Post C-Section Pain Control Using EXPAREL

NCT03377595 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: OBGYN-2017-26339
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  Total opioid medication use by patient after having cesarean section

  72 hours

Secondary Outcomes (7)

• Time to first rescue opioid pain medication

  72 hours

• Percentage of opioid-free subjects

  24,48, and 72 hours

• Patient's satisfaction

  through 72 hours post-op or at discharge

• VAS (visual analogue scale) pain scores

  at 6, 12, 18, 24, 30, 36, 42, 48, and 72 hours after surgery

• Number of participants with EXPAREL related adverse events

  through day 14 post-op

Study Arms (2)

TAP (Transversus Abdominis Plane) block

EXPERIMENTAL

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

Wound infiltration

EXPERIMENTAL

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

Interventions

Exparel DRUG

TAP (Transversus Abdominis Plane) block

Also known as: Saline

TAP (Transversus Abdominis Plane) block

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females 18 years of age and older at screening.
• Term pregnancies of 37 to 42 weeks gestation, scheduled to undergo elective C-section.
• 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

You may not qualify if:

• Age \<18
• BMI \> or equal to 40 or otherwise not anatomically appropriate to undergo a TAP block.
• Planned general anesthetic
• Cesarean delivery via vertical skin incision
• Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications.
• Planned concurrent surgical procedure with the exception of salpingo-oophorectomy or tubal ligation.
• 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.)
• 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).
• 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.
• 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.
• History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• 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
• Previous participation in an EXPAREL study.
• 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.
• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Hiba Mustafa, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2017
• First Posted: December 19, 2017
• Study Start: July 2, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 1, 2019
• Last Updated: May 18, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)