Study Summary
This trial is testing whether a lower dose of morphine given through an epidural decreases side effects, compared to a higher dose.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 2 Secondary · Reporting Duration: One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
Day 2
Outcome of side effects of intervention: nausea
Day 2
Outcome of side effects of intervention: pruritus
Outcome of side effects of intervention: urinary retention
One measurement during entire hospital stay
Maternal from intervention
Within first hour of birth
Neonatal from intervention
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Group A: 150 mcg morphine
1 of 2
Group B: 50 mcg morphine
1 of 2
Active Control
Experimental Treatment
96 Total Participants · 2 Treatment Groups
Primary Treatment: Morphine Sulfate 50mcg · No Placebo Group · Phase < 1
Group B: 50 mcg morphine
Drug
Experimental Group · 1 Intervention: Morphine Sulfate 50mcg · Intervention Types: DrugGroup A: 150 mcg morphine
Drug
ActiveComparator Group · 1 Intervention: Morphine Sulfate 150 mcg · Intervention Types: DrugTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: one assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,432 Previous Clinical Trials
2,218,974 Total Patients Enrolled
Brian Casey, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
1,203 Total Patients Enrolled
Eligibility Criteria
Age Any Age · Female Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
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- McDonnell, John G., Gerard Curley, John Carney, Aoife Benton, Joseph Costello, Chrisen H. Maharaj, and John G. Laffey. 2008. “The Analgesic Efficacy of Transversus Abdominis Plane Block After Cesarean Delivery: A Randomized Controlled Trial”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/01.ane.0000290294.64090.f3.
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- Champaneria, R., L. Shah, M.J. Wilson, and J.P. Daniels. 2016. “Clinical Effectiveness of Transversus Abdominis Plane (TAP) Blocks for Pain Relief After Caesarean Section: A Meta-analysis”. International Journal of Obstetric Anesthesia. Elsevier BV. doi:10.1016/j.ijoa.2016.07.009.
- Blanco, Rafael, Tarek Ansari, and Emad Girgis. 2015. “Quadratus Lumborum Block for Postoperative Pain After Caesarean Section”. European Journal of Anaesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/eja.0000000000000299.
- Hirabayashi, Masato, Katsushi Doi, Noritaka Imamachi, Tomomune Kishimoto, and Yoji Saito. 2017. “Prophylactic Pentazocine Reduces the Incidence of Pruritus After Cesarean Delivery Under Spinal Anesthesia with Opioids”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0000000000002060.
- Bateman, Brian T., Jessica M. Franklin, Katsiaryna Bykov, Jerry Avorn, William H. Shrank, Troyen A. Brennan, Joan E. Landon, et al.. 2016. “Persistent Opioid Use Following Cesarean Delivery: Patterns and Predictors Among Opioid-naïve Women”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2016.03.016.
- TELNES, A., E. SKOGVOLL, and H. LONNÉE. 2015. “Transversus Abdominis Plane Block Vs. Wound Infiltration in Caesarean Section: A Randomised Controlled Trial”. Acta Anaesthesiologica Scandinavica. Wiley. doi:10.1111/aas.12498.
- Sentilhes, Loïc, Christophe Vayssière, Gael Beucher, Catherine Deneux-Tharaux, Philippe Deruelle, Pierre Diemunsch, Denis Gallot, et al.. 2013. “Delivery for Women with a Previous Cesarean: Guidelines for Clinical Practice from the French College of Gynecologists and Obstetricians (CNGOF)”. European Journal of Obstetrics & Gynecology and Reproductive Biology. Elsevier BV. doi:10.1016/j.ejogrb.2013.05.015.
- Lavand’homme, Patricia. 2006. “Postcesarean Analgesia: Effective Strategies and Association with Chronic Pain”. Current Opinion in Anaesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.aco.0000192815.22989.61.
- “Committee Opinion No. 666”. 2016. “Committee Opinion No. 666”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000001487.
- Faiz, Seyed Hamid Reza, Mahmoud Reza Alebouyeh, Pooya Derakhshan, Farnad Imani, Poupak Rahimzadeh, and Maryam Ghaderi Ashtiani. 2017. “Comparison of Ultrasound-guided Posterior Transversus Abdominis Plane Block and Lateral Transversus Abdominis Plane Block for Postoperative Pain Management in Patients Undergoing Cesarean Section: A Randomized Double-blind Clinical Trial Study”. Journal of Pain Research. Informa UK Limited. doi:10.2147/jpr.s146970.
- Ng, S.C., A.S. Habib, S. Sodha, B. Carvalho, and P. Sultan. 2018. “High-dose Versus Low-dose Local Anaesthetic for Transversus Abdominis Plane Block Post-caesarean Delivery Analgesia: A Meta-analysis”. British Journal of Anaesthesia. Elsevier BV. doi:10.1016/j.bja.2017.11.084.
- Abdallah, F.W., J.G. Laffey, S.H. Halpern, and R. Brull. 2013. “Duration of Analgesic Effectiveness After the Posterior and Lateral Transversus Abdominis Plane Block Techniques for Transverse Lower Abdominal Incisions: A Meta-analysis”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aet214.
- Aly, M., A. Ibrahim, W. Farrag, K. Abdelsalam, H. Mohamed, and A. Tawfik. 2018. “Pruritus After Intrathecal Morphine for Cesarean Delivery: Incidence, Severity and Its Relation to Serum Serotonin Level”. International Journal of Obstetric Anesthesia. Elsevier BV. doi:10.1016/j.ijoa.2018.02.004.
- Donauer, Katharina, Hagen Bomberg, Stefan Wagenpfeil, Thomas Volk, Winfried Meissner, and Alexander Wolf. 2018. “Regional Vs. General Anesthesia for Total Knee and Hip Replacement: An Analysis of Postoperative Pain Perception from the International PAIN OUT Registry”. Pain Practice. Wiley. doi:10.1111/papr.12708.
- Blanco, Rafael, Tarek Ansari, Waleed Riad, and Nanda Shetty. 2016. “Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery”. Regional Anesthesia and Pain Medicine. BMJ. doi:10.1097/aap.0000000000000495.
- McDonnell, John G., Gerard Curley, John Carney, Aoife Benton, Joseph Costello, Chrisen H. Maharaj, and John G. Laffey. 2008. “The Analgesic Efficacy of Transversus Abdominis Plane Block After Cesarean Delivery: A Randomized Controlled Trial”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/01.ane.0000290294.64090.f3.
- Abdallah, F.W., J.G. Laffey, S.H. Halpern, and R. Brull. 2013. “Duration of Analgesic Effectiveness After the Posterior and Lateral Transversus Abdominis Plane Block Techniques for Transverse Lower Abdominal Incisions: A Meta-analysis”. British Journal of Anaesthesia. Elsevier BV. doi:10.1093/bja/aet214.
- TELNES, A., E. SKOGVOLL, and H. LONNÉE. 2015. “Transversus Abdominis Plane Block Vs. Wound Infiltration in Caesarean Section: A Randomised Controlled Trial”. Acta Anaesthesiologica Scandinavica. Wiley. doi:10.1111/aas.12498.
- Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
- Lavand'homme P. Postcesarean analgesia: effective strategies and association with chronic pain. Curr Opin Anaesthesiol. 2006 Jun;19(3):244-8. doi: 10.1097/01.aco.0000192815.22989.61.
- Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
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- Telnes A, Skogvoll E, Lonnee H. Transversus abdominis plane block vs. wound infiltration in Caesarean section: a randomised controlled trial. Acta Anaesthesiol Scand. 2015 Apr;59(4):496-504. doi: 10.1111/aas.12498.
- Brian Casey 2020. "Decreased Neuraxial Morphine After Cesarean Delivery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04279054.
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