Long-term intrathecal opioid therapy with a patient-activated, implanted delivery system for the treatment of refractory cancer pain.
The present study evaluated the safety and efficacy of patient-activated delivery of intrathecal morphine sulfate boluses delivered by way of a novel internalized intrathecal delivery system. Patients with refractory cancer pain or uncontrollable side effects were enrolled at 17 US and international sites in this prospective, open-label study. Pain relief, reduction in systemic opioid use, and reduction in opioid-related complications were analyzed both individually and together as a measure of overall success. One hundred forty-nine patients were enrolled and 119 were implanted. Average numeric analog scale pain decreased from 6.1 to 4.2 at 1 month and was maintained through month 7 (P <.01) and through month 13 (P <.05). Systemic opioid use was significantly decreased throughout the study (P <.01). Significant reduction in the opioid complication severity index was demonstrated at all 4 follow-up visits (P <.01). Overall success (>/=50% reduction in numeric analog scale pain, use of systemic opioids, or opioid complication severity index) was reported in 83%, 90%, 85%, and 91% of patients at months 1, 2, 3, and 4, respectively. This study demonstrated that patients with refractory cancer pain or intolerable side effects achieved better analgesia when managed with patient-activated intrathecal delivery of morphine sulfate via an implanted delivery system.
Rauck
Richard L
RL
Piedmont Anesthesia and Pain Consultants, PA, Winston-Salem, NC, USA. rrauck@papc.com
Cherry
David
D
Boyer
Michael F
MF
Kosek
Peter
P
Dunn
Joseph
J
Alo
Kenneth
K
D000368:Aged; D016058:Analgesia, Patient-Controlled; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004343:Drug Implants; D005260:Female; D006801:Humans; D007278:Injections, Spinal; D008134:Long-Term Care; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D009369:Neoplasms / Q000150:complications*; D010147:Pain Measurement; D010148:Intractable Pain / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies
D000701:Analgesics, Opioid; D004343:Drug Implants; D009020:Morphine