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

Chronic Post-surgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04681183
• Other study ID #: 2020-0277
• Status: Active, not recruiting
• Start date: December 14, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 13
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Post-surgical Pain
• Pain, Postoperative

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evoked pressure pain measures; Unabbreviated scale title "Evoked pressure pain measures"	Average of 3 measurements taken using a hand-held algometer; minimum value = 0, maximum value = None; higher measurement means better pain tolerance	1-2 weeks after surgery
Secondary	Resting state connectivity	Pressure cuff measurements while undergoing MRI scan	1 - 8 weeks before surgery
Secondary	Correlation of DNAm of specified gene regions with outcomes	Differential DNAm measured by array/sequencing	1-8 weeks before surgery or day of surgery