Persistent postsurgical pain/Chronic postoperative pain
Conditions
Interventions
Trade Name: Ultiva
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Remifentanil
Other descriptive name: Remifentanil hydrochloride
Concentration unit: mg milligra
Sponsors
Wilhelminen hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate analgesic effects of a one-hour target-controlled infusion of the ultra-short opioid receptor agonist remifentanil in patients suffering from peristent postsurgical pain.;Secondary Objective: To investigate predictors of treatment response. To investigate sensory changes after treatment.;Primary end point(s): Pain (NRS 0-100, “maximum pain over the past 24 hours”) at seven days after treatment (based on patient’s report).;Timepoint(s) of evaluation of this end point: seven days after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain rating (spontaneous pain at the moment at rest, spontaneous pain at the moment on movement, average pain in the past 24 hours, maximum pain in the past 24 hours, average pain over the past week, maximum pain over the past week) difference after treatment Pain ratings (spontaneous pain at the moment at rest, spontaneous pain at the moment on movement, average pain in the past 24 hours, maximum pain in the past 24 hours, average pain over the past week, maximum pain over the past week) over time Mechanical pain sensitivity (MPS) in the area of maximum pain in the responder group Quality of life in the responder group after treatment Predictors of response;Timepoint(s) of evaluation of this end point: Baseline, One day after treatment, seven days after treatment, one month after treatment | — |
Countries
Austria
Contacts
Public ContactDepartment of Anesthesia
Wilhelminen hospital
Outcome results
None listed