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single epidural dose ofmorphine sulfate extended-release liposome injectio provides 36h ortho and abd

MD Consult - Drug Information

Sustained-release morphine controls post-op pain for 2 days

October 27, 2004


By Karla Gale

NEW YORK (Reuters Health) - A single epidural dose of DepoDur (morphine sulfate extended-release liposome injection; Endo Pharmaceuticals) provides sustained pain relief after orthopedic or lower abdominal surgery, according to studies presented Tuesday at the American Society of Anesthesiologists' Annual Meeting in Las Vegas.

"Patient pain was better controlled and patients were functioning better -- to move around postoperatively -- which is important to avoid complications and to improve functional outcomes," co-presenter Dr. Gavin Martin said in an interview with Reuters Health.

"Total IV narcotic use was significantly reduced; pain scores at rest and with activity for up to 36 hours were significantly better; and time to first onset need of IV narcotic was prolonged against placebo and against morphine," he added.

In a randomized, double-blind dose-ranging study, Dr. Martin, at Duke University Medical Center in Durham, North Carolina, and colleagues compared the efficacy and safety of DepoDur after lower abdominal surgery.

Patients undergoing lower abdominal surgery were assigned single-dose injections of DepoDur 5 to 25 mg or morphine sulfate 5 mg as a control medication (n = 487, 70-86 patients/group), administered approximately 30 minutes before surgery. After surgery, patients were permitted to self-administer fentanyl IV through a patient-controlled analgesia device as rescue medication.

The amount of fentanyl used during the next 48 hours decreased linearly as the dose of DepoDur increased (p = 0.0002 for trend). Approximately 15% of patients given 10 mg DepoDur or more, versus 2% of those administered the control drug, were able to completely forgo postoperative rescue medication.

Pain intensity had been measured throughout the 48-hour period using a 100-mm visual analog scale. Those given DepoDur 15, 20 or 25 mg exhibited significantly less pain at rest or with activity compared with those given the control medication.

A second study evaluated DepoDur 20 mg or 30 mg versus sham epidural, administered 30 minutes prior to knee arthroplasty (n = 168).

Total supplemental opioid usage was three- to four-times lower in the DepoDur group.

During both trials, adverse effects were consistent with epidural opioid treatment, the presenters note. The incidence of pruritus and urinary retention were more frequent in the DepoDur groups (54% versus 39% and 9% versus 3%, respectively). The investigators observed no increase in the incidence of neurological events. The most common serious adverse event was respiratory depression.

DepoDur is approved by the U.S. Food and Drug Administration at doses of 10, 15 or 20 mg for the treatment of pain following major surgery.

posted by PainNP @ 10:11 PM