A Comparison of the Post-C/S Analgesic Effects of Neuraxial Duramorph vs Bilateral TAP Block With Liposomal Bupivacaine

NCT03638011 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 2018-04-01-MMC
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective is to reduce or eliminate the use of all narcotics/opiates for post Cesarean section pain management. The investigators hypothesize that in comparison with epidural or intrathecal Duramorph, a TAP block with liposomal bupivacaine (Exparel) will provide better, longer-acting pain control and will significantly reduce the use of post-operative IV or p.o. opiates. This is a prospective, randomized clinical trial.

Conditions

Caesarean Section

Keywords

Cesarean Section; Pregnancy

Outcome Measures

Primary Outcomes (2)

• Pain Assessed by Visual Analog Scale (VAS) at 48 Hours

  To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).

  48 hours

• Pain Assessed by Visual Analog Scale (VAS) at 72 Hours

  To evaluate pain, participant will be shown a card that has a visual analogue (Faces) pains scale combined with numerical (0-10) analogue scale (0 is no pain, 10 is the worst pain imaginable).

  72 hours

Secondary Outcomes (2)

• Number of Participants Using Narcotics

  72 hours

• Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale

  72 hours

Study Arms (2)

Standard of Care

NO INTERVENTION

These participant will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They standard neuraxial anesthesia with neuraxial Duramorph for post-operative pain.

Bilateral TAP Block

ACTIVE COMPARATOR

These participants will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control. They will receive standard neuraxial anesthesia without neuraxial Duramorph and a transverse abdominal plane (TAP) blocks immediately after surgery, with a mixture of bupivacaine and Exparel, for post-operative analgesia.

Drug: Exparel

Interventions

Exparel DRUG

Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL

Also known as: TAP Block

Bilateral TAP Block

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: It is a status post C-section study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females, aged 18-45 years inclusive and ASA physical status 1-3.
• Undergoing non-urgent Cesarean section with neuraxial anesthesia/analgesia.
• Subjects must be physically and mentally able to participate in the study and complete all study assessments.
• Subjects must be able to give fully informed consent to participate in this study after demonstrating a good understanding of the risks and benefits of the proposed components of the TAP infiltration.

You may not qualify if:

• History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics
• Any subject whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful performance of a bilateral TAP infiltration.
• Any subject who in the opinion of the Investigator, might be harmed or be a poor candidate for participation in the study.
• Any subject, who in the opinion of the Investigator, is on chronic pain medicine, including large doses of NSAIDs.
• Subjects who have received any investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during their participation in this study.

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (2)

Kalpana Tyagaraj

Brooklyn, New York, 11219, United States

Location

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (7)

• Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017 Nov 1;152(11):1066-1071. doi: 10.1001/jamasurg.2017.0831.

  PMID: 28768328 BACKGROUND

• Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.

  PMID: 24237004 BACKGROUND

• Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.

  PMID: 22632762 BACKGROUND

• Niraj G, Searle A, Mathews M, Misra V, Baban M, Kiani S, Wong M. Analgesic efficacy of ultrasound-guided transversus abdominis plane block in patients undergoing open appendicectomy. Br J Anaesth. 2009 Oct;103(4):601-5. doi: 10.1093/bja/aep175. Epub 2009 Jun 26.

  PMID: 19561014 BACKGROUND

• Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.

  PMID: 25170277 BACKGROUND

• Dennis Feierman, Aden Bronstein, Miriam Flaum, Marc Dany Mohit Garg, Piyush Gupta and Kalpana Tyagaraj; A case series of 12 patient receiving bilateral Transverse Abdominis Plane blocks after cesarean section Open Journal of Anesthesiology December 2017: DOI: 10.4236/ ojanes.2017.712042

  BACKGROUND

• Pack insert for Exparel

  BACKGROUND

Results Point of Contact

• Title: Dr Dennis Feierman
• Organization: Maimonides Medical Center

dfeierman@maimonidesmed.org

718-283-6000

Study Officials

• Kalpana Tyagaraj, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of OB anesthesia

Model Details: This is a prospective, randomized study evaluating the effectiveness of abdominal analgesia when using 266 mg EXPAREL delivered into the bilateral TAP blocks. TAP blocks are an excellent method for providing adequate analgesia following lower abdominal surgery. Those patients who wish to participate will be asked to sign a study consent form. Patients that decide to participate in this study will be randomized to either group 1 or group 2 (like the flip of a coin). Both groups will receive standard neuraxial anesthesia for their Cesarean Section and post-operative standard of care breakthrough medications for post-operative pain control.

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: August 20, 2018
• Study Start: September 25, 2018
• Primary Completion: March 31, 2020
• Study Completion: June 30, 2020
• Last Updated: June 7, 2022
• Results First Posted: March 3, 2021

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)