Ultra-Low fentanyl test may reveal hidden pain risk
NCT ID NCT00454259
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a very small dose of fentanyl can reveal how sensitive a person is to pain and whether they might develop worse pain after surgery. Researchers will give healthy volunteers either fentanyl or a placebo and measure their pain threshold using a mechanical stimulator. The goal is to see if this simple test could one day help doctors identify patients who need extra pain management before surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fentanyl
- What this could lead to
- If successful, this could lead to a simple test to predict which patients are at higher risk for severe pain after surgery.
- What could go wrong
- This is a small, early-phase study in healthy volunteers, not patients. The test may not work in real-world surgical settings or predict pain accurately.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
48 people
The number who actually took part.
- Start date
-
Mar 2007
- Finished
-
Aug 2007
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 40 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 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 Criteria: 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
CHU de Bordeaux Département d'Anesthésie-Réanimation II
Pessac, Hôpital Cardiologique, 33604, France
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Other studies related to the condition(s) this trial covers.
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