Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02934763
Recruitment Status : Unknown
Verified October 2016 by Pontificia Universidad Catolica de Chile.
Recruitment status was:  Not yet recruiting
First Posted : October 17, 2016
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

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
Hyperalgesia Drug: Propranolol Drug: Saline 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2016
Estimated Primary Completion Date : April 2017
Estimated Study Completion Date : May 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Saline solution by target controlled infusion
Drug: Saline
Saline as placebo
Other Name: 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 Name: 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 Name: Beta blocker




Primary Outcome Measures :
  1. Postoperative opioid use [ Time Frame: 24 hours posterior to surgery ]
    Dose of opioid required to manage pain adequately


Secondary Outcome Measures :
  1. Pain thresholds (heat) [ Time Frame: 24 hours posterior to surgery ]
    Evaluation of the threshold to perceive a heat perception as pain

  2. Pain thresholds (cold) [ Time Frame: 24 hours posterior to surgery ]
    Evaluation of the threshold to perceive a cold perception as pain

  3. Pain thresholds (tactile sensitivity) [ Time Frame: 24 hours posterior to surgery ]
    Evaluation of pain by tactile sensitivity, using the PinPrick system

  4. Temporal changes in pain sensibility [ Time Frame: 24 hours posterior to surgery ]
    Evaluation of pain by tactile sensitivity, using the PinPrick system



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Layout table for additonal information
Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT02934763     History of Changes
Other Study ID Numbers: 16-145
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
Layout table for MeSH terms
Propranolol
Hyperalgesia
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents