Abstract ID: A37
Abstract Title: PHASE II STUDY OF LONG-ACTING ENCAPSULATED EPIDURAL MORPHINE FOR POSTOPERATIVE PAIN AFTER CESAREAN SECTION
Poster Type: Poster
ABSTRACT BODY
Introduction: Because pain following cesarean section often peaks on postoperative day 2, pain management could be improved with an analgesic lasting 48 hours. DepoMorphine, an innovative encapsulated formulation of morphine, provides therapeutically effective opioid levels for up to 48 hours from a single epidural injection given perioperatively. DepoMorphine may eliminate practical concerns related to the current use of epidural morphine, such as its short duration of action and the need for an indwelling catheter and an infusion pump to administer postoperative pain medication.
Methods: This multicenter, randomized study compared DepoMorphine with standard morphine (MS) following elective cesarean section under combined spinal epidural anesthesia. Parturients (N=75) received 12–15 mg bupivacaine with 10 μg fentanyl intrathecally, followed by a single epidural dose of either MS 5 mg or DepoMorphine 5, 10, or 15 mg after cord clamping. Total supplemental oral or intravenous (IV) opioid analgesic (measured in IV morphine-mg equivalents) consumption through 48 hours post-dose was the primary end point. Pain intensity was measured by the visual analog scale at rest (VAS-R) and with activity (VAS-A) through 48 hours.
Results: Mean (±SD) total supplemental opioid medication used through 48 hours was lower in the pooled DepoMorphine group (5+10+15 mg) versus MS (30±27 mg vs 47±34 mg; P<.05); Table 1 presents supplemental medication use by group. Mean use was also lower on postoperative day 2 with DepoMorphine 10 mg (12±9 mg) and 15 mg (11±21 mg) versus MS (20± 12 mg; P<.001 for pooled DepoMorphine group). Pain intensity scores at rest were lower among patients who received DepoMorphine compared to those treated with MS (P=.0007 with pooled data). With the two higher doses of DepoMorphine, pain intensity during activity was also lower versus MS (P<.001). In addition, more DepoMorphine patients rated their pain control as "good" or "very good": 79%, 79%, and 95% in DepoMorphine 5, 10, and 15 mg groups versus 72% in the MS group. Across treatment groups, there were no significant differences in adverse events and most were mild to moderate in severity. The most common adverse events were nausea (44%), pruritus (43%), and vomiting (19%). One DepoMorphine patient (15 mg) and no MS patients experienced respiratory depression (P=NS); the DepoMorphine patient was treated with naloxone.
Conclusion: DepoMorphine is a promising long-acting, single-dose epidural analgesic for the management of postoperative cesarean section pain.
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
Reg Anesth Pain Med 2004; 29(2):A37