Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia

IRB # 20141345

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.

2023-02-25

2023-12-31

2024-12-31

Recruiting

Early phase I

105

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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2023-07-06