Status:
ACTIVE_NOT_RECRUITING
Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Chronic Post-surgical Pain
Eligibility:
All Genders
8+ years
Brief Summary
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...
Detailed Description
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 me...
Eligibility Criteria
Inclusion
- 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
- 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
- Claustrophobia
- Metallic implants/orthodontics/braces or other MRI exclusion (MRI safety screening will be conducted prior to enrollment and prior to each MRI scan)
Key Trial Info
Start Date :
December 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04681183
Start Date
December 14 2020
End Date
December 1 2024
Last Update
March 13 2024
Active Locations (1)
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1
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229