Official Title
Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain: A Multicenter Prospective Study
Brief Title
Phenomics and Genomics of Clinically Relevant Chronic Postsurgical Pain
Protocol ID
NCT04798573
Lead Sponsor
University Health Network, Toronto
Brief Summary
The investigators will approach elective cardiac and thoracic surgery patients in the
preoperative consultation clinic. Consenting individuals will be administered, before
surgery validated pain, psychological and sleep questionnaires. These questionnaires will
be repeated at 3, 6 and 12 months postoperatively (PO) to follow up the progression of
early PO pain and the transition to chronicity. Participants will define clinically
relevant pain by calculating a chronic pain index (CPI). In addition, the investigators
will follow the development of acute postsurgical and chronic pain from before surgery up
to a year after, extract DNA from blood and contrast the genetic variations of
participants with clinically significant chronic pain, to identify variations associated
with the development of chronic post-surgical pain.
Detailed Description
Most patients who undergo surgery heal within weeks to months and return to their
baseline functional status or to an improved level of functioning. However, some patients
have pain after surgery which continues. The purpose of this study is to see if there is
a relationship between patient's genetic makeup (diseases that are passed on in families)
and pain experience following cardiac and thoracic surgeries. This study will look for
links between psychological factors, environmental factors and genetic factors in an
attempt to uncover the risk for developing chronic post-surgical pain.
This study hopes to determine differences between traditional pain surveys and a basic
science approach called "Phenomics" to measure chronic pain response after cardiac and
thoracic surgery. Phenomics or Phenomes is the study of physical characteristics, outside
influences and biochemical changes (traits or chemical characteristics) and their
response to either the environment or genetic changes. Validated pain questionnaires will
be administered before surgery, and will repeated at 3, 6, and 12 months postoperatively
to follow up the progression of early postoperative pain and the transition to
chronicity. In general, the psychological and pain questionnaires are designed to measure
the following: anxiety, thoughts, feelings and reactions toward pain and stressful
experiences.
In addition, the study will follow the development of acute postoperative and chronic
pain from before surgery up to a year after. The investigators will extract DNA from
blood and contrast the genetic variations of participants with clinically significant
chronic pain, to identify variations associated with the development of chronic
post-surgical pain. The blood sample will be drawn at the time of the surgery.
Study Period
Enrollment Count
10,000 participants
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18 years
2. Non- Emergency Cardiac Surgery with Midline Sternotomy OR Thoracic Surgery via VATS
or Lateral Thoracotomy
3. Written informed consent to participate in the study
Exclusion Criteria:
1. Patient unable to understand the study protocol
2. History of a psychotic psychiatric disorder
3. Unable to speak English
Filters
Chronic Pain
Surgery
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT