Clinical trial NCT03021083: IONSYS Feasibility Study
Official title: Evaluating the Feasibility of Using Transdermal Patient-controlled Fentanyl After Spinal Fusions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Spinal Injury
Keywords: Lumbar multi-level fusions
Patient Controlled Analgesia
Fentanyl
Opioid Analgesia
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
Collaborators: name: The Medicines Company
First posted: 2017-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility 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

Primary outcomes:
measure: Feasibility of IONSYS system
timeFrame: Day 2 following surgery for each patient
measure: NRS Pain Scores
timeFrame: Day 1 following surgery for each patient
Secondary outcomes:
measure: Day of eligibility for discharge,
timeFrame: Up to 1 week after surgery
measure: A Oswestry Back Pain Disability Index questionnaire
timeFrame: 6 weeks after surgery at the Post-Op Office Visit
measure: Level of Sedation
timeFrame: POD1
measure: Presence of Nausea of Vomiting
timeFrame: POD1 and POD2 after surgery
measure: Satisfaction Survey
timeFrame: Up to 1 week
Other outcomes:
Locations:
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Michael Urban, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fletcher D, Martinez V. Opioid-induced hyperalgesia in patients after surgery: a systematic review and a meta-analysis. Br J Anaesth. 2014 Jun;112(6):991-1004. doi: 10.1093/bja/aeu137.
citation: White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005 Nov;101(5 Suppl):S5-S22. doi: 10.1213/01.ANE.0000177099.28914.A7.
citation: Scott LJ. Fentanyl Iontophoretic Transdermal System: A Review in Acute Postoperative Pain. Clin Drug Investig. 2016 Apr;36(4):321-30. doi: 10.1007/s40261-016-0387-x.
citation: Mayes S, Ferrone M. Fentanyl HCl patient-controlled iontophoretic transdermal system for the management of acute postoperative pain. Ann Pharmacother. 2006 Dec;40(12):2178-86. doi: 10.1345/aph.1H135.