Hyperalgesia Clinical Trial
Official title:
Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol, in Laparoscopic Abdominal Surgery
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.
Status | Not yet recruiting |
Enrollment | 80 |
Est. completion date | May 2017 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Postoperative opioid use | Dose of opioid required to manage pain adequately | 24 hours posterior to surgery | No |
Secondary | Pain thresholds (heat) | Evaluation of the threshold to perceive a heat perception as pain | 24 hours posterior to surgery | No |
Secondary | Pain thresholds (cold) | Evaluation of the threshold to perceive a cold perception as pain | 24 hours posterior to surgery | No |
Secondary | Pain thresholds (tactile sensitivity) | Evaluation of pain by tactile sensitivity, using the PinPrick system | 24 hours posterior to surgery | No |
Secondary | Temporal changes in pain sensibility | Evaluation of pain by tactile sensitivity, using the PinPrick system | 24 hours posterior to surgery | No |
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