drugset / Trial / NCT06925152
COMFORT Trial: Complex Obstetric Management With Focused Regional Transversus Abdominis Plane Block
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To assess the effect of intraoperative transversus abdominis plane (TAP) blocks on the amount of opioid pain medications expressed as morphine milliequivalents (MME) used postoperatively in patients who have undergone cesarean delivery (CD) in the setting of complex obstetric surgery (COS).
Timeline
- Start
- 2025-07-15
- Primary completion
- 2028-05
- Completion
- 2028-05
Publications
- Background McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
- 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.
- Background Zhang, X., et al. (2017).
- Background Kehlet, H., et al. (2014).
- Background Garmi G, Parasol M, Zafran N, Rudin M, Romano S, Salim R. Efficacy of Single Wound Infiltration With Bupivacaine and Adrenaline During Cesarean Delivery for Reduction of Postoperative Pain: A Randomized Clinical Trial. JAMA Netw Open. 2022 Nov 1;5(11):e2242203. doi: 10.1001/jamanetworkopen.2022.42203.
- Background Abdallah FW, Halpern SH, Margarido CB. Transversus abdominis plane block for postoperative analgesia after Caesarean delivery performed under spinal anaesthesia? A systematic review and meta-analysis. Br J Anaesth. 2012 Nov;109(5):679-87. doi: 10.1093/bja/aes279. Epub 2012 Aug 19.
- Background Ueshima, H., Higashijima, U., Matsumoto, M., & Imai, S. (2013). The effect of the volume of local anesthetic on the analgesic effect of transversus abdominis plane block in abdominal surgery. Journal of Anesthesia, 27(6), 650-655.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Bupivacaine | Other / unclassified | 0.5 % | Other |
| Comparator | Bupivacaine | Other / unclassified | 15 ml | Other |