Abstract ID: A36

Abstract Title: PHASE III STUDY OF ENCAPSULATED EPIDURAL MORPHINE FOR POSTOPERATIVE PAIN CONTROL FOLLOWING TOTAL HIP ARTHROPLASTY

Poster Type: Poster


ABSTRACT BODY

Introduction: For orthopedic procedures, a single-dose morphine formulation that provides prolonged pain relief may simplify the technical aspects of postoperative analgesia and reduce the potential for complications associated with indwelling epidural catheters in anticoagulated patients. This study evaluated the analgesic efficacy and safety of DepoMorphine, an innovative, long-acting, single-dose, encapsulated formulation of morphine.

Methods: Adults (N=194) were randomized to receive an epidural injection of placebo or DepoMorphine 15, 20, or 25 mg prior to surgery. Postoperative breakthrough pain was controlled with intravenous (IV) fentanyl via a patient-controlled analgesia (PCA) pump. Total postoperative fentanyl consumption through 48 hours was the primary efficacy end point. Assessments included pain intensity (measured by the 100-mm visual analog scale at rest [VAS-R] and with activity [VAS-A] and categorical scores from 0=none to 3=severe at rest [CAT-R] and with activity [CAT-A]). Patient global assessments of pain control and adverse events were also assessed.

Results: Mean (±SD) fentanyl consumption was 75% lower in the DepoMorphine (pooled data from 15, 20, and 25 mg groups) group versus placebo (510±708 μg vs 2091±1803 μg; P<.0001); higher doses of DepoMorphine were associated with greater reductions in fentanyl use through 48 hours. Median time to first postoperative fentanyl use was significantly delayed with DepoMorphine (Table 1). In addition, DepoMorphine (pooled data) eliminated the need for postoperative fentanyl in 46% of patients through 24 hours (placebo, 2%; P<.0001) and 25% through 48 hours (placebo, 2%; P=.001). DepoMorphine also improved pain control at rest and with activity versus placebo (Table 2). At 24 and 48 hours, more DepoMorphine-treated patients rated their pain control as "very good/good" vs placebo (90% vs 65% and 83% vs 67%, respectively; P<.0001 and P=.0223, respectively).
DepoMorphine was well tolerated. With the exception of vomiting and pruritus, which were more common in DepoMorphine patients (49% vs 19% and 46% vs 15%, respectively; P=.0024 and P=.0009, respectively), the incidence of opioid-related side effects was similar across groups. Respiratory depression was treated with an opioid antagonist. This event occurred in 6% of DepoMorphine 15 mg patients, 0% of DepoMorphine 20 mg patients, 5% of DepoMorphine 25 mg patients, and no placebo patients (P=NS).

Conclusion: This multicenter controlled trial demonstrated that DepoMorphine provided extended (48-hour) analgesia with a single dose. DepoMorphine significantly reduced pain scores and was well tolerated.

Acknowledgment: This study was supported by SkyePharma, Inc., San Diego, California. This abstract was supported by Endo Pharmaceuticals, Chadds Ford, Pennsylvania, with editorial assistance provided by Accel Healthcare Communications, Inc., New York, New York.

ATTACHED FILES

A36_Table 1.doc

A36_Table 2.doc



Reg Anesth Pain Med 2004; 29(2):A36