Clinical trial: Pilot Study Evaluating Neuro-Imaging Correlates of Epigenetic Finding in Prediction of Chronic Postsurgical Pain (NCT04681183)

Eligibility criteria:
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)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.


Patient description (medical language): A 49-year-old man comes to the office because of the bulging in his groin.  Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases.  His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair.

Patient description (patient's own words): I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair.

Does the patient match the trial criteria? Entailment