Trial Outcomes & Findings for Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy (NCT NCT05157841)

Last Updated: 2025-06-26

Results Overview

The numeric rating scale pain intensity scores ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 96 hours post-surgery. For each subject, the area under the curve was derived using the trapezoidal rule on the pain scores adjusted for opioid pain medication using the observed and imputed values. Area under the curve started with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 96 hours post-surgery. Pain scores were taken at 5 interval point 0 hours, 24 hours, 48 hours, 72 hours, and 96 hours. There were also unscheduled pain scores measured before opioid consumption also included in the area under the curve calculation. The area under the curve ranged from 0 to 960. Higher scores represent a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

185 participants

Primary outcome timeframe

0- 96 hours post-surgery

Results posted on

2025-06-26

Participant Flow

Participants were recruited based on physician referral at 6 sites between February 2022 and April 2022 for Part A and between April 2022 and July 2022 for Part B. The first participant was enrolled on February 15, 2022 and the last participant was enrolled on July 18, 2022.

Of 452 screened participants, 185 met inclusion criteria and were randomized to treatment in Part A (66 participants) or Part B (119 participants). Overall results are presented per treatment arm

Participant milestones

Participant milestones
Measure	EXPAREL 266 mg Arm subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	EXPAREL 133 mg Arm subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Bupivacaine HCl Arm Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine hydrochloric acid (HCl) mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
Part A (14 Days) STARTED	22	22	22
Part A (14 Days) COMPLETED	21	21	19
Part A (14 Days) NOT COMPLETED	1	1	3
Part B (14 Days) STARTED	0	59	60
Part B (14 Days) COMPLETED	0	59	60
Part B (14 Days) NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	EXPAREL 266 mg Arm subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	EXPAREL 133 mg Arm subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Bupivacaine HCl Arm Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine hydrochloric acid (HCl) mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
Part A (14 Days) Withdrawal by Subject	0	1	2
Part A (14 Days) Adverse Event	1	0	0
Part A (14 Days) Failure to meet continuation criteria	0	0	1

Baseline Characteristics

One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: EXPAREL 266 mg Arm n=22 Participants subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 Participants subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 Participants Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl	Total n=185 Participants Total of all reporting groups
Age, Continuous	48.36 years STANDARD_DEVIATION 10.896 • n=22 Participants	50.15 years STANDARD_DEVIATION 12.823 • n=81 Participants	47.24 years STANDARD_DEVIATION 11.950 • n=82 Participants	48.65 years STANDARD_DEVIATION 12.239 • n=185 Participants
Age, Customized <45 Years	6 Participants n=22 Participants	28 Participants n=81 Participants	30 Participants n=82 Participants	64 Participants n=185 Participants
Age, Customized Between 45 and 65 years	16 Participants n=22 Participants	45 Participants n=81 Participants	47 Participants n=82 Participants	108 Participants n=185 Participants
Age, Customized >=65 years	0 Participants n=22 Participants	8 Participants n=81 Participants	5 Participants n=82 Participants	13 Participants n=185 Participants
Sex: Female, Male Female	21 Participants n=22 Participants	74 Participants n=81 Participants	68 Participants n=82 Participants	163 Participants n=185 Participants
Sex: Female, Male Male	1 Participants n=22 Participants	7 Participants n=81 Participants	14 Participants n=82 Participants	22 Participants n=185 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=22 Participants	26 Participants n=81 Participants	32 Participants n=82 Participants	68 Participants n=185 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=22 Participants	55 Participants n=81 Participants	50 Participants n=82 Participants	117 Participants n=185 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants	0 Participants n=81 Participants	0 Participants n=82 Participants	0 Participants n=185 Participants
Race/Ethnicity, Customized White	16 Participants n=22 Participants	47 Participants n=81 Participants	49 Participants n=82 Participants	112 Participants n=185 Participants
Race/Ethnicity, Customized Black/African American	4 Participants n=22 Participants	25 Participants n=81 Participants	28 Participants n=82 Participants	57 Participants n=185 Participants
Race/Ethnicity, Customized Other	2 Participants n=22 Participants	9 Participants n=81 Participants	5 Participants n=82 Participants	16 Participants n=185 Participants
Region of Enrollment United States	22 participants n=22 Participants	81 participants n=81 Participants	82 participants n=82 Participants	185 participants n=185 Participants
ASA classification ASA 1	14 Participants n=22 Participants	39 Participants n=81 Participants	54 Participants n=82 Participants	107 Participants n=185 Participants
ASA classification ASA 2	8 Participants n=22 Participants	42 Participants n=81 Participants	28 Participants n=82 Participants	78 Participants n=185 Participants
Body Mass Index <25 kg/m^2	8 Participants n=22 Participants	21 Participants n=81 Participants	24 Participants n=82 Participants	53 Participants n=185 Participants
Body Mass Index 25 to <30 kg/m^2	10 Participants n=22 Participants	27 Participants n=81 Participants	32 Participants n=82 Participants	69 Participants n=185 Participants
Body Mass Index ≥30 kg/m^2	4 Participants n=22 Participants	33 Participants n=81 Participants	26 Participants n=82 Participants	63 Participants n=185 Participants
Worst pain intensity (NRS)	5.4 units on a scale STANDARD_DEVIATION 3.00 • n=22 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.	5.2 units on a scale STANDARD_DEVIATION 2.71 • n=81 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.	5.7 units on a scale STANDARD_DEVIATION 2.59 • n=81 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.	5.5 units on a scale STANDARD_DEVIATION 2.69 • n=184 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.
Average pain intensity (NRS)	3.9 units on a scale STANDARD_DEVIATION 2.23 • n=22 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.	3.4 units on a scale STANDARD_DEVIATION 2.10 • n=81 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.	3.8 units on a scale STANDARD_DEVIATION 2.33 • n=81 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.	3.7 units on a scale STANDARD_DEVIATION 2.22 • n=184 Participants • One participant in the Bupivacaine HCl arm (Part A) discontinued from the study due to an adverse event on Day 1.

PRIMARY outcome

Timeframe: 0- 96 hours post-surgery

Population: The analysis was performed on the efficacy analysis set which included all participants in the safety analysis set who underwent the planned surgery and had at least one post-drug administration NRS pain assessment.

Outcome measures

Outcome measures
Measure	Part A: EXPAREL 266 mg Arm n=22 Participants subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 Participants subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 Participants Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
NRS Pain Scores Through 96 Hours Post-surgery	342.3 units on a scale*hours Standard Deviation 265.35	201.3 units on a scale*hours Standard Deviation 180.05	377.4 units on a scale*hours Standard Deviation 188.60

SECONDARY outcome

Timeframe: 0 to 96 hours post-surgery

Total postsurgical opioid consumption in oral morphine equivalents (OMED) from 0 to 96 hours post-surgery

Outcome measures

Outcome measures
Measure	Part A: EXPAREL 266 mg Arm n=22 Participants subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 Participants subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 Participants Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
Postsurgical Opioid Consumption Through 96 Hours Post-surgery	32.68 milligrams oral morphine equivalents Geometric Coefficient of Variation 96.768	15.41 milligrams oral morphine equivalents Geometric Coefficient of Variation 126.781	41.62 milligrams oral morphine equivalents Geometric Coefficient of Variation 83.925

SECONDARY outcome

Timeframe: 0 to 96 hours post-surgery

Percentage of opioid-free subjects through 96 hours

Outcome measures

Outcome measures
Measure	Part A: EXPAREL 266 mg Arm n=22 Participants subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 Participants subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 Participants Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
Opioid-free Subjects Through 96 Hours Post-surgery	4.5 percentage of participants	33.3 percentage of participants	9.8 percentage of participants

SECONDARY outcome

Timeframe: 0 to 96 hours post-surgery

Time to first opioid consumption post-surgery

Outcome measures

Outcome measures
Measure	Part A: EXPAREL 266 mg Arm n=22 Participants subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 Participants subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 Participants Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
First Opioid Consumption Post-surgery	16.06 hours Interval 12.32 to 20.57	20.27 hours Interval 17.13 to 29.98	20.68 hours Interval 19.28 to 24.4

SECONDARY outcome

Timeframe: 0-24 hours, 24-48 hours, 48-72 hours, and 72-96 hours post-surgery

Population: The number analyzed in one or more rows differs from overall number analyzed due to participant discontinuation from the study in Part A.

Worst and average NRS pain intensity scores at 24h, 48h, 72h, and 96h from the end of surgery Worst and average pain intensity scores on a numeric rating scale ranging from 0 to 10, where 0 equals no pain and 10 equals the worst possible pain, from 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, and 72 to 96 hours. Mean scores at each timepoint are provided. The total range is 0 (no pain) to 10 (worst possible pain). Higher values on the scale represent worse outcome.

Outcome measures

Outcome measures
Measure	Part A: EXPAREL 266 mg Arm n=22 Participants subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 Participants subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 Participants Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
NRS Pain Scores Post-surgery Worst pain at 96 hours	4.4 units on a scale Standard Deviation 3.68	2.8 units on a scale Standard Deviation 2.84	5.1 units on a scale Standard Deviation 2.81
NRS Pain Scores Post-surgery Average pain at 48 hours	3.9 units on a scale Standard Deviation 2.74	2.9 units on a scale Standard Deviation 2.33	4.8 units on a scale Standard Deviation 2.01
NRS Pain Scores Post-surgery Worst pain at 24 hours	6.0 units on a scale Standard Deviation 3.18	4.4 units on a scale Standard Deviation 3.13	5.3 units on a scale Standard Deviation 3.06
NRS Pain Scores Post-surgery Worst pain at 48 hours	6.1 units on a scale Standard Deviation 2.49	4.4 units on a scale Standard Deviation 3.14	7.3 units on a scale Standard Deviation 2.22
NRS Pain Scores Post-surgery Worst pain at 72 hours	4.3 units on a scale Standard Deviation 3.55	2.7 units on a scale Standard Deviation 2.87	6.1 units on a scale Standard Deviation 2.69
NRS Pain Scores Post-surgery Average pain at 24 hours	4.7 units on a scale Standard Deviation 2.60	2.8 units on a scale Standard Deviation 2.32	3.0 units on a scale Standard Deviation 2.58
NRS Pain Scores Post-surgery Average pain at 72 hours	3.5 units on a scale Standard Deviation 3.19	1.8 units on a scale Standard Deviation 2.05	4.1 units on a scale Standard Deviation 2.19
NRS Pain Scores Post-surgery Average pain at 96 hours	3.2 units on a scale Standard Deviation 3.14	1.7 units on a scale Standard Deviation 2.03	3.3 units on a scale Standard Deviation 2.10

Adverse Events

Part A: EXPAREL 266 mg Arm

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Part A + B: EXPAREL 133 mg Arm

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Part A + B: Bupivacaine HCl Arm

Serious events: 1 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: EXPAREL 266 mg Arm n=22 participants at risk subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 participants at risk subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 participants at risk Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
Cardiac disorders Atrioventricular block second degree	0.00% 0/22 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/81 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	1.2% 1/82 • Number of events 1 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
General disorders Pyrexia	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/81 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/82 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
Vascular disorders Hypertension	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/81 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/82 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.

Other adverse events

Other adverse events
Measure	Part A: EXPAREL 266 mg Arm n=22 participants at risk subjects randomized to this treatment arm received 20 mL (266 mg) EXPAREL mixed with 10 mL saline Bupivacaine liposome injectable suspension 266 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 266 mg	Part A + B: EXPAREL 133 mg Arm n=81 participants at risk subjects randomized to this treatment arm received 10 mL (133 mg) EXPAREL mixed with 20 mL saline Bupivacaine liposome injectable suspension 133 mg: Sciatic nerve block in the popliteal fossa with EXPAREL 133 mg	Part A + B: Bupivacaine HCl Arm n=82 participants at risk Subjects randomized to this treatment arm received 20 mL (50 mg) 0.25% bupivacaine HCl mixed with 10 mL saline Bupivacaine HCl: Sciatic nerve block in the popliteal fossa with Bupivacaine HCl
Gastrointestinal disorders Nausea	40.9% 9/22 • Number of events 11 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	16.0% 13/81 • Number of events 14 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	23.2% 19/82 • Number of events 19 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
Gastrointestinal disorders Constipation	13.6% 3/22 • Number of events 3 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	12.3% 10/81 • Number of events 10 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	19.5% 16/82 • Number of events 16 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
Gastrointestinal disorders Vomiting	22.7% 5/22 • Number of events 5 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	4.9% 4/81 • Number of events 6 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	8.5% 7/82 • Number of events 7 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
Nervous system disorders Headache	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	9.9% 8/81 • Number of events 10 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	4.9% 4/82 • Number of events 4 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
Skin and subcutaneous tissue disorders Pruritus	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	7.4% 6/81 • Number of events 6 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	6.1% 5/82 • Number of events 5 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
Gastrointestinal disorders Dyspepsia	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	2.5% 2/81 • Number of events 2 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/82 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.
Nervous system disorders Hypoaesthesia	4.5% 1/22 • Number of events 1 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/81 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.	0.00% 0/82 • Treatment-emergent adverse events were collected from the date and time on or after the start date and time of study drug administration through post-operative Day 14 Participants were expected to volunteer information about adverse events that they experienced. In addition, the investigator or designee questioned the patient at each scheduled time point/visit about adverse events and recorded these as well as other adverse events at the time point/visit. Participants experiencing the same adverse events more than once were counted only once at each summary level.

Additional Information

Pacira Medical Information

Pacira Pharmaceuticals, Inc.

Phone: 1-855-793-9727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Disclosure restrictions include: * PIs or any other party are not allowed to publish any publication for a period of twelve months following completion of the clinical study report for the trial. * PIs or any other party shall submit a proposal to the Sponsor for approval to obtain trial results that have not been previously made public and any publication, abstract or paper or other written materials to the trial shall be submitted to the Sponsor at least 60 days prior to submission.
Publication restrictions are in place

Restriction type: OTHER