Epigenetic Influences on Post-Surgical Acute and Chronic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by The University of Hong Kong
Sponsor:
Information provided by (Responsible Party):
Cheung Chi Wai, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT02002520
First received: November 30, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

Pain is the way our brain interprets certain bodily sensations. It is very difficult to describe or to put into words as perception and tolerance of pain varies widely between individuals. It is known that age, gender and past experience and memory of past experience all contribute to patients' feelings of discomfort and tolerance of pain, but the reason why some patients actually do not experience any pain at all post surgery is still unknown.

Because pain affects every person at some point in their lives, it is of utmost importance that we can find more effective analgesic methods, and provide analgesia tailored to an individual's need as well as discovering new methods which may be able to identify those individuals who are more prone to suffering serious, or chronic pain. It has been proposed that epigenetic modifications may play a role in sensitivity to analgesia and response to trauma, such as post surgery. The effects of epigenetic changes on key genes and the role this plays in analgesia sensitivity and pain perception is deserving of further research.

Epigenetics is a growing field of study in which there are genetic modifications that do not involve changes to base sequences in a gene, but that result nonetheless in changes to gene expression. It has long been known that changes in gene expression play an important role in the establishment of pain states. But it is not known whether a priming injury can induce lasting epigenetic marks which would result in an increase in both postoperative acute pain and the risk for chronic pain. Only by fully understanding these epigenetic mechanisms will we be able to offer better drugs for the treatment of pain, and to identify those at high risk of postoperative pain and postsurgical chronic pain.

The purpose of this study is to determine whether severity of pain following surgical procedures, such as third molar surgery is related to baseline methylation status of the promoter region of IL-6 and TNF-α and changes in methylation status post surgery.


Condition
Acute Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: An Exploratory Study of the Epigenetic Influences on Post-Surgical Acute and Chronic Pain

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • pain score [ Time Frame: From postoperative 1 hour to postoperative 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IL-6 and TNF-α expression [ Time Frame: From postoperative 1 hr to postoperative 3 month ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

RNA and DNA


Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
case group
patients undergo third molar surgery
control group
subjects do not require surgery

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects at Prince Philip Dental Hospital and Queen Mary Hospital

Criteria

Inclusion Criteria:

  • Patient requires third molar surgery for case group and patient does not require surgery for control group
  • Age 18 or above
  • Ability to read and understand the study information and consent form
  • Written consent obtained

Exclusion Criteria:

  • Patient does not requires third molar surgery for case group and patient requires third molar surgery for control group
  • Age below 18
  • Major cognitive or psychiatric disorders that affect the ability to complete study
  • Refuse to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02002520

Contacts
Contact: Chi W Cheung 852 22553303 cheuncw@hku.hk

Locations
Hong Kong
Department of Anaesthesiology, The University of Hong Kong Recruiting
Hong Kong, Hong Kong, 0000
Contact: Yvonne Lee, MPhil    852-22553303    yves@hku.hk   
Department of Anaesthesiology, The University of Hong Kong Not yet recruiting
Hong Kong, Hong Kong, 0000
Contact: Chi W Cheung    852 22553303    cheucw@hku.hk   
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Chi W Cheung Department of Anaesthesiology, The University of Hong Kong
  More Information

No publications provided

Responsible Party: Cheung Chi Wai, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02002520     History of Changes
Other Study ID Numbers: UW13-354
Study First Received: November 30, 2013
Last Updated: January 21, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Acute pain
Epigenetic
Dental pain

Additional relevant MeSH terms:
Chronic Pain
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014