Post C-Section Pain Control Using EXPAREL

Post-cesarean Section Analgesic Safety and Efficacy of EXPAREL (Liposomal Bupivacaine) Infiltration Locally Versus Transversus Abdominis Plane Infiltration

Evaluating the safety and efficacy of EXPAREL (Liposomal Bupivacaine ) for pain control in patients undergoing scheduled cesarean section by giving it either as infiltration in Transversus Abdominis Plane after finishing the procedure or through wound infiltration into the fascia prior to closure of skin

Study Overview

• Status: Withdrawn
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Exparel; Drug: Exparel

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Females 18 years of age and older at screening.
2. Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
3. ASA (American Society of Anesthesiologists) physical status 1, 2, or 3 are able to provide informed consent, adhere to the study visit schedule, and complete all study assessments

Exclusion Criteria:

1. Age <18
2. BMI > or equal to 40 or otherwise not anatomically appropriate to undergo a TAP block.
3. Planned general anesthetic
4. Cesarean delivery via vertical skin incision
5. Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
6. Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
7. Severely impaired renal or hepatic function (eg, serum creatinine level >2 mg/dL [176.8 µmol/L], blood urea nitrogen level >50 mg/dL [17.9 mmol/L], serum aspartate aminotransferase [AST] level >3 times the upper limit of normal , or serum alanine aminotransferase [ALT] level >3 times the upper limit of normal.)
8. Subjects at an increased risk for bleeding or a coagulation disorder (defined as platelet count less than 80, 000 × 103/mm3 or international normalized ratio greater than 1.5).
9. Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the postsurgical period for pain that is not strictly related to the surgery and which may confound the postsurgical assessments.
10. Clinically significant medical disease in either the mother or baby that, in the opinion of the investigator, would make participation in a clinical study inappropriate. This includes any psychiatric or other disease in the mother that would constitute a contraindication to participation in the study or cause the mother to be unable to comply with the study requirements.
11. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
12. Administration of an investigational drug within 30 days or 5 elimination half-lives of such investigational drug, whichever is longer, prior to study drug administration, or planned administration of another investigational product or procedure during the subject's participation in this study
13. Previous participation in an EXPAREL study.
14. Any clinically significant event or condition uncovered during the surgery (eg, excessive bleeding, acute sepsis) that might render the subject medically unstable or complicate the subject's postsurgical course.
15. 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.
16. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP (Transversus Abdominis Plane) block; 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 m.A 2-point classic TAP block will be performed under ultrasound guidance within 1 hour (± 30 minutes) following skin incision closure of the C-section.	Drug: Exparel; TAP (Transversus Abdominis Plane) block; Other Names: Saline; Drug: Exparel; Wound infiltration; Other Names: Saline
Experimental: Wound infiltration; 20 mL of EXPAREL 266 mg expanded in volume with 40 mL normal saline for a total volume of 60 mL, infiltrated in the fascia prior to skin closure with attention to infiltrate the angles of the incision.	Drug: Exparel; TAP (Transversus Abdominis Plane) block; Other Names: Saline; Drug: Exparel; Wound infiltration; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	Total opioid medication use by patient after having cesarean section	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue opioid pain medication	Time till the patient asks for opioid medication for breakthrough pain	72 hours
Percentage of opioid-free subjects	Percentage of patients didn't require any opioid medications after the cesarean section	24,48, and 72 hours
Patient's satisfaction	Patient's satisfaction questionnaire with pain control	through 72 hours post-op or at discharge
VAS (visual analogue scale) pain scores	pain level assessment using visual assessment pain score which ranges from zero for no pain to 10 intolerable pain	at 6, 12, 18, 24, 30, 36, 42, 48, and 72 hours after surgery
Number of participants with EXPAREL related adverse events	side effects of EXPAREL	through day 14 post-op
Allergic reactions attributable to local anesthetic use	Such as allergies, rash etc...	through day14 post-op
Wound complications	cesarean section wound complications like infection, hematoma, and dehiscence	through day 14 post-op

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Hiba Mustafa, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2019
• Primary Completion (Actual): August 30, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: OBGYN-2017-26339

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes