Opioid Induced Hyperalgesia (OIH) Modulation With Propranolol

Status Not yet recruiting

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

Hyperalgesia

Clinical Trial Details

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

View Details

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
Completed	`NCT01702389` - Opioid-induced Hyperalgesia After Remifentanil Infusion	Phase 4
Terminated	`NCT01615510` - Evaluation of the Antihyperalgesic Effect of Tapentadol in Two Human Experimental Models	Phase 1
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.