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OBSTETRIC ANESTHESIA

Single-Dose, Sustained-Release Epidural Morphine in the Management of Postoperative Pain After Elective Cesarean Delivery: Results of a Multicenter Randomized Controlled Study

Brendan Carvalho, MBBCh, FRCA^*, Edward Riley, MD^*, Sheila E. Cohen, MBChB, FRCA^*, David Gambling, MB, BS, FRCPC, Craig Palmer, MD, H. Jane Huffnagle, DO, Linda Polley, MD^||, Holly Muir, MD^¶, Scott Segal, MD^#, Christine Lihou, CCRA^**, Garen Manvelian, MD^** for the DepoDur Study Group

*Department of Anesthesia, Stanford University School of Medicine, Stanford, California; Sharp Mary Birch Hospital for Women, San Diego, California; Department of Anesthesiology, University of Arizona Health Sciences Center, Tucson, Arizona; Department of Anesthesiology, Thomas Jefferson University, Philadelphia, Pennsylvania; ||Department of Anesthesiology, University of Michigan Medical School, Ann Arbor, Michigan; ¶Department of Anesthesiology, Duke University, Durham, North Carolina; #Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women’s Hospital, Boston, Massachusetts; and **SkyePharma, Inc., San Diego, California

Address correspondence and reprint requests to Brendan Carvalho, MBBCh, FRCA, Department of Anesthesia, Stanford University School of Medicine, 300 Pasteur Dr., Stanford, CA 94305. Address e-mail to bcarvalho{at}stanford.edu.

In this multicenter, randomized, controlled study, we compared the analgesic efficacy and safety profile of a new single-dose extended-release epidural morphine (EREM) formulation (DepoDur^TM) with that of epidural morphine sulfate for the management of postoperative pain for up to 48 h after elective cesarean delivery. ASA physical status I or II parturients (n = 75) were anesthetized with a combined spinal/epidural technique. Parturients received intrathecal bupivacaine 12–15 mg and fentanyl 10 µg for spinal anesthesia and a single epidural injection of either 5 mg of standard (conventional preservative-free) morphine or 5, 10, or 15 mg of extended-release morphine after cord clamping for postoperative pain control. Single-dose EREM 10 and 15 mg groups significantly decreased total supplemental opioid medication use and improved functional ability scores for 48 h after surgery compared with those receiving 5 mg of standard morphine. Visual analog scale pain scores at rest and with activity at 24 to 48 h after dosing were significantly better in the 10- and 15-mg single-dose EREM groups versus the standard morphine group. There were no significant differences between the two 5 mg (single-dose EREM and standard morphine) groups. Single-dose EREM was well tolerated, and most adverse events were mild to moderate in severity. Single-dose EREM is a potentially beneficial epidural analgesic for the management of post-cesarean delivery pain and has particular advantages over standard morphine for the period from 24 to 48 h after surgery.

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