Evaluation of the Safety and Efficacy of EXPAREL When Administered Into the TAP in Subjects Undergoing Cesarean Section

• Sponsor: Pacira Pharmaceuticals, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02353754
• Collaborator: (none)
• Enrollment: 12
• Locations: 5
• Arms: 2
• Duration (Months): 2
• Patients Per Site: 2.4
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

This is a Phase 4, multicenter, open-label study evaluating EXPAREL infiltration into the transversus abdominis plane (TAP) after bupivacaine hydrochloride (HCl) spinal anesthesia in subjects undergoing elective Cesarean section (C-section).

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Intrathecal morphine injection; Drug: EXPAREL	Phase 4

Detailed Description

There will be two groups of subjects with approximately 40 subjects per group. Prior to the C-section, all subjects will receive single-shot spinal anesthesia (1.5 mL bupivacaine HCl 0.75% with dextrose 8.25%). Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Subjects in Group 2 (EXPAREL/TAP) will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of EXPAREL When Administered Via Infiltration Into the Transversus Abdominis Plane (TAP) After Bupivacaine Spinal Anesthesia in Subjects Undergoing Elective Cesarean Section
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Jun 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.	Drug: Intrathecal morphine injection; 0.2 mg; Other Names: Duramorph
Experimental: EXPAREL/TAP Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).	Drug: EXPAREL; 266 mg; Other Names: Bupivacaine liposome injectable suspension

Outcome Measures

Primary Outcome Measures

1. Total Postsurgical Narcotic Consumption in Morphine Equivalents [Through 72 hours postdose]

   Outcome measure data refer to 7 participants who received rescue medication

Secondary Outcome Measures

1. Total Postsurgical Narcotic Consumption in Morphine Equivalents [Through 24 hours]

   Outcome measure data refer to 6 participants who received rescue medication

2. Total Postsurgical Narcotic Consumption in Morphine Equivalents [Through 48 hours]

   Outcome measure data refer to 7 participants who received rescue medication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Females ≥18 years of age at screening.

2. Scheduled to undergo elective C-section (single or multiple births).

3. American Society of Anesthesiology (ASA) physical status 1, 2, or 3.

4. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

1. History of hypersensitivity or idiosyncratic reaction to amide-type local anesthetics or opioids.

2. Contraindication to bupivacaine, morphine, ketorolac, ibuprofen, or acetaminophen.

3. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.

4. Use of any of the following medications within the times specified before surgery: long-acting opioid medication, non-steroidal anti-inflammatory drugs (NSAIDs), or aspirin (except for low-dose aspirin used for cardioprotection) within 3 days, or any opioid medication or acetaminophen within 24 hours.

5. Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®). If a subject is taking one of these medications for a reason other than pain control, she must be on a stable dose for at least 1 month prior to study drug administration.

6. Clinically significant medical or psychiatric disease that, in the opinion of the Investigator, would constitute a contraindication to participation in the study or cause inability to comply with the study requirements.

7. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medication(s), or alcohol within the past 2 years.

8. Received an investigational drug within 30 days prior to study drug administration, and/or has planned administration of another investigational product or procedure while participating in this study.

9. Previous participating in an EXPAREL study.

The subject will be withdrawn from the study if she meets the following criteria:

1. Any clinically significant event or condition uncovered during the surgery (e.g., excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.

2. Her baby's 5-minute Apgar score is ≤7.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tradition Medical Center	Port Saint Lucie	Florida	United States	34987
2	University Of Minnesota	Minneapolis	Minnesota	United States	55455
3	Saint Peter's University Hospital	New Brunswick	New Jersey	United States	08901
4	Montefiore	Bronx	New York	United States	10467
5	The Ohio State University, Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Pacira Pharmaceuticals, Inc

Investigators

• Study Director: Erol Onel, MD, Pacira Pharmaceuticals, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pacira Pharmaceuticals, Inc
• ClinicalTrials.gov Identifier: NCT02353754
• Other Study ID Numbers: 402-C-402
• First Posted: Feb 3, 2015
• Last Update Posted: Mar 26, 2021
• Last Verified: Mar 1, 2021

• Additional relevant MeSH terms: Morphine; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Standard of Care	EXPAREL/TAP
Arm/Group Description	Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Period Title: Overall Study
STARTED	12	0
COMPLETED	10	0
NOT COMPLETED	2	0

Baseline Characteristics

Arm/Group Title	Standard of Care	EXPAREL/TAP	Total
Arm/Group Description	Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg	Total of all reporting groups
Overall Participants	12	0	12
Age (Count of Participants)
<=18 years	0 0%	0 NaN
Between 18 and 65 years	12 100%	12 Infinity
>=65 years	0 0%	0 NaN
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.2 (4.71)	32.2 (4.71)
Sex/Gender, Customized (participants) [Number]
Female	12 100%	12 Infinity
Male	0 0%	0 NaN
Region of Enrollment (participants) [Number]
United States	12 100%	12 Infinity

Outcome Measures

1. Primary Outcome

Title	Total Postsurgical Narcotic Consumption in Morphine Equivalents
Description	Outcome measure data refer to 7 participants who received rescue medication
Time Frame	Through 72 hours postdose

Outcome Measure Data

Analysis Population Description

The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.

Arm/Group Title	Standard of Care	EXPAREL/TAP
Arm/Group Description	Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Measure Participants	12	0
Mean (Standard Deviation) [MUEs]	6.1 (3.67)

2. Secondary Outcome

Title	Total Postsurgical Narcotic Consumption in Morphine Equivalents
Description	Outcome measure data refer to 6 participants who received rescue medication
Time Frame	Through 24 hours

Outcome Measure Data

Analysis Population Description

The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.

Arm/Group Title	Standard of Care	EXPAREL/TAP
Arm/Group Description	Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Measure Participants	12	0
Mean (Standard Deviation) [MUEs]	4.9 (2.01)

3. Secondary Outcome

Title	Total Postsurgical Narcotic Consumption in Morphine Equivalents
Description	Outcome measure data refer to 7 participants who received rescue medication
Time Frame	Through 48 hours

Outcome Measure Data

Analysis Population Description

The study was terminated due to slow enrollment after 12 subjects were assigned to Group 1 (Standard of Care/Duramorph). As no subjects were enrolled into Group 2 (EXPAREL/TAP), no conclusions can be drawn regarding the study endpoints.

Arm/Group Title	Standard of Care	EXPAREL/TAP
Arm/Group Description	Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg	Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
Measure Participants	12	0
Mean (Standard Deviation) [MUEs]	6.1 (3.67)

Adverse Events

Arm/Group Title	Standard of Care		EXPAREL/TAP
Arm/Group Description	Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered. Intrathecal morphine injection: 0.2 mg		Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen). EXPAREL: 266 mg
All Cause Mortality
	Standard of Care		EXPAREL/TAP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Standard of Care		EXPAREL/TAP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Standard of Care		EXPAREL/TAP
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)		0/0 (NaN)
Infections and infestations
oral herpes	1/12 (8.3%)	1	0/0 (NaN)	0
Injury, poisoning and procedural complications
bladder injury	1/12 (8.3%)	1	0/0 (NaN)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.