IONSYS Feasibility Study

NCT03021083 | Withdrawn Phase 4 DMC FDA Device

• 1 other identifier: 2016-803
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Spinal Injury

Keywords

Lumbar multi-level fusions; Patient Controlled Analgesia; Fentanyl; Opioid Analgesia

Outcome Measures

Primary Outcomes (2)

• Feasibility of IONSYS system

  1\. Nursing assessment regarding the ease of setup and initiation of the IONSYS system (With regard to setup and initiation of the IONSYS, on a scale of 0-10, where 0=worst and 10=best, how would the nurse rate the system?). This will be given to the nurse who sets up the device on DOS, and nurse who sets up the device on POD 1, and the day nurse on POD 2. An average score of 7 will be considered feasible.

  Day 2 following surgery for each patient

• NRS Pain Scores

  1\. NRS pain (0-10 scale) on first day after surgery (POD 1) during the afternoon session of PT. In a previous study on similar patients with IV PCA, we recorded mean pain scores of 4.6 during PT. Adequate pain control is delineated as NRS ≤ 3

  Day 1 following surgery for each patient

Secondary Outcomes (5)

• Day of eligibility for discharge,

  Up to 1 week after surgery

• A Oswestry Back Pain Disability Index questionnaire

  6 weeks after surgery at the Post-Op Office Visit

• Level of Sedation

  POD1

• Presence of Nausea of Vomiting

  POD1 and POD2 after surgery

• Satisfaction Survey

  Up to 1 week

Study Arms (1)

IONSYS Administration

EXPERIMENTAL

Patients who have elective multi-level spinal fusions under general anesthesia (who do not receive methadone) will be enrolled. In addition, all patients will receive Pepcid 20 mg, dexamethasone 10 mg, and ondansetron 4 mg. When patients will arrive in the post anesthesia care unit (PACU), pain will initially be controlled with IV hydromorphone to achieve an NRS score of 3 or less. Once transferred to the step down unit (SDU), the IONSYS patch will be applied. IONSYS should be utilized when they have pain, but rescue analgesia will be available. If severe pain continues, the chronic pain service will be consulted, to potentially change the medications. Patients will be assessed for pain at rest and with PT in the AM and PM of POD 1 and POD 2. The IONSYS system will be discontinued after 48 hours, and a total dose of fentanyl received per 24 hours will be recorded. PT milestones for discharge will be assessed on the afternoon of POD 1 and POD 2.

Device: IONSYS Patch

Interventions

IONSYS Patch DEVICE

Patient controlled transdermal fentanyl patch, IONSYS, applied to patient in place of a PCA.

Also known as: Patient Controlled Transdermal Fentanyl Patch

IONSYS Administration

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• The Medicines Company: collaborator

Related Publications (4)

• 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.

  PMID: 24829420 BACKGROUND

• 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.

  PMID: 16334489 BACKGROUND

• 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.

  PMID: 26968174 BACKGROUND

• 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.

  PMID: 17164395 BACKGROUND

MeSH Terms

Conditions

Spinal Injuries

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Study Officials

• Michael Urban, M.D.

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2016
• First Posted: January 13, 2017
• Study Start: November 1, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: April 14, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share