A study to investigate the effects of the short-acting opioid drug Remifentanil applied one time over the course of one hour on pain in 24 patients suffering from chronic pain after an operatio

Phase 1

Active, not recruiting

• Conditions: Persistent postsurgical pain/Chronic postoperative pain; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2015-004517-24-AT
• Lead Sponsor: Wilhelminen hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-30
• Last Update Posted: 23 May 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

male or female
at least 18 years of age
suffering from pain of at least 40 on the NRS (0-100) – pain” being defined as maximum pain or average pain within the past 24 hours reported retrospectively by the patient
the chronic pain is a result of an operation – result of an operation” being defined as (I) (a) the patient was pain-free before the operation or (b) the pain problem was unchanged or worsened after the operation as indicated by the patient and (II) the patient answers the question Do you believe the operation is the or one of the causes of your pain” with Yes”
the operation took place at minimum three months and at maximum three years ago
body mass index between the 15th and 85th percentile
able to understand, read, and write German willing and able to give informed consent

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 12
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12

Exclusion Criteria

Patients with a known underlying disease causing this postsurgical pain
Patients suffering from pain where the site of maximum pain is impossible or difficult to access for QST measurements
Patients currently on analgesic or antitussive opioid therapy
Patients scheduled for an invasive procedure within the time-frame of the study
Patients scheduled for any other treatment for their chronic pain condition
Patients graded as ASA (American Society of Anesthesiologists) 4
Patients with a contraindication for undergoing general anesthesia
Patients suffering from any somatic pain which is stronger than to be treated pain
Patients suffering from: unstable hypertension, acute cardiac decompensation, cardiac valve dysfunction, pulmonary hypertension, relevant cardiac conduction disturbance (= second degree AV-block, anamnestic malignant arrhythmia (e.g. ventricular tachycardia, ventricular fibrillation)), bronchial asthma, chronic obstructive pulmonary disease (COPD) >GOLD II
Patients suffering from any known severe psychiatric condition
Patients with implanted cardiac converter or pacemaker
Pregnancy or breast-feeding
Known abuse of alcoholic beverages or any illegal drug
Known allergy against the interventional medication, against any of the drugs used for induction or maintenance of the anesthesia or against any study assessment devices
Currently enrolled in another clinical trial
Participation in a clinical trial in the 2 weeks preceding the study (except solely observational/non-interventional trials)
Unable or unwilling to give informed consent
Unable or unwilling to follow investigator’s instructions
Unable or unwilling to comply with study protocol
Patients suffering from any known medical conditions which may interact with study medication, study objectives, or compliance of subject with study tasks.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified