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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04681183
Enrollment
13
Registered
2020-12-23
Start date
2020-12-14
Completion date
2024-12-01
Last updated
2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Post-surgical Pain

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 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.

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 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.

Interventions

None listed

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male or female aged ≥ 8 yrs of age 2. English speaking; 3. Healthy (Defined as American Society of Anesthesiologists Physical Status 1 or 2) 4. Ability to provide assent/consent/parent permission. 5. Scheduled to undergo chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement.

Exclusion criteria

1. History of chronic pain conditions including migraines 2. Use of opioids chronically or for major surgery within the 6 months prior to enrollment 3. Severe obesity (BMI\>35 kg/m2) 4. 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). 5. Use of hormonal contraceptives 6. Use of medications that may alter pain sensitivity (e.g. gabapentin,/pregabalin amitryptiline/other antidepressants, clonidine). 7. Active or history of renal/liver problems or congenital cardiac disease 8. Diagnosed developmental delay 9. Pregnant or lactating females 10. Any skin condition that prevents cuff application 11. History of seizures 12. Claustrophobia 13. Metallic implants/orthodontics/braces or other MRI exclusion (MRI safety screening will be conducted prior to enrollment and prior to each MRI scan)

Design outcomes

Primary

MeasureTime frameDescription
Chronic post-surgical pain; Unabbreviated scale title Chronic post-surgical pain scores2-6 months after surgeryPain scores over prior 2 weeks reported 2-6 months after surgery; minimum value = 0, maximum value = 10; higher score means more severe pain

Secondary

MeasureTime frameDescription
Evoked pressure pain measures; Unabbreviated scale title Evoked pressure pain measures1-2 weeks after surgeryAverage of 3 measurements taken using a hand-held algometer; minimum value = 0, maximum value = None; higher measurement means better pain tolerance
Resting state connectivity1 - 8 weeks before surgeryPressure cuff measurements while undergoing MRI scan
Correlation of DNAm of specified gene regions with outcomes1-8 weeks before surgery or day of surgeryDifferential DNAm measured by array/sequencing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026