Caesarean Section Clinical Trial
Official title:
A Comparison of the Post-cesarean Section Analgesic Effects of Neuraxial Duramorph vs. Bilateral Transverse Abdominal Plane Block With Combined Bupivacaine/Liposomal Bupivacaine (Exparel)
Verified date | May 2022 |
Source | Maimonides Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Kalpana Tyagaraj | Brooklyn | New York |
United States | Maimonides Medical Center | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Maimonides Medical Center |
United States,
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
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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