Ketorolac for Analgesia followiNG Autologous Breast RecOnstructiOn

Summary

Background: Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug that has been shown to reduce breakthrough narcotic consumption following orthopaedic, neurosurgical, and obstetrical procedures. The morphine-sparing effect of ketorolac may reduce respiratory and central nervous system depression post operatively, while still providing adequate pain control for patients. Patients undergoing abdominally based microsurgical breast reconstruction may particularly benefit from ketorolac postoperatively, and ultimately be safely discharged from hospital sooner than their counterparts receiving standard of care. Research Question: In adult women post-mastectomy, undergoing abdominally based microsurgical breast reconstruction, does a postoperative regimen of intravenous ketorolac tromethamine, in addition to standard of care, reduce the length of postoperative hospital stay compared with an intravenous sham saline regimen? Study Design: A single center, explanatory, placebo-controlled, 1:1 allocation, 2-arm, parallel group, superiority, randomized, and double blinded, controlled trial. Population: The study population includes all females \>18 years old post mastectomy consenting to abdominally based microsurgical breast reconstruction. Intervention and Comparator: The intervention will be ketorolac 30 mg IV every 6 hours postoperatively for 72 hours. The comparator will be a sham intravenous administration of normal saline. Outcomes: The primary outcome is hospital length of stay postoperatively. Secondary outcomes include visual analog scale for pain, breakthrough narcotic consumption, surgical drain outputs, hematoma, and other complications. Sample Size: Available data provided estimates for average length of hospital stay and standard deviation. A minimally clinically significant difference of 1 day was decided on due to expert opinion. Based on a power of 80% and alpha of 0.05, and inflated to account for attrition and efficiency losses, a total of 50 patients (25 per group) will be required for this study.

Timeline

Start

2017-11

Primary completion

2019-01

Completion

2019-06

Publications

• Background Bonde C, Khorasani H, Eriksen K, Wolthers M, Kehlet H, Elberg J. Introducing the fast track surgery principles can reduce length of stay after autologous breast reconstruction using free flaps: A case control study. J Plast Surg Hand Surg. 2015;49(6):367-71. doi: 10.3109/2000656X.2015.1062387. Epub 2015 Jul 10.
• Background Zhong T, Ojha M, Bagher S, Butler K, Srinivas C, McCluskey SA, Clarke H, O'Neill AC, Novak CB, Hofer SOP. Transversus abdominis plane block reduces morphine consumption in the early postoperative period following microsurgical abdominal tissue breast reconstruction: a double-blind, placebo-controlled, randomized trial. Plast Reconstr Surg. 2014 Nov;134(5):870-878. doi: 10.1097/PRS.0000000000000613.

Drugs

Indications