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DNA Methylation and Perioperative Pain Treatment (MEDAPO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02938455
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : September 4, 2019
Information provided by (Responsible Party):
Andrea Fanelli, University of Bologna

Brief Summary:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Primary Outcome Measures :
  1. DNA Methylation [ Time Frame: 2 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient undergoing elective major surgery under general anesthesia

Inclusio Criteria: patients schedule for major surgery (longer than 120 minutes) exposed to opioid in the perioperative period; patients opioid naive prior to surgery; ASA < 4; 17 < BMI < 36.

Exclusion Criteria: renal and hepatic failure; OSAS; Apfel score > 3.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02938455

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Contact: Andrea Fanelli, MD 00393441285388
Contact: Rita Maria Melotti, Professor 00393355934325

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Andrea Fanelli Recruiting
Bologna, Italy, 40138
Contact: Andrea Fanelli, MD   
Contact: Rita Maria Melotti, Professor   
Sponsors and Collaborators
University of Bologna
Additional Information:

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Responsible Party: Andrea Fanelli, MD, University of Bologna Identifier: NCT02938455    
Other Study ID Numbers: MEDAPO
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Andrea Fanelli, University of Bologna:
Postoperative pain
DNA methylation
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Somatosensory Disorders
Sensation Disorders
Nervous System Diseases