NCT03021083

IONSYS Feasibility Study

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed description

Following posterior spinal fusions, many patients are treated with analgesics or other modalities for prolonged periods before choosing the surgical alternative. In addition, the narcotic-based anesthetic required for the procedure may induce postoperative hyperalgesia (1). Inadequate treatment of this pain can result in prolonged hospitalization, cardiopulmonary complications, and poor surgical outcome (2). Pain during the immediate postoperative period is usually managed with IV narcotic PCA and then transitioned to a combination of long-acting and short-acting oral analgesics. Because of the requirement for continuous carrier fluid infusion, cumbersome pump technology restricting mobility and supervision by a dedicated pain team to control programming of the pump, the PCA modality is often discontinued prior to all the patients' pain needs being met. The investigators' most recent study evaluated the addition of pregabalin to the pain regimen after spinal fusions. The study found that after the removal of the PCA modality, these patients had considerable pain during physical therapy (PT), and their pain was not improved with the addition of pregabalin. The IONSYS system might alleviate some of the problems encountered with conventional PCA systems (3,4). The system is an iontophoretic transdermal (needleless) system preprogrammed to deliver upon activation 40 mcg fentanyl over a 10-minute period, with up to 6 doses per hour. The system performs for 24 hours. The drug is embedded in a matrix gel and is only delivered when a current is propagated between the two poles of the system. Other than the usual narcotic side effects, the only specific side effect is a local dermatological reaction to the patch (5% had a rash, which cleared after removal). The system was designed with fentanyl, since hydromorphone cannot be incorporated in this type of matrix. Unlike hydromorphone, fentanyl is quick acting and doesn't hang around. The in-house chronic pain service currently puts many of their patients on IV fentanyl, because of the belief that it works when they have pain but is quickly metabolized.

Conditions

• Spinal Injury

Interventions

Type	Name	Description
DEVICE	IONSYS Patch	Patient controlled transdermal fentanyl patch, IONSYS, applied to patient in place of a PCA.

Timeline

• Start date: 2017-11-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2017-01-13
• Last updated: 2022-04-14

Regulatory

• FDA-regulated device study