Evaluating the Feasibility of Using Transdermal Patient-controlled Fentanyl After Spinal Fusions

• Status: Not yet recruiting
• Trial end date: 0000-00-00
• Target enrollment: 10
• Participant gender: All

Summary

The treatment of postoperative pain continues to be a challenge after posterior spinal fusions. There is considerable evidence demonstrating that a multi-modality approach including patient controlled analgesia (PCA) with opioids for postoperative pain management compared to conventional opioid analgesia provides a greater analgesic effect even when the amount of opioids consumed is similar between both groups. However, the PCA modality is often discontinued prior to all the patients' pain needs being met. The IONSYS system uses the concept of PCA-delivered narcotics and may be used for postoperative pain management.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Collaborator: The Medicines Company
• Treatments: Fentanyl
• Last Updated: 2017-01-11

Criteria

Inclusion Criteria:

• Patients 18-70 years old undergoing elective multi-level lumbar-sacral posterior spinal fusions

Exclusion Criteria:

• Chronic pain patients taking more than 20-mg equivalents of oxycodone daily

• Allergy to either hydromorphone or fentanyl

• Other chronic orthopedic pain complaints, which will confound the results of the study

• Issues with cognitive ability