drugset / Trial / NCT04680221
Stopping Opioid Overuse in Obstetrics to Halt Exposure Trial
Phase 4
Active not recruiting
97 enrolled
University of Missouri, Kansas City
Truman Medical Center · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
As the opioid epidemic continues on, more research is needed on multi-modal approaches to decrease opioid exposure after common procedures. The aim of this study is to investigate the role of a transverses abdominis block using liposome bupivacaine suspension in reducing use of opioid medications through post-operative day 7. The study is a proposed double-blind, randomized controlled trial.
Timeline
- Start
- 2021-03-01
- Primary completion
- 2025-06-01
- Completion
- 2025-06-01
Publications
- Background Martin JA, Hamilton BE, Osterman MJK, Driscoll AK. Births: Final Data for 2018. Natl Vital Stat Rep. 2019 Nov;68(13):1-47.
- Background Peahl AF, Dalton VK, Montgomery JR, Lai YL, Hu HM, Waljee JF. Rates of New Persistent Opioid Use After Vaginal or Cesarean Birth Among US Women. JAMA Netw Open. 2019 Jul 3;2(7):e197863. doi: 10.1001/jamanetworkopen.2019.7863.
- Background Badreldin N, Grobman WA, Chang KT, Yee LM. Opioid prescribing patterns among postpartum women. Am J Obstet Gynecol. 2018 Jul;219(1):103.e1-103.e8. doi: 10.1016/j.ajog.2018.04.003. Epub 2018 Apr 7.
- Background 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.
- Background Tuthill EL, McGrath JM, Graber M, Cusson RM, Young SL. Breastfeeding Self-efficacy: A Critical Review of Available Instruments. J Hum Lact. 2016 Feb;32(1):35-45. doi: 10.1177/0890334415599533. Epub 2015 Aug 28.
- Background Dennis CL. The breastfeeding self-efficacy scale: psychometric assessment of the short form. J Obstet Gynecol Neonatal Nurs. 2003 Nov-Dec;32(6):734-44. doi: 10.1177/0884217503258459.
- Background Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.
- Background Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.
- Background Babazade R, Vadhera RB, Krishnamurthy P, Varma A, Doulatram G, Saade GR, Turan A. Acute postcesarean pain is associated with in-hospital exclusive breastfeeding, length of stay and post-partum depression. J Clin Anesth. 2020 Jun;62:109697. doi: 10.1016/j.jclinane.2019.109697. Epub 2019 Dec 31.
- Background Mustafa HJ, Wong HL, Al-Kofahi M, Schaefer M, Karanam A, Todd MM. Bupivacaine Pharmacokinetics and Breast Milk Excretion of Liposomal Bupivacaine Administered After Cesarean Birth. Obstet Gynecol. 2020 Jul;136(1):70-76. doi: 10.1097/AOG.0000000000003886.
- Background Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 266 mg | Other |