Post C-Section Pain Control Using EXPAREL

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03377595
• Other study ID #: OBGYN-2017-26339
• Status: Withdrawn
• Phase: Phase 4
• Start date: July 2, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: May 2021
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Exparel
TAP (Transversus Abdominis Plane) block
• Exparel
Wound infiltration

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total opioid consumption	Total opioid medication use by patient after having cesarean section	72 hours
Secondary	Time to first rescue opioid pain medication	Time till the patient asks for opioid medication for breakthrough pain	72 hours
Secondary	Percentage of opioid-free subjects	Percentage of patients didn't require any opioid medications after the cesarean section	24,48, and 72 hours
Secondary	Patient's satisfaction	Patient's satisfaction questionnaire with pain control	through 72 hours post-op or at discharge
Secondary	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
Secondary	Number of participants with EXPAREL related adverse events	side effects of EXPAREL	through day 14 post-op
Secondary	Allergic reactions attributable to local anesthetic use	Such as allergies, rash etc...	through day14 post-op
Secondary	Wound complications	cesarean section wound complications like infection, hematoma, and dehiscence	through day 14 post-op