Deviation 2.76

SECONDARY outcome

Timeframe: 2 days post-op

Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=29 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=31 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
NRS Pain Score Post-op Day 2	3.34 score on a scale Standard Deviation 2.06	4.17 score on a scale Standard Deviation 2.16

SECONDARY outcome

Timeframe: 3 days post-op

Pain scale, where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=29 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=30 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
NRS Pain Score Post-op Day 3	2.79 score on a scale Standard Deviation 2.26	4.07 score on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: Post-Operative Day 14

Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

Outcome measures

Measure	Liposomal Bupivacaine n=28 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=28 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
NRS Pain Score Post-op Day 14	1.64 score on a scale Standard Deviation 2.58	2.07 score on a scale Standard Deviation 2.58

SECONDARY outcome

Timeframe: Post-Operative Day 2

The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes

Outcome measures

Measure	Liposomal Bupivacaine n=29 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=31 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Quality of Life as Measured by the Brief Pain Inventory (BPI)	4.09 score on a scale Standard Deviation 2.58	4.31 score on a scale Standard Deviation 1.99

SECONDARY outcome

Timeframe: Post-Operative Day 3

The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes

Outcome measures

Measure	Liposomal Bupivacaine n=29 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=30 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Quality of Life as Measured by the Brief Pain Inventory (BPI)	3.36 score on a scale Standard Deviation 2.71	3.94 score on a scale Standard Deviation 2.37

SECONDARY outcome

Timeframe: Post-Operative Day 14

at time of post-op visit The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes

Outcome measures

Measure	Liposomal Bupivacaine n=28 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=28 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Quality of Life as Measured by the Brief Pain Inventory (BPI)	1.74 score on a scale Standard Deviation 2.61	1.65 score on a scale Standard Deviation 1.93

SECONDARY outcome

Timeframe: 24 hours

Oral morphine equivalent of opioid use while in the hospital

Outcome measures

Measure	Liposomal Bupivacaine n=32 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=32 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Total Opioid Use Prior to Hospital Discharge	216 mg (oral morphine equivalents) Interval 75.0 to 810.0	266 mg (oral morphine equivalents) Interval 54.0 to 634.0

SECONDARY outcome

Timeframe: 72 hrs post-op

Total use of home opioids by pill count/ oral morphine equivalents

Outcome measures

Measure	Liposomal Bupivacaine n=29 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=30 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Total Opioid Use End of Post-op Day 3	320 mg (oral morphine equivalents) Interval 115.0 to 766.0	344 mg (oral morphine equivalents) Interval 84.0 to 784.0

SECONDARY outcome

Timeframe: Post-Operative Day 14

Total use of home opioids by pill count/ oral morphine equivalents

Outcome measures

Measure	Liposomal Bupivacaine n=27 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=28 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Total Opioid Use at Post-op Day 14	360 mg (oral morphine equivalents) Interval 115.0 to 1086.0	443 mg (oral morphine equivalents) Interval 84.0 to 1234.0

SECONDARY outcome

Timeframe: Post-Operative Day 14

Population: if a patient reported a particular adverse effect at more than one time point, the patient was counted only once. Patients may report more than one adverse effect. Analysis and percentages reflect only those with complaints of adverse effects.

Outcome measures

Measure	Liposomal Bupivacaine n=16 Participants extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	Bupivacaine HCl n=25 Participants short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Number of Participants With Adverse Events Dizziness	1 Participants	3 Participants
Number of Participants With Adverse Events Gas distension/bloated	5 Participants	9 Participants
Number of Participants With Adverse Events Constipation	5 Participants	2 Participants
Number of Participants With Adverse Events Nausea	4 Participants	6 Participants
Number of Participants With Adverse Events Headache	2 Participants	7 Participants
Number of Participants With Adverse Events Sore throat/cough	1 Participants	3 Participants

Adverse Events

Liposomal Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bupivacaine HCl

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

Dr. Kenneth I Barron

Center for Advanced Gynecology, PLLC

Phone: 5088876896

Email: kenneth.barron.md@gmail.com

Results disclosure agreements

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