JOURNAL HOME CME HOME THIS MONTH PAST ISSUES ETOC COLLECTIONS AUTHORS REVIEWERS EDITORIAL BOARD FEEDBACK RSS HELP
		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in ISI Web of Science Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via ISI Web of Science (17) Citing Articles via Google Scholar Google Scholar Articles by Gambling, D. Search for Related Content PubMed PubMed Citation Articles by Gambling, D. Related Collections Postanesthetic Care Unit Regional Anesthesia Pain Pharmacology

---

PAIN MEDICINE

A Comparison of Depodur^TM, a Novel, Single-Dose Extended-Release Epidural Morphine, with Standard Epidural Morphine for Pain Relief After Lower Abdominal Surgery

David Gambling, MB, BS, FRCPC^*, Thomas Hughes, MD, Gavin Martin, MD, William Horton, MD, Garen Manvelian, MD^|| for the Single-Dose EREM Study Group

*Sharp Mary Birch Hospital for Women, San Diego, California; Woodland Memorial Hospital, Woodland, California; Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina; Progressive Research, LLC, Greenville, South Carolina; and ||SkyePharma, Inc., San Diego, California

Address correspondence and reprint requests to David Gambling, MB, BS, FRCPC, Sharp Mary Birch Hospital for Women, Department of Anesthesiology (Second Floor), 3003 Health Center Dr., San Diego, CA 92123. Address e-mail to dgamb{at}san.rr.com.

In this randomized, controlled, dose-ranging study, we evaluated the analgesic efficacy of a novel single-dose extended-release epidural morphine (Depodur^TM) in patients undergoing lower abdominal surgery. Five-hundred-forty-one patients were randomly assigned to one of six epidural treatments administered approximately 30 min before surgery. The 6 treatments were 5 mg of standard epidural morphine sulfate (MS) (active comparator); 5 mg of single-dose extended-release epidural morphine (EREM) (dose control); and 10, 15, 20, and 25 mg of single-dose EREM. The main study objective was to assess the efficacy of single-dose EREM 10, 15, 20, or 25 mg versus single-dose EREM 5 mg for the management of postoperative pain. This was done by plotting a linear dose-response relationship to assess postoperative IV patient-controlled analgesia (PCA) fentanyl consumption for breakthrough pain for 48 h after surgery. Secondary safety and efficacy analyses compared the 10-, 15-, 20-, and 25-mg single-dose EREM groups with the 5-mg single-dose EREM group and compared each single-dose EREM group with 5 mg of MS. As shown by the dose-response relationship, there was a dose-related reduction in the use of postoperative IV fentanyl through 48 h (estimated slope, –22.2; P = 0.0002). Patients treated with 10, 20, and 25 mg of single-dose EREM used significantly less IV fentanyl (mean ± sd: 995 ± 987 µg, P = 0.0446; 972 ± 982 µg, P = 0.0221; and 683 ± 620 µg, P < 0.0001, respectively) through 48 h after surgery compared with the 5-mg single-dose EREM group (1218 ± 894 µg). At 48 h postdose, significantly more single-dose EREM patients (13%) than MS patients (2%) had required no IV fentanyl (P < 0.01). Although all treatment groups had access to PCA fentanyl and there was more frequent PCA fentanyl use in the MS group, patients in the single-dose EREM 15, 20, and 25 mg groups reported significantly lower pain-intensity scores and greater satisfaction with their pain relief. Overall, single-dose EREM was well tolerated, with 97% of adverse events rated as mild to moderate. As expected, the adverse events reported were consistent with those of other epidural opioids (i.e., nausea, vomiting, pruritus, and hypotension). In conclusion, this controlled study demonstrated that single-dose EREM can provide up to 48 h of postoperative analgesia, but supplementation for breakthrough pain is still required in most patients. Within the context of this study, the side effect profile of single-dose EREM was acceptable and predictable.

This article has been cited by other articles:

				B. Carvalho Respiratory Depression After Neuraxial Opioids in the Obstetric Setting Anesth. Analg., September 1, 2008; 107(3): 956 - 961. [Abstract] [Full Text] [PDF]

				C. Vaughan Development and implementation of a process to ensure safe use of morphine sulfate extended-release liposome injection Am. J. Health Syst. Pharm., March 1, 2008; 65(5): 458 - 461. [Full Text] [PDF]

				M. N. Macias, T. G. Hall, and J. Ostlund Extended-release epidural morphine and postoperative nausea or vomiting Am. J. Health Syst. Pharm., February 1, 2008; 65(3): 200 - 200. [Full Text] [PDF]

				C. Sinclair and N. Eipe Recurrent postoperative deep vein thrombosis in a patient with obstructive sleep apnea and malignant hyperthermia susceptibility Can J Anesth, December 1, 2007; 54(12): 1032 - 1033. [Full Text] [PDF]

				B. Carvalho, L. M. Roland, L. F. Chu, V. A. Campitelli III, and E. T. Riley Single-Dose, Extended-Release Epidural Morphine (DepoDurTM) Compared to Conventional Epidural Morphine for Post-Cesarean Pain Anesth. Analg., July 1, 2007; 105(1): 176 - 183. [Abstract] [Full Text] [PDF]

				T. T. Horlocker, S. L. Kopp, M. W. Pagnano, and J. R. Hebl Analgesia for total hip and knee arthroplasty: a multimodal pathway featuring peripheral nerve block. J. Am. Acad. Ortho. Surg., March 1, 2006; 14(3): 126 - 135. [Abstract] [Full Text] [PDF]

				R. Sinatra Opioid Analgesics in Primary Care: Challenges and New Advances in the Management of Noncancer Pain J Am Board Fam Med, March 1, 2006; 19(2): 165 - 177. [Abstract] [Full Text] [PDF]

				E. R. Viscusi Emerging Techniques in the Management of Acute Pain: Epidural Analgesia Anesth. Analg., November 1, 2005; 101(5S_Suppl): S23 - 29. [Abstract] [Full Text] [PDF]

Anesthesia & Analgesia® is published for the International Anesthesia Research Society® by Lippincott Williams & Wilkins with the assistance of Stanford University Libraries' HighWire Press®. Copyright 2006 by the International Anesthesia Research Society. Online ISSN: 1526-7598   Print ISSN: 0003-2999