Trial Outcomes & Findings for Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery (NCT NCT03015961)

NCT ID: NCT03015961

Last Updated: 2021-10-13

Results Overview

AUC of VAS pain intensity scores from 0 to 72 hours postsurgery. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now." AUC curve is derived using the trapezoidal rule (see formula below) on the pain scores. AUC start with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 72 hours post-surgery. (Where pi is the VAS pain score at time i and ti is the time, in hours, from end of surgery. Note t1 is pain score collected after surgery.)

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 38 participants
• Primary outcome timeframe: 0-72 hours
• Results posted on: 2021-10-13

Participant Flow

Participants were recruited between February 21, 2017 and October 30, 2017 at 15 sites in the United States. The study was terminated due to low enrollment.

Participant milestones

Measure	EXPAREL Admixed With Bupivacaine HCl Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl Local infiltration analgesia with bupivacaine hydrochloride (HCl) 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
Overall Study STARTED	18	20
Overall Study COMPLETED	18	18
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery

Baseline characteristics by cohort

Measure	EXPAREL Admixed With Bupivacaine HCl n=18 Participants Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl n=20 Participants Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline	Total n=38 Participants Total of all reporting groups
Age, Continuous	57.3 year STANDARD_DEVIATION 12.13 • n=5 Participants	61.6 year STANDARD_DEVIATION 9.33 • n=7 Participants	59.5 year STANDARD_DEVIATION 10.81 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	9 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	19 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-72 hours

AUC of VAS pain intensity scores from 0 to 72 hours postsurgery. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now." AUC curve is derived using the trapezoidal rule (see formula below) on the pain scores. AUC start with the first pain assessment obtained after surgery and use all subsequent pain assessments up to 72 hours post-surgery. (Where pi is the VAS pain score at time i and ti is the time, in hours, from end of surgery. Note t1 is pain score collected after surgery.)

Outcome measures

Measure	EXPAREL Admixed With Bupivacaine HCl n=18 Participants Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl n=20 Participants Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
Area Under the Curve (AUC) of Visual Analog Scale (VAS) Pain Intensity Scores From 0 to 72 Hours	342.8 score on a scale*hours Interval 1.0 to 624.0	369.0 score on a scale*hours Interval 96.0 to 718.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-24, 0-48, 0-72 hours

Percentage of opioid-free patients through 24, 48 and 72 hours post-surgery

Outcome measures

Measure	EXPAREL Admixed With Bupivacaine HCl n=18 Participants Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl n=20 Participants Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
Percentage of Opioid-Free Patients 0-24 hours	11.11 percentage of opioid-free patients	11.11 percentage of opioid-free patients
Percentage of Opioid-Free Patients 0-48 hours	11.11 percentage of opioid-free patients	5.56 percentage of opioid-free patients
Percentage of Opioid-Free Patients 0-72 hours	11.11 percentage of opioid-free patients	5.56 percentage of opioid-free patients

OTHER_PRE_SPECIFIED outcome

Timeframe: 24-48 hours, 48-72 hours

AUC of the VAS pain intensity scores from 24-48 and 48-72 hours postsurgery. Visual Analog Scale (VAS) is a pain scale. The VAS was presented as a straight 10 cm line, where 0 cm is no pain and 10 cm is the worst pain possible. Patients were asked, "How much pain are you experiencing right now? Please place a vertical mark on the line below to indicate the level of pain you are experiencing right now." AUC from 24-48 hours start with the pain assessment obtained at 24 hours post-surgery and use all subsequent pain assessments up to 48 hours post-surgery. AUC from 48-72 hours start with the pain assessment obtained at 48 hours post-surgery and use all subsequent pain assessments up to 72 hours post-surgery. (Where pi is the VAS pain score at time i and ti is the time, in hours, from end of surgery.)

Outcome measures

Measure	EXPAREL Admixed With Bupivacaine HCl n=18 Participants Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl n=20 Participants Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
Area Under the Curve (AUC) of the Visual Analog Scale (VAS) Pain Intensity Scores From 24-48 and 48-72 Hours Postsurgery 24-48 hours	97.3 score on a scale*hours Interval 0.0 to 185.0	98.1 score on a scale*hours Interval 14.0 to 225.0
Area Under the Curve (AUC) of the Visual Analog Scale (VAS) Pain Intensity Scores From 24-48 and 48-72 Hours Postsurgery 48-72 hours	86.8 score on a scale*hours Interval 0.0 to 187.0	90.6 score on a scale*hours Interval 8.0 to 162.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 0-48 hours

Total Opioid Consumption Through 48 Hours Postsurgery

Outcome measures

Measure	EXPAREL Admixed With Bupivacaine HCl n=18 Participants Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl n=20 Participants Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
Total Opioid Consumption Through 48 Hours Postsurgery	103.6 MED, mg Standard Deviation 101.55	90.8 MED, mg Standard Deviation 100.58

Adverse Events

EXPAREL Admixed With Bupivacaine HCl

Serious events: 1 serious events

Other events: 11 other events

Deaths: 0 deaths

Bupivacaine HCl

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	EXPAREL Admixed With Bupivacaine HCl n=18 participants at risk Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl n=20 participants at risk Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.

Other adverse events

Measure	EXPAREL Admixed With Bupivacaine HCl n=18 participants at risk Local infiltration analgesia with EXPAREL (bupivacaine liposome injectable suspension) 266 mg/20 mL admixed with bupivacaine HCl 0.5% 20 mL and expanded with 20 mL (1-level procedures) or 50 mL (2-level procedures) normal saline	Bupivacaine HCl n=20 participants at risk Local infiltration analgesia with bupivacaine HCl 0.5% 20 mL expanded with 40 mL (1-level procedures) or 70 mL (2-level procedures) normal saline
Nervous system disorders Dizziness	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	20.0% 4/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Nervous system disorders Radiculopathy	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	10.0% 2/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Nervous system disorders Hypoaesthesia	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	10.0% 2/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Gastrointestinal disorders Nausea	16.7% 3/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Gastrointestinal disorders Constipation	16.7% 3/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	10.0% 2/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Injury, poisoning and procedural complications Incision site pain	11.1% 2/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	10.0% 2/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Skin and subcutaneous tissue disorders Pruritus	16.7% 3/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Vascular disorders Hypotension	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	15.0% 3/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Infections and infestations Urinary tract infection	16.7% 3/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Psychiatric disorders Anxiety	11.1% 2/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Renal and urinary disorders Urinary retention	11.1% 2/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Cardiac disorders Tachycardia	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Eye disorders Diplopia	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Gastrointestinal disorders Flatulence	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
General disorders Gait disturbance	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
General disorders Pyrexia	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
General disorders Vessel puncture site bruise	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Injury, poisoning and procedural complications Agitation postoperative	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Injury, poisoning and procedural complications Anaemia postoperative	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Injury, poisoning and procedural complications Contusion	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Injury, poisoning and procedural complications Postoperative fever	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Injury, poisoning and procedural complications Procedural pain	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Investigations Blood creatinine increased	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Investigations Blood glucose increased	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Investigations Blood magnesium decreased	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Investigations Blood pressure increased	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Investigations Electrocardiogram T wave abnormal	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Investigations Pedal pulse decreased	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Back pain	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Muscle tightness	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Nervous system disorders Facial spasm	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Nervous system disorders Headache	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Nervous system disorders Paraesthesia	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Nervous system disorders Tremor	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Psychiatric disorders Mental status changes	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Apnoea	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Skin and subcutaneous tissue disorders Hyperhidrosis	5.6% 1/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	0.00% 0/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Skin and subcutaneous tissue disorders Rash	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.
Vascular disorders Hypertension	0.00% 0/18 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.	5.0% 1/20 • From the time informed consent form is signed to Day 30 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (eg, abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug without any judgment about causality. Serious AEs were defined as per clinicaltrials.gov.

Additional Information

Pacira Medical Information

Pacira Pharmaceuticals, Inc.

Phone: 1-855-793-9727

Email: MedInfo@pacira.com

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