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

NCT04681183 | Active Not Recruiting

• 1 other identifier: 2020-0277
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Post-surgical Pain

Outcome Measures

Primary Outcomes (1)

• Chronic post-surgical pain; Unabbreviated scale title "Chronic post-surgical pain scores"

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

  2-6 months after surgery

Secondary Outcomes (3)

• Evoked pressure pain measures; Unabbreviated scale title "Evoked pressure pain measures"

  1-2 weeks after surgery

• Resting state connectivity

  1 - 8 weeks before surgery

• Correlation of DNAm of specified gene regions with outcomes

  1-8 weeks before surgery or day of surgery

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing chest surgery (thoracotomy, thoracoscopy, Nuss procedure, pectus surgery, mastectomy), spine surgery, amputation, hernia repair or hip/knee replacement in the hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital

Cincinnati, Ohio, 45229, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be isolated from blood samples and be used for pyrosequencing studies to obtain DNA methylation information for a specified set of genes or use of the Methylation EPIC array. DNA samples gathered will be held for future analysis.

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Vidya Chidambaran, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 23, 2020
• Study Start: December 14, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

US (1)