Clincosm LogoSign in Get a demo

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

Sponsor
Children's Hospital Medical Center, Cincinnati (Other)
Overall Status
Recruiting
CT.gov ID
NCT04681183
Collaborator
(none)
30
Enrollment
1
Location
23.6
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain
    Actual Study Start Date :
    Dec 14, 2020
    Anticipated Primary Completion Date :
    Dec 1, 2022
    Anticipated Study Completion Date :
    Dec 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Chronic post-surgical pain; Unabbreviated scale title "Chronic post-surgical pain scores" [2-6 months after surgery]

      Pain scores over prior 2 weeks reported 2-6 months after surgery; minimum value = 0, maximum value = 10; higher score means more severe pain

    Secondary Outcome Measures

    1. Evoked pressure pain measures; Unabbreviated scale title "Evoked pressure pain measures" [1-2 weeks after surgery]

      Average of 3 measurements taken using a hand-held algometer; minimum value = 0, maximum value = None; higher measurement means better pain tolerance

    2. Resting state connectivity [1 - 8 weeks before surgery]

      Pressure cuff measurements while undergoing MRI scan

    3. Correlation of DNAm of specified gene regions with outcomes [1-8 weeks before surgery or day of surgery]

      Differential DNAm measured by array/sequencing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cincinnati Children's Hospital Cincinnati Ohio United States 45229

    Sponsors and Collaborators

    • Children's Hospital Medical Center, Cincinnati

    Investigators

    • Principal Investigator: Vidya Chidambaran, MD, Children's Hospital Medical Center, Cincinnati

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Hospital Medical Center, Cincinnati
    ClinicalTrials.gov Identifier:
    NCT04681183
    Other Study ID Numbers:
    • 2020-0277
    First Posted:
    Dec 23, 2020
    Last Update Posted:
    Aug 27, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pain, Postoperative

    Study Results

    No Results Posted as of Aug 27, 2021