Clinical trial NCT02252458: Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?
Official title: Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers? A Prospective, Randomized, Double-blinded Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Opioid induced hyperalgesia
Fentanyl
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2014-09-30
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine whether two clinically sensible dose regimen of fentanyl (low dose vs. high dose) lead to different pain scores as measured by the nonverbal rating scale (NRS) in healthy volunteers at 4.5 to 6.5 hours after fentanyl application. Pain modalities tested will include transdermal electrical stimulation and cold pressor pain.

The investigators hypothesize that the high dose fentanyl group will have an increase of approximately 20% in the NRS.


Eligibility criteria: Inclusion Criteria:

* Healthy (ASA I-II) male volunteers
* Age \> 18 years
* BMI 18 - 25 kg/m2

Exclusion Criteria:

* Volunteers unable to give written informed consent
* Known drug allergies or intolerance to fentanyl
* Known drug allergies or intolerance to morphine and other opiates
* Recreational drug addiction or abuse
* Opiate use in the last month
* Volunteers taking confounding medication (analgesics, antihistamines, calcium or potassium channel blockers) in the last month
* History of motion sickness, neuropathy, chronic pain, neuromuscular or psychiatric disease
* Patients with renal failure (clearance \< 30 ml/min)
* obstructive sleep apnea syndrome (OSAS)
* Indication for Rapid Sequence Induction
* Patients not understanding German, French, Italian or English

Primary outcomes:
measure: COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.
timeFrame: 4.5 to 6.5h after begin of fentanyl infusion
Secondary outcomes:
measure: Pain as measured by the nonverbal rating scale
timeFrame: 0-2h after begin of fentanyl infusion at 15 min intervals
measure: cold pressor pain
timeFrame: at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion
measure: Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)
timeFrame: -15min, -10min, -5 min, 0 min, 15 min, 30 min, 45min, 1h, 1h 30min, 2h, 4h 30min, 4h 35min, 4h 40min, 4h 45min, 5h, 5h 30min, 6h, 6h 30min after begin of infusion
measure: pupillary dilation response
timeFrame: baseline and at 4.5h after begin of infusion
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Department of Anesthesia, University of Basel Hospital
Study officials:
affiliation: University Hospital Basel, Dep. of Anesthesia
name: Wilhelm Ruppen, PD Dr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mauermann E, Blum CA, Lurati Buse G, Bandschapp O, Ruppen W. Time course of copeptin during a model of experimental pain and hyperalgesia: A randomised volunteer crossover trial. Eur J Anaesthesiol. 2017 May;34(5):306-314. doi: 10.1097/EJA.0000000000000592.