Status:
COMPLETED
Fentanyl Ultra Low Doses Effects on the Nociceptive Threshold
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Pain, Postoperative
Eligibility:
MALE
18-40 years
Phase:
PHASE4
Brief Summary
Exaggerated pain and hyperalgesia are major issues after surgery and can lead to chronic pain. Opioid are parts of pain sensitization processes but remain absolutely necessary in the intraoperative pe...
Detailed Description
* Principal Objective : "Evaluate fentanyl "ultra low doses" effects on human volunteer's nociceptive threshold depending on their prior pain and opioid experience." * Secondary Objective : "Confirm t...
Eligibility Criteria
Inclusion
- In both groups:
- 18-40 years old male volunteer
- Weight: 60 to 85 kg
- ASA score: 1
- Informed consent obtained from the patient
- In "operated" group:
- At least one history of peripheral surgery under general anesthesia with opioid in the past five years.
Exclusion
- In both groups:
- The patients do not accept inclusion to the study
- Drug or alcohol abuse history
- Chronic use of analgesic drugs or history of chronic pain
- Analgesic or opioid consumption within the 12hs preceding the fentanyl or placebo injection
- Neurological and/or psychiatric disorder, inability to give informed consent
- Psychological trauma within the two year preceding the inclusion
- Any contraindication to fentanyl use
- Use of any medication interacting with fentanyl
- Exclusion period from the national healthy volunteer register
- In "healthy" group:
- Any history of general anesthesia or surgery
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00454259
Start Date
March 1 2007
End Date
August 1 2007
Last Update
June 3 2015
Active Locations (1)
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1
CHU de Bordeaux Département d'Anesthésie-Réanimation II
Pessac, Hôpital Cardiologique, France, 33604