DNA Methylation and Perioperative Pain Treatment (MEDAPO)
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|ClinicalTrials.gov Identifier: NCT02938455|
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : September 4, 2019
In the last few years much attention has been paid to hyperalgesia induced by opioids, which represents a clinically significant condition following acute and chronic exposure to opioids. It has been suggested that the increase in gene expression of μ-opioid receptors and the development of hyperalgesia could be linked to epigenetic mechanisms. In particular the use of opioids seems to be related to an increase of the degree of DNA methylation. In the literature are not currently available data about the degree of DNA methylation in surgical patients, opioid-naive prior to surgery, receiving acute opioids treatment in the perioperative period.
The primary objective of this study is to assess the degree of perioperative DNA methylation (extracted from whole blood) in patients undergoing major surgery exposed to opioids according to current clinical practice compared to preoperative baseline levels. The timing (preoperative vs intraoperative vs postoperative) in which the possible increase of the degree of DNA methylation will happen wil be assessed.
20 consecutive patients undergoing major surgery performed under general anesthesia that have expressed their consent to participate to the study will be enrolled. This sample is adequate to allow the observation of a possible increase of DNA methylation in opioid-naive patients exposed to anesthesia/analgesia based on opiates according to current clinical practice.
|Condition or disease|
|Hyperalgesia Pain, Postoperative|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||20 participants|
|Target Follow-Up Duration:||2 Days|
|Official Title:||Explorative Study About the Degree of DNA Methylation Related to Acute Perioperative Pain Treatment|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
- DNA Methylation [ Time Frame: 2 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938455
|Contact: Andrea Fanelli, MDemail@example.com|
|Contact: Rita Maria Melotti, Professorfirstname.lastname@example.org|