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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03638011
Other study ID # 2018-04-01-MMC
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date September 25, 2018
Est. completion date June 30, 2020

Study information

Verified date May 2022
Source Maimonides Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

The investigators will compare the analgesic efficacy and duration of an ultrasound guided bilateral TAP Block (with combined bupivacaine and liposomal bupivacaine) to Duramorph (an opiate). Neuraxial duramorph provides approximately 24 hours of pain relief (analgesia), whereas a bilateral TAP block with liposomal bupivacaine is expected to provide up to 72 hours of analgesia. All participants will have neuraxial anesthesia (either a spinal or epidural) for their non-urgent or elective Cesarean section. The control group (Group 1) will receive either intrathecal or epidural Duramorph (preservative-free morphine sulfate). Post-operatively, participants will have orders to receive, on an as-needed basis, IV/oral acetaminophen and/or IV/oral non-steroidal anti-inflammatory drugs (NSAIDS) for mild-moderate pain, and narcotics for severe pain; specifically- oxycodone or hydromorphone. All patients must receive acetaminophen and NSAIDS (unless contraindicated) before receiving narcotics. This multi-modal pain management regimen is our current standard of care. The experimental group (Group 2) will also receive a spinal or epidural anesthetic. This group will not receive neuraxial Duramorph for post-operative pain. Instead, the patient will receive an ultrasound guided bilateral TAP block with a combination of bupivacaine and liposomal bupivacaine solution immediately after the Cesarean section. Additionally, all participants will receive the same post-operative analgesia orders as group 1.


Recruitment information / eligibility

Status Terminated
Enrollment 71
Est. completion date June 30, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Exparel
Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL

Locations

Country Name City State
United States Kalpana Tyagaraj Brooklyn New York
United States Maimonides Medical Center Brooklyn New York

Sponsors (1)

Lead Sponsor Collaborator
Maimonides Medical Center

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Pack insert for Exparel

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Number of Participants Using Narcotics Total use of narcotics during the post operative period 72 hours
Secondary Patient Satisfaction With Pain Control Assessed by 11 Point Satisfaction Scale Patient satisfaction with postsurgical pain management:
0_____1_____2_____3_____4_____5_____6_____7_____8_____9_____10 0=not at all satisfied 10= extremely satisfied
72 hours
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