Can Fentanyl Lead to Opioid-induced Hyperalgesia in Healthy Volunteers?

NCT02252458 | Completed DMC

• 1 other identifier: 2014-054
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Opioid induced hyperalgesia; Fentanyl

Outcome Measures

Primary Outcomes (1)

• COMPOSITE of pain scores as measured by the nonverbal rating scale (NRS) at 15 minute intervals within the timeframe specified below.

  4.5 to 6.5h after begin of fentanyl infusion

Secondary Outcomes (4)

• Pain as measured by the nonverbal rating scale

  0-2h after begin of fentanyl infusion at 15 min intervals

• cold pressor pain

  at -15min, 1h, 2h, 3h, 4h, 5h, 6h, 6h30min after begin of infusion

• Lab values (B-endorphin, fentanyl plasma Levels, potentially Adrenocorticotropic hormone (ACTH) / cortisol)

  -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

• pupillary dilation response

  baseline and at 4.5h after begin of infusion

Study Arms (2)

Fentanyl high dose

EXPERIMENTAL

Fentanyl 10mcg/kg of bodyweight

Drug: Fentanyl

Fentanyl low dose

ACTIVE COMPARATOR

Fentanyl 1mcg/kg of bodyweight

Drug: Fentanyl

Interventions

Fentanyl DRUG

Fentanyl high dose; Fentanyl low dose

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anesthesia, University of Basel Hospital

Basel, 4031, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 28106611 DERIVED

MeSH Terms

Interventions

Fentanyl

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Wilhelm Ruppen, PD Dr., MD

  University Hospital Basel, Dep. of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 30, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: January 9, 2015

Record last verified: 2015-01

Locations

CH (1)