Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain

  • days left to enroll
  • participants needed
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 2 September 2021


This pilot research study is being performed to learn more about pain and look at how pain changes brain chemistry and function. The research team would like to learn new information to better control chronic pain after surgery. This information collected in this research will be used to plan possible future visits. Participants in this study are being asked to participate because they are scheduled for an upcoming surgery. The research team would like to observe them before and after their surgery.


This study is a pilot feasibility study in 30 healthy, preoperative children and young adults undergoing major surgery with high risk for chronic post-surgical pain (CPSP) to characterize the brain metabolite status of the Anterior cingulate cortices (ACC) and insula in pre-surgical adolescents and to understand the relationship between metabolite levels and CPSP. The investigators will also examine whether neurochemical tone in these regions is related to resting state functional connectivity with other brain regions. Correlations between differentially methylated CpG sites in genes enriching gamma aminobutyric acid (GABA) and Dopamine-DARPP-32 pathways and Glu/GABA levels in insula/ACC will be analyzed.

Condition Chronic Post-surgical Pain
Clinical Study IdentifierNCT04681183
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on2 September 2021


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Inclusion Criteria

Male or female aged 8 yrs of age
English speaking
Healthy (Defined as American Society of Anesthesiologists Physical Status 1 or 2)
Ability to provide assent/consent/parent permission
Scheduled to undergo chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement

Exclusion Criteria

History of chronic pain conditions including migraines
Use of opioids chronically or for major surgery within the 6 months prior to enrollment
Severe obesity (BMI>35 kg/m2)
Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine or other medications used to treat attention deficit hyperactivity disorder (medications containing amphetamine or methylphenidate)
Use of hormonal contraceptives
Use of medications that may alter pain sensitivity (e.g. gabapentin,/pregabalin amitryptiline/other antidepressants, clonidine)
Active or history of renal/liver problems or congenital cardiac disease
Diagnosed developmental delay
Pregnant or lactating females
Any skin condition that prevents cuff application
History of seizures
Metallic implants/orthodontics/braces or other MRI exclusion (MRI safety screening will be conducted prior to enrollment and prior to each MRI scan)
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