Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery

Not Applicable

• Conditions: Pain, Postoperative; Excavatum, Pectus; Scoliosis Idiopathic
• Interventions: Behavioral: Meditation

• Registration Number: NCT04031716
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Study Timeline

• Study Start: 2018-07-06
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2019-07-23
• Study First Posted: 2019-07-24
• Status Verified: 2024-01
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Meditation	Meditation	Participants randomized to receive focused-attention meditation training will attend a preoperative training session, provided by a licensed/certified Holistic Health Specialist. The content will include an age appropriate explanation of focused-attention meditation, using breath as the focus; set-up and utilization of the MUSETM headband; and experiential practices. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions, and thoughts), provide self-regulation strategies, and promote healthy and adaptive responses to stress.

Primary Outcome Measures

Name	Time	Method
Pain score trajectory	1 year	Pain scores will be collected preoperatively through 1 year postoperatively
Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.)	1 year	Psychosocial measures will be collected preoperatively through 1 year postoperatively
Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks	8 weeks	Brain activity will be assessed preoperatively and postoperatively
Changes in heart rate variability	8 weeks	Heart rate variability will be assessed preoperatively and postoperatively
Incidence of side-effect measures	72 hours postoperatively	Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase
Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery)	8 weeks	Brain activity will be assessed preoperatively and postoperatively
Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality	8 weeks	Sleep efficiency and quality will be assessed preoperatively and postoperatively

Secondary Outcome Measures

Name	Time	Method
Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index	8 weeks	Quantitative sensory testing will be assessed preoperatively and postoperatively

Trial Locations

Locations (1)

Cincinnati Childrens Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States