Intrathecal Hydromorphone for Cesarean Section

Summary

Introduction: Cesarean section (C/S) is usually performed under spinal with preservative free morphine for pain relief, but the investigators have a severe shortage of this formulation of morphine. Hydromorphone is a narcotic which acts peripherally and centrally to decrease pain. It has been used in spinals for postoperative pain relief and in pain pumps for relief of chronic pain. No randomized controlled studies have evaluated intrathecal (IT) hydromorphone for post C/S pain. Methods: This is a randomized double-blind controlled trial utilizing the up-down sequential allocation method1,2 to find the best dose of IT hydromorphone that provides pain relief following C/S. Patients will be given a morphine PCA pump for additional pain relief. Our first patient will receive 200 mcg of IT hydromorphone. Pain, nausea, and itching will be evaluated at 4, 8, 12 and 24 hours following the C/S via numeric rating scales; vomiting and morphine use per hour will be recorded. Success will be a median morphine usage of less than or equal to 1mg/hour in the following 16 hours. If a success, the next patient will be given 10 mcg less IT hydromorphone; if a failure, she will receive 10 mcg more. The study will end after 5 successes. Objective: The primary objective is to find the optimal dose of IT hydromorphone for pain relief following C/S. The secondary objectives are to define the incidence and severity of hydromorphone's side effects and determine the duration of analgesia.

Timeline

Start

2014-01

Primary completion

2014-12

Completion

2015-06

Publications

• Background 1. Dixon WJ, Massey FJ. Introduction to statistical analysis. 4th ed. New York: McGraw-Hill, 1983; 377-441. 2. Dixon WJ. Staircase bioassay: the up-and-down method. Neurosci Biobehav Rev 1991;15:47-50. 3. AANA J. 2012 Aug;80(4 Suppl):S25-32. 4. AANA J. 2011 Oct;79(5):427-32. 5. Abram SE, Mampilly GA, Milosavljevic D. Anesthesiology 1997;87:127-134. 6. Drakeford MK, Pettine KA, Brookshire L, Ebert F. J Bone Joint Surg Am. 1991;73:424-428. 7. Rathmell JP, Lair TR, Nauman B. Anesth Analg 2005;101(suppl 5):30-43. 8. Sinatra RS, deLeon-Casasola OA, Ginsberg B, Viscusi ER, editors. Acute Pain Management, chapter 16, pp232. 9. Gautier P, Vandepitte C, Ramquet C., et al. Anesth Analg 2011;113:951-55. 10. O'Donnell DB, Iohom G. Anesthesiology 2009;111:25-9. 11. Vandepitte C, Gautier P, Xu D, et al. Anesthesiology 2013;118:863-7

Drugs

Indications

No indication recorded.