Clinical trial NCT04031716: Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Official title: Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Excavatum, Pectus
Scoliosis Idiopathic
Keywords: Meditation
Pectus Excavatum
Scoliosis
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 600
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive standard perioperative care, anesthetic management, and postoperative pain management per institutional standardized practices. Participants will be randomized into either the Meditation or Control Groups, as deemed appropriate.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a prospective study to determine the association between specific genotypes, epigenetics, behavioral, social and biological factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic effects, side effects to perioperative analgesics, chronic postoperative pain, and gene expression in patients following pectus excavatum repair.

Detailed description: This study will be a clinical prospective study. It is observational for all aims except with regard to the Meditation Intervention, which will be limited to 100 pectus and 100 spine participants (randomized to 50/50 in each arm). We will recruit 600 qualifying participants over the study period to acquire the necessary data to derive a predictive model matching phenotype to genotype. This study will not interfere with the standard anesthetic or perioperative care except for blood sampling from an indwelling line, and the use of additional integrative health procedures (focused-attention meditation guidance, as well as routine massage and breathing techniques) for the randomized meditation group. Research staff will administer psychosocial and somatosensory assessments, as well as record relevant data from participant's medical records. Integrative health will assist in teaching focused-attention meditation to the randomized meditation participants in the preoperative phase. Actigraphy devices will be provided to all participants, and MUSETM to those in the randomized meditation group. The pain team, in accordance with the Pectus Pain Management Protocol, will direct perioperative pain management.

Eligibility criteria: Inclusion Criteria:

* Children aged 8 years of age through adulthood
* Diagnosis of pectus excavatum or adolescent idiopathic scoliosis
* Scheduled for endoscopic pectus excavatum repair or spine fusion

Exclusion Criteria:

* History of or active renal or liver disease
* Major surgery requiring opioids in the last 5 years
* Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month)
* Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included
* History of seizures currently treated on medication (participants off medication and seizure free for greater than one year may be included)
* Taking no more than two concomitant medications known to induce or inhibit CYP2D6 activity, including paroxetine, fluoxetine, cimetidine, and duloxetine
* Needing postoperative ventilation or intraoperative cardiac bypass standby
* BMI \>35
* Pregnant or breastfeeding females
* Non-English speaking
* Definite developmental delay

Primary outcomes:
measure: Pain score trajectory
timeFrame: 1 year
measure: Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.)
timeFrame: 1 year
measure: Changes in heart rate variability
timeFrame: 8 weeks
measure: Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery)
timeFrame: 8 weeks
measure: Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks
timeFrame: 8 weeks
measure: Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality
timeFrame: 8 weeks
measure: Incidence of side-effect measures
timeFrame: 72 hours postoperatively
Secondary outcomes:
measure: Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Vidya Chidambaran, MD
role: PRINCIPAL_INVESTIGATOR
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