Trial Outcomes & Findings for Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections (NCT NCT03176459)

Last Updated: 2021-01-06

Results Overview

The primary endpoint is the total postsurgical opioid consumption (mg) in oral morphine equivalent dose (OMED) through 72 hours.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

186 participants

Primary outcome timeframe

0-72 hours

Results posted on

2021-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Overall Study STARTED	96	90
Overall Study COMPLETED	91	83
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Overall Study Lost to Follow-up	5	7

Baseline Characteristics

Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the TAP vs. Bupivacaine Alone in Subjects Undergoing Elective C-Sections

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=97 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=89 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.	Total n=186 Participants Total of all reporting groups
Age, Continuous	33.6 years STANDARD_DEVIATION 5.37 • n=99 Participants	33.1 years STANDARD_DEVIATION 4.43 • n=107 Participants	33.4 years STANDARD_DEVIATION 4.94 • n=206 Participants
Sex: Female, Male Female	97 Participants n=99 Participants	89 Participants n=107 Participants	186 Participants n=206 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=99 Participants	11 Participants n=107 Participants	23 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=99 Participants	78 Participants n=107 Participants	162 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants	0 Participants n=107 Participants	1 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	5 Participants n=99 Participants	5 Participants n=107 Participants	10 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	13 Participants n=99 Participants	15 Participants n=107 Participants	28 Participants n=206 Participants
Race (NIH/OMB) White	67 Participants n=99 Participants	64 Participants n=107 Participants	131 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	3 Participants n=107 Participants	4 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=99 Participants	2 Participants n=107 Participants	13 Participants n=206 Participants
Region of Enrollment United States	97 participants n=99 Participants	89 participants n=107 Participants	186 participants n=206 Participants
American Society of Anesthesiologists classification ASA 1	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
American Society of Anesthesiologists classification ASA 2	90 Participants n=99 Participants	80 Participants n=107 Participants	170 Participants n=206 Participants
American Society of Anesthesiologists classification ASA 3	6 Participants n=99 Participants	8 Participants n=107 Participants	14 Participants n=206 Participants

PRIMARY outcome

Timeframe: 0-72 hours

Population: Efficacy analysis set (also the modified intent-to-treat \[mITT\] analysis set) included all randomized subjects in the safety analysis set who underwent C-section and who also met the study criteria for correct TAP placement, local anesthetic dosing, and a multimodal post-operative analgesic regimen, with analysis based on randomized treatment (regardless of treatment received)

The primary endpoint is the total postsurgical opioid consumption (mg) in oral morphine equivalent dose (OMED) through 72 hours.

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Total Postsurgical Opioid Consumption Through 72 Hours After TAP Infiltration During Elective Cesarean Section	15.5 MED, mg Standard Error 6.67	32.0 MED, mg Standard Error 6.25

SECONDARY outcome

Timeframe: 0-72 hours

AUC for VAS pain scores through 72 hours. Pain intensity scores were measured on a 10-cm VAS (0 cm= "no pain" to 30 cm="pain as bad as it could be"). Subjects were evaluated for pain intensity scores at rest using the 10-cm VAS at rest at 6, 12, 18, 24, 30, 36, 42, 48, and 72 hours after surgery and then once daily (at noon ± 4 hours) through Day 14. To assess pain intensity (VAS) at rest, the subject should rest quietly in a supine or seated position that does not exacerbate her postsurgical pain for 3-5 minutes before entering the pain score. While in the hospital, subjects are to assess, "How much pain are you experiencing right now?" and a vertical mark is placed on a 10-cm straight line to indicate the level of pain experienced at the time of assessment. Note higher AUC means more pain over time.

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=70 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Area Under the Curve (AUC) for Visual Analog Scale (VAS) Pain Scores Through 72 Hours	147.9 cm*hr Standard Error 21.13	178.5 cm*hr Standard Error 19.78

SECONDARY outcome

Timeframe: 0-72 hours

Subjects were considered opioid-spared if: * For 0-72 hours opioid consumption, all doses add up to ≤15mg (oral morphine equivalent dose \[OMED\]) * AND the overall benefit of anesthesia score (OBAS) score was 0 for questions 2, 3, 4, 5, and 6. For the OBAS questionnaire, 0 is considered minimal pain and 4 is considered maximum imaginable pain.

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Opioid Spared Subjects Through 72 Hours	53.5 percent of participants	24.7 percent of participants

SECONDARY outcome

Timeframe: 0-24 hours

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Total Postsurgical Opioid Consumption Through 24 Hours	2.4 MED mg Standard Error 1.82	5.6 MED mg Standard Error 1.70

SECONDARY outcome

Timeframe: 0-48 hours

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Total Postsurgical Opioid Consumption Through 48 Hours	9.1 MED mg Standard Error 4.46	20.5 MED mg Standard Error 4.18

SECONDARY outcome

Timeframe: 0-168 hours

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Total Postsurgical Opioid Consumption Through 168 Hours (Day 7)	23.3 MED mg Standard Error 9.75	45.8 MED mg Standard Error 9.13

SECONDARY outcome

Timeframe: 0-336 hours

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Total Postsurgical Opioid Consumption Through 336 Hours (Day 14)	28.2 MED mg Standard Error 11.20	47.8 MED mg Standard Error 10.49

SECONDARY outcome

Timeframe: From the end of surgery

The time to a subject's first use of an opioid medication for breakthrough pain after the end of surgery

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Time to First Rescue Medication Use	53.2 hours Interval 2.3 to 345.2	41.1 hours Interval 2.5 to 345.7

SECONDARY outcome

Timeframe: 0-72 hours

Percentage of subjects who did not received an opioid rescue medication starting from the end of surgery through 72 hours

Outcome measures

Outcome measures
Measure	EXPAREL 266mg + Immediate Release (IR) Bupivacaine n=71 Participants 60 mL of a study drug mixture containing 20 mL EXPAREL (266 mg) combined with 20 mL bupivacaine HCl 0.25% (50 mg bupivacaine HCl or 44 mg bupivacaine HCl free base equivalents, calculated as 0.886 mg bupivacaine HCl free base = 1.0 mg bupivacaine HCl equivalents) and 20 mL normal saline (total mixture 60 mL) administered into the transversus abdominis plane (TAP), with half of the volume (30 mL) administered to each side of the abdomen.	IR Bupivacaine n=65 Participants 60 mL of a study drug mixture containing 20 mL bupivacaine HCl 0.25% (50 mg) combined with 40 mL normal saline (total mixture 60 mL) administered into the TAP, with half of the volume (30 mL) administered to each side of the abdomen.
Opioid-Free Subjects Through 72 Hours	51.9 percent of opioid-free participants	48.6 percent of opioid-free participants

Adverse Events

EXPAREL+Bupivacaine TAP Infiltration

Serious events: 3 serious events

Other events: 63 other events

Deaths: 0 deaths

Active Bupivacaine TAP Infiltration

Serious events: 3 serious events

Other events: 50 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EXPAREL+Bupivacaine TAP Infiltration n=97 participants at risk Receive a single 20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL. Exparel + Bupivacaine: EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.	Active Bupivacaine TAP Infiltration n=89 participants at risk Receive 20 mL 0.25% bupivacaine expanded in volume with 40 mL normal saline for a total volume of 60 mL Bupivacaine: Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
Cardiac disorders Cardiomyopathy	1.0% 1/97 • Screening through postsurgical Day 14 An 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% 0/89 • Screening through postsurgical Day 14 An 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 Abdominal wall hematoma	1.0% 1/97 • Screening through postsurgical Day 14 An 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% 0/89 • Screening through postsurgical Day 14 An 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 Panic attack	1.0% 1/97 • Screening through postsurgical Day 14 An 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% 0/89 • Screening through postsurgical Day 14 An 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.
Pregnancy, puerperium and perinatal conditions Retained placenta or membranes	0.00% 0/97 • Screening through postsurgical Day 14 An 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.	1.1% 1/89 • Screening through postsurgical Day 14 An 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.
Pregnancy, puerperium and perinatal conditions Gestational hypertension	0.00% 0/97 • Screening through postsurgical Day 14 An 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.	1.1% 1/89 • Screening through postsurgical Day 14 An 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.
Pregnancy, puerperium and perinatal conditions Postpartum hemorrhage	0.00% 0/97 • Screening through postsurgical Day 14 An 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.	1.1% 1/89 • Screening through postsurgical Day 14 An 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 tract infection	0.00% 0/97 • Screening through postsurgical Day 14 An 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.	1.1% 1/89 • Screening through postsurgical Day 14 An 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

Other adverse events
Measure	EXPAREL+Bupivacaine TAP Infiltration n=97 participants at risk Receive a single 20-mL dose of EXPAREL 266 mg expanded in volume with 20 mL normal saline plus 20 mL 0.25% bupivacaine for a total volume of 60 mL. Exparel + Bupivacaine: EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.	Active Bupivacaine TAP Infiltration n=89 participants at risk Receive 20 mL 0.25% bupivacaine expanded in volume with 40 mL normal saline for a total volume of 60 mL Bupivacaine: Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
Gastrointestinal disorders Constipation	6.2% 6/97 • Screening through postsurgical Day 14 An 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.	4.5% 4/89 • Screening through postsurgical Day 14 An 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	24.7% 24/97 • Screening through postsurgical Day 14 An 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.	12.4% 11/89 • Screening through postsurgical Day 14 An 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 Vomiting	12.4% 12/97 • Screening through postsurgical Day 14 An 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.	6.7% 6/89 • Screening through postsurgical Day 14 An 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	3.1% 3/97 • Screening through postsurgical Day 14 An 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.	5.6% 5/89 • Screening through postsurgical Day 14 An 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 Dizziness	6.2% 6/97 • Screening through postsurgical Day 14 An 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.	5.6% 5/89 • Screening through postsurgical Day 14 An 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	6.2% 6/97 • Screening through postsurgical Day 14 An 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.	11.2% 10/89 • Screening through postsurgical Day 14 An 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 pruritis	27.8% 27/97 • Screening through postsurgical Day 14 An 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.	31.5% 28/89 • Screening through postsurgical Day 14 An 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	5.2% 5/97 • Screening through postsurgical Day 14 An 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.	3.4% 3/89 • Screening through postsurgical Day 14 An 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

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