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Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol

Sponsor
Pontificia Universidad Catolica de Chile (Other)
Overall Status
Unknown status
CT.gov ID
NCT02934763
Collaborator
(none)
80
Enrollment
3
Arms
7
Duration (Months)

Study Details

Study Description

Brief Summary

Opioid Induced Hyperalgesia (OIH) is an entity than has been demonstrated in healthy volunteers and in animal models. Is defined as an increase in the perception to painful stimuli, increasing the opioid requirements and diminishing the pain thresholds to stimuli.

The apparition of OIH is also related to the exposure to opioids during surgery, depending of the dose, the time of exposition and the type of opioid.

This condition can be modulated, specially in the perioperative context. It has been seen in healthy volunteers and in animal models, than the use of propranolol can modulate this phenomena, diminishing the postoperative requirements of analgesia. It is also unknown, the dose of propranolol required to modulate adequately OIH.

The objective of this work is to evaluate the efficacy of propranolol in the modulation of opioid induced hyperalgesia, with lower postoperative requirements of analgesia rescue.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

This is a randomized controlled study, comparing 2 interventions with a placebo. The interventions will be use of propranolol, at different doses, to achieve specific plasmatic concentrations.

80 patients will be required to find a difference of 20% in the primary outcome.

The primary outcome to be measured is the postoperative use of opioids in the post anesthesic care unit.

Secondary outcomes, will be the amount of opioids used in the following 24 hours to the surgery, the time to the first dose of analgesia in the post anesthesic care unit, and the change in the pain thresholds, evaluated as pain by pressure and by tactile sensitivity, before and after surgery.

Also, as a secondary outcome, in a group than will not receive the study drug, we will evaluate the temporal changes in opioid induced hyperalgesia, by pain sensitivity measured in the postoperative hours 2, 4 and 24. 10 patients receiving placebo will be part of this additional measures.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol, in Laparoscopic Abdominal Surgery
Study Start Date :
Oct 1, 2016
Anticipated Primary Completion Date :
Apr 1, 2017
Anticipated Study Completion Date :
May 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Saline solution by target controlled infusion

Drug: Saline
Saline as placebo
Other Names:
  • Placebo

    		•
    Active Comparator: Propranolol at 5ng/ml target dose

    Propranolol iv by target controlled infusion, to achieve a plasmatic concentration of 5ng/ml

    Drug: Propranolol
    propranolol iv by target controlled infusion, to achieve specific plasmatic concentration goals
    Other Names:
  • Beta blocker

    		•
    Active Comparator: Propranolol at 15ng/ml target dose

    Propranolol iv by target controlled infusion, to achieve a plasmatic concentration of 15ng/ml

    Drug: Propranolol
    propranolol iv by target controlled infusion, to achieve specific plasmatic concentration goals
    Other Names:
  • Beta blocker

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative opioid use [24 hours posterior to surgery]

      Dose of opioid required to manage pain adequately

    Secondary Outcome Measures

    1. Pain thresholds (heat) [24 hours posterior to surgery]

      Evaluation of the threshold to perceive a heat perception as pain

    2. Pain thresholds (cold) [24 hours posterior to surgery]

      Evaluation of the threshold to perceive a cold perception as pain

    3. Pain thresholds (tactile sensitivity) [24 hours posterior to surgery]

      Evaluation of pain by tactile sensitivity, using the PinPrick system

    4. Temporal changes in pain sensibility [24 hours posterior to surgery]

      Evaluation of pain by tactile sensitivity, using the PinPrick system

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients scheduled for elective laparoscopic cholecystectomy

    • American Society of Anesthesiology Score (ASA) I-II

    Exclusion Criteria:

    • Medical history of cardiac disease

    • Medical history of respiratory disease

    • Regular use of beta blockers

    • Known allergies to drugs used in the study

    • Known history of illicit drugs use

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pontificia Universidad Catolica de Chile

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Pontificia Universidad Catolica de Chile
    ClinicalTrials.gov Identifier:
    NCT02934763
    Other Study ID Numbers:
    • 16-145
    First Posted:
    Oct 17, 2016
    Last Update Posted:
    Oct 27, 2016
    Last Verified:
    Oct 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:
    Hyperalgesia
    Propranolol

    Study Results

    No Results Posted as of Oct 27, 2016