Clinical trial NCT03377595: Post C-Section Pain Control Using EXPAREL
Official title: Post-cesarean Section Analgesic Safety and Efficacy of EXPAREL (Liposomal Bupivacaine) Infiltration Locally Versus Transversus Abdominis Plane Infiltration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Total opioid consumption
timeFrame: 72 hours
Secondary outcomes:
measure: Time to first rescue opioid pain medication
timeFrame: 72 hours
measure: Percentage of opioid-free subjects
timeFrame: 24,48, and 72 hours
measure: Patient's satisfaction
timeFrame: through 72 hours post-op or at discharge
measure: VAS (visual analogue scale) pain scores
timeFrame: at 6, 12, 18, 24, 30, 36, 42, 48, and 72 hours after surgery
measure: Number of participants with EXPAREL related adverse events
timeFrame: through day 14 post-op
measure: Allergic reactions attributable to local anesthetic use
timeFrame: through day14 post-op
measure: Wound complications
timeFrame: through day 14 post-op
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Hiba Mustafa, MD
role: PRINCIPAL_INVESTIGATOR
References: