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

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ClinicalTrials.gov Identifier: NCT03066739
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
University of California, Irvine

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Hyperalgesia Drug: Remifentanil Drug: Remifentanil+ Placebo Drug: Remifentanil +ultra-low dose naloxone Phase 2

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ultra-low Dose Naloxone on Remifentanil-Induced Hyperalgesia
Estimated Study Start Date : July 2021
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LO-low dose remifentanil
low dose remifentanil (LO, 0.1 micrograms/kg/mL),
 Drug: Remifentanil
0.1 micrograms/kg/mL
Other Name: LO
Active Comparator: HI-high dose remifentanil with placebo
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
 Drug: Remifentanil+ Placebo
high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
Other Name: HI
Active Comparator: HN-high dose remifentanil with ultra-low dose naloxone
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone).
 Drug: Remifentanil +ultra-low dose naloxone
high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
Other Name: HN


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of Opioid-induced hyperalgesia (OIH) [ Time Frame: 24 hr Post-surgery ]
    Mechanical Pain Threshold-determined by von Frey filaments around the incision site

  2. Occurrence of Opioid-induced hyperalgesia (OIH) [ Time Frame: 48 hr Post-surgery ]
    Mechanical Pain Threshold-determined by von Frey filaments around the incision site


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: 24 hr post surgery ]
    Opioid consumption required to control pain by Oral morphine equivalents

  2. Opioid consumption [ Time Frame: 48 hrs post surgery ]
    Opioid consumption required to control pain by Oral morphine equivalents

  3. Cold Pressure Test [ Time Frame: 24 hr post surgery ]
    Pain Threshold and Pain tolerance

  4. Cold Pressure Test [ Time Frame: 48 hrs post surgery ]
    Pain Threshold and Pain tolerance

  5. Visual Analog Scale (VAS) Pain scores [ Time Frame: Baseline ]
    VAS pain scores measured prior to surgery and at 4, 8 and 12h after extubation and again at 24h and 48h post-operatively

  6. McGill short form questionnaire [ Time Frame: Baseline ]
    The McGill questionnaire provides an assessment of pain quality and descriptors

  7. Brief Pain Inventory [ Time Frame: Baseline ]
    Brief Pain Inventory assesses both pain intensity and pain unpleasantness (the emotional component of pain is considered to be a better metric of subject satisfaction and quality of life).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066739


Contacts
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Contact: Ariana Nelson, MD 714-456-5059 arianamn@hs.uci.edu

Locations
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United States, California
UC Irvine Medical Center Recruiting
Orange, California, United States, 92868
Contact: Michael-David Calderon, BS    714-456-7800 ext 2464    mccalder@uci.edu   
Principal Investigator: Ariana Nelson, MD         
Sponsors and Collaborators
University of California, Irvine
Investigators
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Principal Investigator: Ariana Nelson, MD Assistant Clinical Professor
More Information
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Publications:

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT03066739    
Other Study ID Numbers: UCIANES10 [HS# 2014-1345]
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: May 4, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Remifentanil
Naloxone
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists