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Sponsored by: |
University Hospital, Bordeaux |
---|---|
Information provided by: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00454259 |
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 period. NMDA receptor antagonists succeed in reducing this pain sensitization process. Recent studies show that in pain and opioid-experienced rats (POER) fentanyl ultra low doses do not induce analgesia, as observed in naive rats, but hyperalgesia. This is the first demonstration that a drug can induce opposite effect depending on individual history. We also observed a strong correlation between this hyperalgesic response in POER and the intensity of hyperalgesia they develop later, after inflammatory or surgical pain. The main aim of this study is to measure the dose effect response to fentanyl "ultra low doses" on human volunteer's nociceptive threshold, to determine if such an opposite response profile can be revealed.
Condition | Intervention | Phase |
---|---|---|
Pain, Postoperative |
Drug: Fentanyl/Placebo injection |
Phase IV |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Dose Comparison, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Fentanyl Ultra Low Doses Effects on Human Volunteer's Nociceptive Threshold. Towards a Simple Pharmacological Test Able to Predict Pain Vulnerability, Post Operative Hyperalgesia Development Risk? |
Enrollment: | 48 |
Study Start Date: | March 2007 |
Study Completion Date: | August 2007 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
0,5 µg/kg
|
Drug: Fentanyl/Placebo injection
Ultra low dose intravenous injection
|
2: Experimental
0,05 µg/kg
|
Drug: Fentanyl/Placebo injection
Ultra low dose intravenous injection
|
3: Experimental
0,005 µg/kg
|
Drug: Fentanyl/Placebo injection
Ultra low dose intravenous injection
|
4: Placebo Comparator
NaCl 0,9 %
|
Drug: Fentanyl/Placebo injection
Ultra low dose intravenous injection
|
Inclusion criteria :
In both groups:
In "operated" group:
- At least one history of peripheral surgery under general anesthesia with opioid in the past five years
Exclusion criteria :
In both groups:
In "healthy" group:
- Any history of general anesthesia or surgery
Ages Eligible for Study: | 18 Years to 40 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
In both groups:
In "operated" group:
Exclusion Criteria:
In both groups:
In "healthy" group:
France, Hôpital cardiologique | |
CHU de Bordeaux Département d'Anesthésie-Réanimation II | |
PESSAC Cedex, Hôpital cardiologique, France, 33604 |
Study Director: | Philippe RICHEBE, Dr | University Hospital, Bordeaux |
Principal Investigator: | Gérard JANVIER, PHD | University Hospital, Bordeaux |
Principal Investigator: | Claude DUBRAY, PHD | University Hospital, Bordeaux |
Principal Investigator: | Alain ESCHALIER, PHD | University Hospital, Bordeaux |
Principal Investigator: | jean DUALE CHRISTIAN, Dr | University Hospital, Bordeaux |
Principal Investigator: | Gisèle PICKERING, Dr | University Hospital, Bordeaux |
Responsible Party: | University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director ) |
Study ID Numbers: | CHUBX 2006/08 |
Study First Received: | March 29, 2007 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00454259 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Postoperative Hyperalgesia Human volunteer Fentanyl |
Randomized Controlled Trial Pain chronicisation Predictive test |
Signs and Symptoms Fentanyl Postoperative Complications |
Pain Hyperalgesia Pain, Postoperative |
Anesthetics, Intravenous Physiological Effects of Drugs Anesthetics Central Nervous System Depressants Narcotics Pharmacologic Actions Adjuvants, Anesthesia Pathologic Processes |
Sensory System Agents Anesthetics, General Therapeutic Uses Analgesics Peripheral Nervous System Agents Central Nervous System Agents Analgesics, Opioid |