Ionsys Mobilisation: Patient Analgesia Control Trial (IMPACT).

Condition(s) targeted: Hysterectomy; Mobility; Pain, Postoperative; Arthroplasty, Replacement, Hip

Intervention: Ionsys (Drug); Morphine IV PCA (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Janssen-Cilag Ltd.

Official(s) and/or principal investigator(s):
Janssen-Cilag Ltd. Clinical Trial, Study Director, Affiliation: Janssen-Cilag Ltd.

Overall contact:
Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

The purpose of this study is to evaluate the mobilisation characteristics, clinical use, safety and Ease of Care (EOC) of a Fentanyl Iontophoretic Transdermal Patient Conrolled Analgesia (PCA) system (Ionsys) which delivers 40 mcg Fentanyl per on demand dose and morphine Intravenous (IV) PCA for management of acute moderate to severe post-operative pain in patients who have undergone elective major abdominal (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty). Morphine IV PCA will be prescriber as per routine practice, up to a maximum total of 20mg morphine per 2 hours.

Official title: Comparison of Ionsys and Routine Care With Morphine IV (Intravenous) PCA in the Management of Early Post-Operative Mobilisation, Ability to Mobilise and in Time to Fitness For Discharge.

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Primary outcome: Patient's evaluation of their ability to mobilise post-operatively. Assessed hourly during the first 6 hours. If the patient is still receiving study treatment, assessments will be made at hours 8, 12, 24, 48, 72 hours & when deem Fit For Discharge

Secondary outcome: Patient's Pain Rating, Nurse Ease of Care, Patient Global Assessment of Method of Pain Control, Fitness for Discharge, Actual Discharge Time, PCA Use, Anti Emetic Use, Non-opioid Analgesic Use and Suspected Technical Failures

Detailed description: This is a randomised (study medication assigned by chance), multicentre, open-label, active-controlled, parallel group study. Approximately 200 patients with expected acute moderate to severe post operative pain after an elective major abdominal (abdominal hysterectomy) or orthopaedic surgery (unilateral primary total hip arthroplasty) will be included. Eligible patients will be randomised to receive either Ionsys or morphine IV PCA. The primary effectiveness endpoint is the patient's ability to mobilise assessed using three validated questions at the time of study treatment discontinuation. This will be summarised by treatment group at each time point post dose, with the assessment at the time of study treatment discontinuation analysed as detailed below. The difference in mobility between the two treatment groups will be assessed using an Analysis of Covariance (ANCOVA) adjusted for the indication (type of surgery). Treatment difference will be presented with a 95% confidence interval. The secondary endpoints will be: Ability to mobilise by surgery type; Pain intensity measured on an 11-point scale; Time to fitness for discharge; time to final discharge; Nurse Ease Of Care questionnaire; Patient global assessment of method of pain control; use of post-operative non-opioid analgesics; use of post-operative antiemetics; use of rescue morphine. Patient safety will be assessed using vital signs, adverse events, concomitant medications and non routine events.

Ionsys: iontophoretic transdermal system, delivers 40 mcg fentanyl per on-demand dose up to a maximum of 240 mg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24-hour period. A new system will be applied every 24 hours, if required. If the patient has used 80 doses in less than 24 hours a new system can be applied earlier. Morphine IV PCA: Morphine bolus doses will be delivered as per local standard of care. Treatment duration will be 24-72 hours.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients, after an elective abdominal hysterectomy or unilateral primary total hip

arthroplasty

- American Society of Anesthesiology (ASA) pre-operative physical status I or II

- Expected to have acute moderate to severe post-operative pain requiring parenteral

opioids via PCA for at least 24 hours after surgery

- Patient able to provide written consent

- General anaesthesia, spinal anaesthetic of less than or equal to 4 hours duration of

action or epidural anaesthesia (single administration only)

- Respiratory rate 10 to 24 breaths per minute

- SpO2 ≥95% (with or without supplemental oxygen) and Pain score less than or equal to 4

out of 10 on a NRS after titration to comfort with IV morphine

Exclusion Criteria:

- Revision of a previous hip arthroplasty

- Surgery secondary to malignancy or trauma

- History of psychological opioid dependence and/or known or suspected to be opioid

dependent

- Known to be opioid tolerant (in the opinion of the investigator) before entering the

study

- Persistent somatoform pain disorder (ICD-10 code F45. 4)

- Severe chronic obstructive respiratory symptoms susceptibility to respiratory

depression, moderate to severe renal dysfunction

- Peri-operative administration of opioids other than morphine, fentanyl, sufentanil,

alfentanil or remifentanil

- Require high doses of opioids to control their pain (more than 40 mg morphine IV)

during titration to comfort, or more than 6 hours have elapsed since the patient arrived in the recovery room or Monoamine oxidase inhibitors (MAOI) within 14 days pre-study

Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:, Email: info1@veritasmedicine.com

Salford M6 8HD, United Kingdom; Recruiting

Edinburgh University, Edinburgh EH16 4SA, United Kingdom; Recruiting
IAN POWER, Phone: +441312423136
IAN POWER, Principal Investigator

Llandough Hospital, Cardiff CF64 2XX, United Kingdom; Recruiting
Pr Judith HALL, Phone: +4402920743110
JUDITH HALL, Principal Investigator

Musgrave Park Hospital, Belfast BT9 7JB, United Kingdom; Recruiting
James Murray, Phone: +442890902209
JAMES MURRAY, Principal Investigator

Solihull B91 2JL, United Kingdom; Recruiting

Gartnavel General Hospital, Glasgow G12 0YN, United Kingdom; Recruiting
MICHAEL SERPELL, Phone: +441412113287
MICHAEL SERPELL, Principal Investigator

Liverpool L8 7SS, United Kingdom; Recruiting

To learn how to participate in this trial please click here.

Starting date: April 2008
Ending date: November 2008
Last updated: October 31, 2008