COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

IONSYS Feasibility Study (IONSYS Pilot)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03021083
Recruitment Status : Withdrawn (Contract not reached with sponsor)
First Posted : January 13, 2017
Last Update Posted : February 14, 2018
The Medicines Company
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Spinal Injury Device: IONSYS Patch Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluating the Feasibility of Using Transdermal Patient-controlled Fentanyl After Spinal Fusions
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IONSYS Administration

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
Patient controlled transdermal fentanyl patch, IONSYS, applied to patient in place of a PCA.
Other Name: Patient Controlled Transdermal Fentanyl Patch

Primary Outcome Measures :
  1. Feasibility of IONSYS system [ Time Frame: Day 2 following surgery for each patient ]
    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.

  2. NRS Pain Scores [ Time Frame: Day 1 following surgery for each patient ]
    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

Secondary Outcome Measures :
  1. Day of eligibility for discharge, [ Time Frame: Up to 1 week after surgery ]
    1. Day of eligibility for discharge, as assessed by a physical therapist's observation of a patient's ability to walk at least 20 feet and climb 4 stairs. Will be delineated as either AM or PM on a day following surgery, since PT is conducted twice daily.

  2. A Oswestry Back Pain Disability Index questionnaire [ Time Frame: 6 weeks after surgery at the Post-Op Office Visit ]
    An Oswestry Back Pain Disability Index questionnaire will be conducted at the first postoperative office visit to assess whether improved pain control in the hospital had an effect on the post-discharge recovery of the patient.

  3. Level of Sedation [ Time Frame: POD1 ]
    Level of sedation, as assessed by PT starting on POD1 at the initiation of PT using the University of Michigan sedation scale: (1) awake and alert; (2) minimally sedated; (3) moderately sedated; (4) deeply sedated; (5) unarousable

  4. Presence of Nausea of Vomiting [ Time Frame: POD1 and POD2 after surgery ]
    Assess whether the patient has post-operative nausea and vomiting (PONV)

  5. Satisfaction Survey [ Time Frame: Up to 1 week ]
    A satisfaction survey will be conducted prior to discharge from the hospital. It will include the following questions: (1) Was the patient's pain adequately treated? (Y/N); (2) What was the patient's worst pain level after surgery? (0-10 scale); (3) Was the IONSYS device explained? (Y/N); (4) Did the patient have side effects to the IONSYS? (Y/N); (5) Was the patient able to perform PT? (Y/N); (6) Overall satisfaction with IONSYS device (0-10 scale; 0=not satisfied; 10=most satisfied).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03021083

Sponsors and Collaborators
Hospital for Special Surgery, New York
The Medicines Company
Layout table for investigator information
Principal Investigator: Michael Urban, M.D. Hospital for Special Surgery, New York
Layout table for additonal information
Responsible Party: Hospital for Special Surgery, New York Identifier: NCT03021083    
Other Study ID Numbers: IONSYS #2016-803
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Hospital for Special Surgery, New York:
Lumbar multi-level fusions
Patient Controlled Analgesia
Opioid Analgesia
Additional relevant MeSH terms:
Layout table for MeSH terms
Spinal Injuries
Back Injuries
Wounds and Injuries
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General