Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02934763
Study type Interventional
Source Pontificia Universidad Catolica de Chile
Contact
Status Not yet recruiting
Phase Phase 4
Start date October 2016
Completion date May 2017

See also
  Status Clinical Trial Phase
Completed NCT01301079 - Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Phase 3
Completed NCT00833755 - Effect of Ketamine on Opioid-Induced Hyperalgesia N/A
Completed NCT00279032 - GW406381 In Patients With Peripheral Nerve Injury Phase 1
Completed NCT03793790 - The Role of Learning in Nocebo Hyperalgesia N/A
Completed NCT03985995 - Pain Response to Cannabidiol in Induced Acute Nociceptive Pain, Allodynia and Hyperalgesia By Using a Model Mimicking Acute Pain in Healthy Adults N/A
Completed NCT04199858 - Electrophysiological Correlates of Nocebo Effects on Pain N/A
Completed NCT02938455 - DNA Methylation and Perioperative Pain Treatment
Completed NCT02653703 - L-menthol as a Topical Counter-irritant to TRPA1-induced Neurogenic Inflammation and Pain N/A
Completed NCT02253966 - Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty Phase 2
Terminated NCT01615510 - Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models Phase 1
Completed NCT01702389 - Opioid-induced Hyperalgesia After Remifentanil Infusion Phase 4
Completed NCT00218374 - Dextromethorphan, Gabapentin, and Oxycodone to Treat Opioid-Induced Hyperalgesia N/A
Completed NCT00387413 - A Study Of GSK189254 And Duloxetine In The Electrical Hyperalgesia Model Of Healthy Volunteers Phase 1
Completed NCT04197154 - Pain-related Fear as a Facilitator of Nocebo Hyperalgesia N/A
Completed NCT02976337 - Effect of High-dose Naloxone Following Third Molar Extraction Phase 2
Completed NCT03354624 - Cortical Neuroplasticity by Muscle Pain of Pain-induced Plasticity N/A
Completed NCT02596360 - Dextromethorphan Effect on Central Sensitization to Pain in Healthy Volunteers Phase 1
Recruiting NCT01480765 - Preventing Pain After Heart Surgery Phase 4
Recruiting NCT01015482 - The Effect of High-dose Remifentanil on Established Sunburn-induced Hyperalgesia in Human Volunteers (HighDose RemiSun) Phase 4
Completed NCT01025245 - Effect of Intraoperative Magnesium on Remifentanil-induced Postoperative Hyperalgesia After Thyroidectomy Phase 4