A Phase 4 interventional study of Propranolol and Saline in Hyperalgesia, sponsored by Pontificia Universidad Catolica de Chile. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-10-27.
Sponsored by Pontificia Universidad Catolica de Chile · Phase 4, Interventional, and Treatment
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.
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.
152 studies on the registry are indexed under Hyperalgesia; 13 are open to participants now.
This study's planned enrollment of 80 is above the median of 42 across 127 interventional studies indexed under Hyperalgesia.
Browse Hyperalgesia studies →Pontificia Universidad Catolica de Chile is the lead sponsor of 215 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Saline solution by target controlled infusion
Drug: Saline
Propranolol iv by target controlled infusion, to achieve a plasmatic concentration of 5ng/ml
Drug: Propranolol
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
Also known as: Beta blocker
Saline as placebo
Also known as: Placebo
Postoperative opioid use
Dose of opioid required to manage pain adequately
Time frame: 24 hours posterior to surgery
Pain thresholds (heat)
Evaluation of the threshold to perceive a heat perception as pain
Time frame: 24 hours posterior to surgery
Pain thresholds (cold)
Evaluation of the threshold to perceive a cold perception as pain
Time frame: 24 hours posterior to surgery
Pain thresholds (tactile sensitivity)
Evaluation of pain by tactile sensitivity, using the PinPrick system
Time frame: 24 hours posterior to surgery
Temporal changes in pain sensibility
Evaluation of pain by tactile sensitivity, using the PinPrick system
Time frame: 24 hours posterior to surgery
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pontificia Universidad Catolica de Chile