Clinical outcome study in postoperative pain management to demonstrate the efficacy and safety of IONSYS (fentanyl ITS Iontophoretic Transdermal System) in daily clinical practice and to assess its convenience (IPAC) - IPAC

Phase 1

Conditions: moderate to severe acute pain in postoperative patients who have undergone elective spine or orthopaedic surgery

Registration Number: EUCTR2008-002074-35-BE

Lead Sponsor: Janssen-Cilag N.V./S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Patients must satisfy the following criteria to be enrolled in the study:
1. Adult, aged 18 or older, male or female.
2. American Society of Anaesthesiology (ASA) pre-operative physical status I, II, or III (Attachment 1).
3. If the patient is female and of childbearing potential, she must have a negative pregnancy test at hospital admission.
4. Patients who will undergo elective spine or orthopaedic surgery.
5. Patients who are expected to have moderate or severe pain requiring parenteral opioids for at least 48 hours after surgery.
6. Patients who are capable of understanding and cooperating with the requirements of the study and operating fentanyl ITS.
7. Patients who have signed and dated the informed consent to participate in the study during the preoperative assessment.
8. Patients who have been admitted to the PACU after general anaesthesia, spinal anaesthetic of < 4 hours duration of action or epidural anaesthesia. Patients with epidural or regional anaesthesia will only be included if the provided analgesia was short lasting and was only given for the period of surgery and not for the period in the recovery room.
9. Patients who are alert and breathing spontaneously for at least 30 minutes in the PACU; respiratory rate 10 to 24 breaths per minute; patients must be able to answer questions and follow commands.
10. Patients with a pain score less than or equal to 4 out of 10 on a Numerical Rating Scale (NRS) at movement of the operated limb or body region, after titration to comfort according to current postoperative procedures.
11. Patients who are expected to remain hospitalised for at least 48 hours postoperatively.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Potential patients who meet any of the following criteria will be excluded from participating in the study:
1. Patients with a history of allergy or hypersensitivity to fentanyl and/or an allergy/hypersensitivity to skin adhesives and/or cetylpyridinium chloride.
2. Patients who are known or suspected to be strong opioid dependent, or who have a too high need for strong opioids.
3. Patients with a history of opioid dependence before the start of the study, defined as meeting any of the criteria for substance dependence specified in Attachment 2.
4. Patients who are known or suspected to have abused any drug substance or alcohol.
5. Patients with chronic pain disorder (DSM-IV 307.80/89 –
ICD 10: F45.4).
6. Patients with active systemic skin disease or active local skin disease that precludes fentanyl ITS application.
7.Patients known to have any of the following:
·severe chronic obstructive respiratory symptoms;
·susceptibility to present respiratory depression (possible synergistic effect associated with CNS drugs);
·patients who have a coexisting medical condition, (possibly with chronic pain of another organ) that is likely to interfere with study procedures.
Remark: -use of muscle relaxants is allowed (during the course of the general anaesthesia);
-use of anti-depressants/anxiolytics is allowed provided that they were taken for the same indication before surgery;
-the use of monoamineoxidase-inhibitors (MAO inhibitors) is not allowed during (or 14 days prior to) treatment with fentanyl ITS.
8. Women who are pregnant, breast feeding, or planning to breast feed within 7 days of last dose of study drug.
9. Patients who have taken any investigational drug or used an experimental medical device within 30 days before the start of the study or are currently enrolled in another investigational drug study.
10. Patients who received regular treatment with transdermal strong opioids within 14 days prior to surgery.
11. Patients who have received peri-operative administration of opioids other than morphine, fentanyl, sufentanil, alfentanil or remifentanil.
Exception: If there are no medical contraindications, one dose of meperidine, up to 50 mg IV, is allowed within 30 minutes of arrival in the PACU for treatment of shivering.
12. Patients who need postoperatively very high doses of opioids for pain control (more than 40 mg morphine/h equivalent or more than 60 mg pritramid to reach comfort zone (NRS £ 4)) or when more than 6 hours have elapsed since the patient arrived in the PACU.
13. Patients whose postoperative pain is managed with IV PCA or EPI PCA or CEI (continuous epidural infusion).
14. Patients whose postoperative pain would normally be managed with oral or non-opioid analgesia during the first 48 hours.
15. Patients who are being treated in the intensive care unit.
16. Patients who will probably require additional surgical procedures within 72 hours.
17. Patients who are intubated or have a laryngeal mask airway (LMA) at the time of final screening assessments (T0).
18. Patients who are employees of the investigator or the institution who have direct involvement in the study or other trials under the direction of the investigator.