Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Hyperalgesia
In brief
The purpose of this study is to evaluate whether using ultra-low dose naloxone, an opioid antagonist, has the potential to block remifentanil-induced hyperalgesia and tolerance following surgery. There are 3 study groups: (1) low dose remifentanil (LO, 0.1 micrograms/kg/mL), (2) high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL), or (3) high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone). The hypothesis of the study is that occurrence of remifentanil-induced hyperalgesia (low score in mechanical pain threshold) in the HN group will be lower than in the HI group.
Key facts
- Study ID
- NCT03066739
- Run by
- University of California, Irvine
- People needed
- 8
- Starts
- 2023-02-25
- Expected to finish
- 2025-12-01
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects who provide written informed consent.
- Age 18 years old or older (no upper age limit for inclusion)
- Gender: male or female.
- Surgery: Posterior spinal fusions
You may not qualify if…
- Allergy to opiates
- Chronic pain other than the primary indication for surgery
- Psychiatric illness
- History of substance abuse problem including alcohol \&/or cannabis
- BMI > 35
- Subjects under 18 years of age.
- Subject without the capacity to give written informed consent. 8. Female subjects who are pregnant
Where it is running
- UC Irvine Medical Center — Orange, California, United States
Full record on ClinicalTrials.gov
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