Single-dose, sustained-release epidural morphine in the management of postoperative pain after elective cesarean delivery: results of a multicenter randomized controlled study.
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) 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 mug 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.
Carvalho
Brendan
B
*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.
Riley
Edward
E
Cohen
Sheila E
SE
Gambling
David
D
Palmer
Craig
C
Huffnagle
H Jane
HJ
Polley
Linda
L
Muir
Holly
H
Segal
Scott
S
Lihou
Christine
C
Manvelian
Garen
G
D000328:Adult; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002585:Cesarean Section; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010102:Oxygen Inhalation Therapy; D010147:Pain Measurement / Q000187:drug effects; D010149:Postoperative Pain / Q000188:drug therapy*; D011247:Pregnancy
D000701:Analgesics, Opioid; D003692:Delayed-Action Preparations; D009020:Morphine