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ASA: Epidural Analgesic Manages Pain After Cesarean Section By Jill Stein SAN FRANCISCO, CA -- November 18, 2003 -- A single epidural dose of sustained-release morphine (DepoMorphine) is showing strong potential for the management of pain after a cesarean section, according to the results of a phase III trial reported here October 19th at the 2003 Annual Meeting of the American Society of Anesthesiologists. Brendan Carvalho, MBBCh, FRCA, and colleagues at Stanford University, California, United States, presented results in 75 parturients undergoing elective cesarean section. The participants all received spinal anesthesia (bupivacaine 12-15 mg IT and fentanyl 10 mcg) and were then randomised to a single epidural dose of 5 mg conventional morphine sulfate or 5, 10, or 15 mg of DepoMorphine. Postoperatively, patients received either oral opioid or intravenous morphine sulfate for breakthrough pain as needed. Oral opioids were converted to intravenous morphine-sulfate milligram equivalents for analysis. "Pain in patients on the first day after a cesarean section usually responds to opioid- containing medications, Tylenol medications, and non-steroidal anti-inflammatory agents," said Mr. Carvalho, clinical instructor in anesthesiology. "However, the pain from cesarean delivery typically becomes problematic on the second day, when the patient starts breastfeeding and generally moving around." DepoMorphine uses a novel sustained-release formulation to provide extended pain relief (up to 48 hours) with a single administration. DepoFoam technology consists of lipid vesicles that release morphine over an extended period. After injection into a patient, the drug is released over time. Overall, single-dose DepoMorphine morphine significantly decreased total supplemental opioid medication use through 48 hours compared with morphine sulfate as well as over intermediate time points compared to the morphine sulfate group. Results also showed a significant improvement in functional ability scores at 24 and 48 hours in the 10- and 15-mg DepoMorphine groups. Pain-intensity ratings were significantly improved with the 10-mg and 15-mg dosages at all time points during the study, especially on day 2, and sustained pain relief was provided with a single epidural dose. The need for supplemental oxygen did not differ in DepoMorphine-treated patients compared with morphine sulfate-treated patients. DepoMorphine was well tolerated, with a safety profile consistent with that of opioid therapy. There were no differences among the treatment groups in the type, frequency, or severity of side effects. Mr. Carvalho said that he is encouraged by the favourable results seen in his study, but emphasised that definitive conclusions cannot be made about the product's side effect profile given the small sample size. This study was sponsored by Skye Pharma, Inc. San Diego, California. [Study Title: Management of Post-Operative Pain Following Cesarean Section with Epidural Sustained-Release Morphine (SKY0401). Abstract A-1165] E-mail this page to a friend or colleague! To print, use this version