Abstract ID: A34

Abstract Title: SUSTAINED (UP TO 48 HOURS) PAIN RELIEF AFTER ABDOMINAL SURGERY WITH ENCAPSULATED EPIDURAL MORPHINE: PHASE III STUDY RESULTS

Poster Type: Poster


ABSTRACT BODY

Introduction: DepoMorphine is a novel formulation of encapsulated morphine given as a single epidural injection before surgery. It provides pain relief for up to 48 hours without need for an indwelling catheter or infusion pump. This study was designed to evaluate the analgesic efficacy and safety of DepoMorphine in lower abdominal surgery.

Methods: Adult patients (N=519) received an epidural injection of standard morphine (MS) 5 mg (active comparator) or DepoMorphine 5 (dose control), 10, 15, 20, or 25 mg before surgery. The primary efficacy end point was a linear dose-response relationship comparing the total intravenous (IV) fentanyl (via patient-controlled analgesia [PCA]) used through 48 hours. Additionally, pain intensity through 48 hours was measured using the visual analog scale at rest (VAS-R) and with activity (VAS-A).

Results: There was a dose-related reduction in the need for postoperative fentanyl through the 48-hour study period (Figure 1). In addition, mean (±SD) postoperative fentanyl use through 48 hours was lower in the pooled higher-dose DepoMorphine (10-25 mg) group than in the DepoMorphine 5 mg and MS 5 mg groups (898±852 μg vs 1213±1079 μg and 1218±894 μg, respectively; P<.01 for overall treatment vs DepoMorphine 5 mg and MS 5 mg groups). At 48 hours, no supplemental fentanyl was required in 15% of pooled higher-dose DepoMorphine patients, 6% of DepoMorphine 5 mg patients, and 2% of MS patients (Table 1; P=.0023 for pooled higher-dose DepoMorphine group vs MS). In addition to lower postoperative fentanyl consumption with DepoMorphine, patients treated with the three highest doses of DepoMorphine showed significantly reduced pain intensity at rest versus those treated with DepoMorphine 5 mg and MS (P<.01 for overall treatment vs DepoMorphine 5 mg and MS 5 mg groups). Twenty and 25 mg DepoMorphine doses were also associated with significant reductions in pain intensity with activity vs MS (P=.0384 and P=.0106, respectively).
When data were analyzed by patient age, those ≥65 years who received DepoMorphine 15 mg used less fentanyl than younger patients who received DepoMorphine 20 mg (Table 2).
DepoMorphine was generally well tolerated. Except for higher rates of pruritus and urinary retention in the DepoMorphine vs MS patients (54% vs 39% [P=.0301] and 9% vs 3% [P=.0346], respectively; P<.05), adverse events were similar across study groups. The most common events in all groups were nausea (66%), pruritus (51%), pyrexia (33%), vomiting (25%), and hypotension (22%). Three percent of DepoMorphine-treated patients (highest rate in the 25 mg group) and 2% of MS-treated patients experienced respiratory depression (P=NS); these patients were treated with an opioid antagonist.

Conclusion: DepoMorphine use resulted in significantly less IV PCA fentanyl use and improved pain control in the postoperative period.

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

A34_Table 1.doc

A34_Table 2 and Figure 1 caption.doc

A34_Fig. 1 12-23-031.tif

Reg Anesth Pain Med 2004; 29(2):A34