Trial Outcomes & Findings for Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries (NCT NCT03927911)

NCT ID: NCT03927911

Last Updated: 2021-11-09

Results Overview

Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

0-72 hours

Results posted on

2021-11-09

Participant Flow

Subject might be excluded from the study prior to study drug infiltration if one of the following criteria during the surgical procedure is met: 1. Unable to place planned surgical instrumentation 2. Poor fixation at the time of surgical instrumentation

Participant milestones

Participant milestones
Measure	Cohort 1 Control Group Standard of Care	Cohort 2 Control Group Standard of Care	Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 3 Control Group Standard of Care
Overall Study STARTED	17	3	13	32
Overall Study COMPLETED	15	1	13	25
Overall Study NOT COMPLETED	2	2	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 Control Group Standard of Care	Cohort 2 Control Group Standard of Care	Cohort 3 Control Group Standard of Care
Overall Study problems with eDiary	1	1	4
Overall Study Adverse Event	0	0	1
Overall Study not treated -study terminated by sponsor	1	0	0
Overall Study Surgery cancelled	0	1	1
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1:Open or Mini-open Surgical Technique Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 1 Control Group n=17 Participants Standard of Care	Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort) Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 2 Control Group n=3 Participants Standard of Care	Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) n=13 Participants Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 3 Control Group n=32 Participants Standard of Care	Total n=65 Participants Total of all reporting groups
Age, Continuous	—	60.94 years n=7 Participants	—	56 years n=4 Participants	52.38 years n=21 Participants	52.66 years n=10 Participants	55.495 years n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	8 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants	11 Participants n=10 Participants	28 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	21 Participants n=10 Participants	37 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	16 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	12 Participants n=21 Participants	27 Participants n=10 Participants	58 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	7 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	—	1 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) White	—	15 Participants n=7 Participants	—	3 Participants n=4 Participants	12 Participants n=21 Participants	29 Participants n=10 Participants	59 Participants n=115 Participants
Race (NIH/OMB) More than one race	—	0 Participants n=7 Participants	—	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	—	1 Participants n=7 Participants	—	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	4 Participants n=115 Participants
Region of Enrollment United States	—	17 participants n=7 Participants	—	3 participants n=4 Participants	13 participants n=21 Participants	32 participants n=10 Participants	65 participants n=115 Participants

PRIMARY outcome

Timeframe: 0-72 hours

Population: Trial was terminated, not all arms had participants enrolled.

Post-surgical opioid consumption in mg MED PO from 0 hours (end of surgery) to 72 hours postsurgery

Outcome measures

Outcome measures
Measure	Cohort 1:Open or Mini-open Surgical Technique Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 1 Control Group n=16 Participants Standard of Care	Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort) Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 2 Control Group n=2 Participants Standard of Care	Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) n=13 Participants Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 3 Control Group n=30 Participants Standard of Care
Post-surgical Opioid Consumption in mg MED PO (0-72 Hours)	—	90.7 MED, mg Standard Deviation 96.91	—	56.8 MED, mg Standard Deviation 5.30	51.6 MED, mg Standard Deviation 60.98	83.6 MED, mg Standard Deviation 109.84

SECONDARY outcome

Timeframe: 0-14 days after surgery

Population: Trial was terminated, not all arms had participants enrolled.

Post-surgical opioid consumption in mg MED PO at 14 days after surgery

Outcome measures

Outcome measures
Measure	Cohort 1:Open or Mini-open Surgical Technique Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 1 Control Group n=16 Participants Standard of Care	Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort) Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 2 Control Group n=2 Participants Standard of Care	Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) n=13 Participants Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 3 Control Group n=30 Participants Standard of Care
Post-surgical Opioid Consumption in mg MED PO at 14 Days After Surgery	—	279 MED, mg Standard Deviation 330.66	—	330.8 MED, mg Standard Deviation 42.78	158.4 MED, mg Standard Deviation 242.71	187.7 MED, mg Standard Deviation 252.40

SECONDARY outcome

Timeframe: 0-72 hours

Population: Trial was terminated, not all arms had participants enrolled.

Time to first opioid rescue through 72 hours or discharge.

Outcome measures

Outcome measures
Measure	Cohort 1:Open or Mini-open Surgical Technique Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 1 Control Group n=16 Participants Standard of Care	Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort) Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 2 Control Group n=2 Participants Standard of Care	Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) n=13 Participants Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 3 Control Group n=30 Participants Standard of Care
Time to First Opioid Rescue Through 72 Hours or Discharge.	—	0.82 hours Interval 0.58 to 8.02	—	0.36 hours Interval 0.03 to 0.68	3.07 hours Interval 0.6 to 25.1	0.95 hours Interval 0.83 to 1.52

Adverse Events

Cohort 1:Open or Mini-open Surgical Technique

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 1 Control Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 2 Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort)

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Cohort 3 Control Group

Serious events: 1 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1:Open or Mini-open Surgical Technique Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 1 Control Group n=16 participants at risk Standard of Care for open or mini-open surgical technique cohort	Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort) Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 2 Control Group n=2 participants at risk Standard of Care for Tubular or Percutaneous Cohort (Minimally Invasive Cohort)	Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) n=13 participants at risk Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 3 Control Group n=30 participants at risk Standard of Care for Limbar decompression without fusion (Outpatient Cohort)
Nervous system disorders Cauda equina syndrome	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	3.3% 1/30 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Musculoskeletal and connective tissue disorders Lumbar Spinal Stenosis	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	3.3% 1/30 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Nervous system disorders Spinal epidural haematoma	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	3.3% 1/30 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

Other adverse events

Other adverse events
Measure	Cohort 1:Open or Mini-open Surgical Technique Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 1 Control Group n=16 participants at risk Standard of Care for open or mini-open surgical technique cohort	Cohort 2: Tubular or Percutaneous (Minimally Invasive Cohort) Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 2 Control Group n=2 participants at risk Standard of Care for Tubular or Percutaneous Cohort (Minimally Invasive Cohort)	Cohort 3: Lumbar Decompression Without Fusion (Outpatient Cohort) n=13 participants at risk Local infiltration Analgesia administered (with EXPAREL and bupivacaine HCl) in EXPAREL arm within cohort. EXPAREL arm to be compared to SOC arm within cohort EXPAREL and Bupivacaine: Drug: EXPAREL and Bupivacaine HCl 0.5% Standard of Care: Standard of Care	Cohort 3 Control Group n=30 participants at risk Standard of Care for Limbar decompression without fusion (Outpatient Cohort)
Nervous system disorders Disturbance in attention	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	16.7% 5/30 • Number of events 5 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Nervous system disorders Dizziness	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	10.0% 3/30 • Number of events 3 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Nervous system disorders Radiculopathy	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	6.7% 2/30 • Number of events 2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Nervous system disorders Somnolence	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	30.0% 9/30 • Number of events 9 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Gastrointestinal disorders Constipation	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	12.5% 2/16 • Number of events 2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	15.4% 2/13 • Number of events 2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	23.3% 7/30 • Number of events 7 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Gastrointestinal disorders Nausea	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	13.3% 4/30 • Number of events 4 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Gastrointestinal disorders Vomiting	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	6.2% 1/16 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	3.3% 1/30 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
General disorders Fatigue	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	16.7% 5/30 • Number of events 5 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
General disorders Peripheral swelling	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Injury, poisoning and procedural complications Extradural Hematoma	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	6.2% 1/16 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Injury, poisoning and procedural complications Foot fracture	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	6.2% 1/16 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Injury, poisoning and procedural complications Postoperative wound complication	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Infections and infestations Cellulitis	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	6.2% 1/16 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Infections and infestations Purulent discharge	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Infections and infestations Stitch abcess	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	15.4% 2/13 • Number of events 2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Infections and infestations Tooth infection	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Musculoskeletal and connective tissue disorders Muscle spasms	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	6.7% 2/30 • Number of events 2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Musculoskeletal and connective tissue disorders Pain in extremity	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Renal and urinary disorders Dysuria	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	10.0% 3/30 • Number of events 3 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Psychiatric disorders Insomnia	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Skin and subcutaneous tissue disorders Pruritus	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/13 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	6.7% 2/30 • Number of events 2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
Investigations Blood pressure decreased	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/16 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	— 0/0 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/2 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	7.7% 1/13 • Number of events 1 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.	0.00% 0/30 • AEs were collected from time of signing informed consent to Day 30 phone call. Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.

Additional Information

Pacira Medical Information

Pacira Pharmaceuticals

Phone: 1-855-793-9727

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Results conducted at Site shall not be published before 1st multicenter publication by Sponsor but can proceed if there is no such publication ≤18 months after study completion/termination at all sites and all data have been received. Before submitting manuscript/materials to an outside person/entity, site shall give Sponsor 60 days to review and comment. Site shall, upon request, further delay publication/presentation for ≤120 days to allow Sponsor to protect its interests in Inventions.
Publication restrictions are in place

Restriction type: OTHER