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| |  ASA: Sustained Release Morphine Controls Pain Following Hip Arthroplasty By Ed Susman SAN FRANCISCO, CA -- October 22, 2003 -- A single epidural injection of sustained-release morphine controlled pain post-operatively for 48 hours better than placebo in patients who underwent hip arthroplasty, researchers reported here October 14th at the 2003 Annual Meeting of the American Society of Anesthesiologists. "The bottom line here is that this product offers sustained pain relief with a single epidural injection, and it requires no catheterisation," said Dr. Eugene Viscusi, MD, director, acute pain management, Jefferson Medical College, Jefferson University, Philadelphia, Pennsylvania, United States. In a poster discussion session, Dr. Viscusi described the study in which 194 patients undergoing hip arthroplasty surgery were administered either the epidural delivery system, called DepoFoam, or a placebo. Fifty patients received a placebo, 51 patients received 15 mg of sustained-release DepoMorphine (SKY0401), 50 patients received the 20 mg dose and 49 patients were given 25 mg. The patients then underwent the surgery. Following surgery they were allowed to control their own pain using patient-controlled analgesia with intravenous fentanyl. "One-fourth of the patients receiving the DepoFoam with suspended morphine DepoMorphine did not require any further analgesia," Dr. Viscusi said. The greatest effect was seen in the middle dose of the investigational product -- 20 mg. In the first 24 hours, nearly half of patients taking the sustained-release morphine did not require pain medication, compared with less then 5% of patients who received a placebo before surgery (P<0.0001). In the 24 to 48 hours following surgery, about 40% of patients taking sustained-release morphine did not require any fentanyl, compared with about 5% of patients who initially received placebo (P<0.068). Overall, in the 48-hour period, 30% of patients on sustained-release morphine never needed self-administered fentanyl, compared with less than 5% of patients who received placebo (P<0.016). Dr. Viscusi said the results show a reduced effect with the 15 mg dose that equalled the effect achieved at the higher doses, leading him to suggest that the 20 mg dose will be used in clinical practice. He said a major impact of the one-shot delivery reflects current concerns regarding problems with use of in-dwelling catheters to deliver analgesia. Those problems include limited duration of analgesia, risk of infection and epidural haematoma associated with epidural catheters, especially in the presence of anticoagulants. Dr. Kenneth Drasner, MD, Director, Acute Pain Service, University of California, San Francisco, United States, said the anticoagulation issue and the risk of resulting haematomas have given impetus to development of delivery systems such as the DepoFoam/DepoMorphine product. "This system looks useful, but I think it has a way to go yet," he said. Dr. Terese Horlocker, MD, associate professor of anaesthesiology, Mayo School of Medicine, Rochester, Minnesota, United States, said questions still exist over how the new delivery system will work when used in combination with other analgesia, as is likely to occur in general practice. Dr. Viscusi said that SkyePharma, Inc., San Diego, California, United States, has filed for licensing of the epidural delivery system with the US Food and Drug Administration (FDA). DepoMorphine uses a novel sustained-release formulation, he said. DepoFoam technology consists of lipid vesicles that release morphine over an extended period of time. SkyePharma sponsored the study.
[Study title: Postoperative Pain Relief Following Hip Arthroplasty with Epidural. Abstract A-1120]
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