|- candidate number||14090|
|- NTR Number||NTR3769|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-dec-2012|
|- Secondary IDs||P12.252 LUMC|
|- Public Title||Intra-subject variability in pain scoring and the consequences for analgesia treatment.|
|- Scientific Title||Intra-subject variability in pain scoring and the consequences for analgesia treatment.|
|- hypothesis||Healthy volunteers and patients with a high variability in pain scores have a high probability to experience pain relief from alfentanil opposed to volunteers and patients with a low variability in pain scores.|
|- Healt Condition(s) or Problem(s) studied||Acute pain, Chronic pain, Analgesia, Pain relief|
|- Inclusion criteria||Volunteer inclusion criteria:|
1. Healthy subjects of either sex between the age of 18 and 75;
2. Being able to give written informed consent.
Patient inclusion criteria:
1. Patients diagnosed with fibromyalgia or peripheral polyneuropathy according to the guidelines of the IASP or other professional pain societies (e.g., Netherlands Society of Anesthesiologists); or patients scheduled for elective abdominal surgery with post-operative PCA or PCEA;
2. A pain score of 5 or higher for chronic pain patients;
3. Age between 18 and 75 years;
4. Being able to give written informed consent.
|- Exclusion criteria||Patient and volunteer exclusion criteria:|
1. Unable to give written informed consent;
2. Medical disease such as pulmonary, renal, liver, cardiac, gastro-intestinal, vascular
3. Allergy to study medication;
4. Use of strong opioids;
5. Use of benzodiazepines;
6. History of illicit drug abuse or alcohol abuse;
7. History of psychosis;
9. Raised intracranial pressure;
10. Pregnancy and/or lactation.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||2-jan-2013|
|- planned closingdate||2-dec-2013|
|- Target number of participants||80|
|- Interventions||Analgetic drug (alfentanil = 100ng/ml) infusion. Subjects will score thermal and electrical pain before and during alfentanil and placebo infusion (crossover design). We will assess whether the variability in pain scores prior to infusion can predict the amount of analgesia by alfentanil.|
|- Primary outcome||Pain scores (NRS).|
|- Secondary outcome||Variability in pain scores (NRS).|
|- Timepoints||Measurements by the VAS or NRS for pain. To measure variability 10 scores will be taken. This will be done 2 times, under placebo and under alfentanil condition.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| L.C.J. Oudejans|
|- CONTACT for SCIENTIFIC QUERIES|| L.C.J. Oudejans|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Leiden University Medical Center (LUMC)|
|- Brief summary||Predicting the analgesic effect of pain medication is an important topic in chronic pain research, especially in the field of neuropathic pain. A recent finding of major interest was that the amount of pain relief produced by capsaicine patches could be predicted by the amount of variability of the pre-treatment spontaneous pain scores of the patients. Therefore, we want to further explore the predictability of pre-treatment pain variability on the probability to experience pain relief. To this end we will determine variability on experimentally induced heat and electrical pain stimuli to determine its predictive potential for opioid-induced analgesia (i.e. alfentanil). Furthermore, variability tests will be repeated after opioid administration to evaluate the effect of opioids on pain variability.
The aims of the study are:
1. To evaluate individual pain variability in the study groups;
2. To evaluate the predictive properties of pain variability on alfentanil analgesia;
3. To evaluate the effect of alfentanil on pain variability.
|- Main changes (audit trail)||28-3-2014: Most important changes in the Vapaana protocol:
• Quantitative Sensory Testing (QST) and corneal confocal microscopy measurements were added to the protocol for fibromyalgia patients.
• A group of 40 obese patients (BMI > 35) was added to the patient groups in the protocol, and their measurements include QST as is done in the fibromyalgia group.
• Outcome measures are the QST data (as described by Rolke et al. 2006). - AB|
|- RECORD||12-dec-2012 - 28-mrt-2014|