Comprehensive Study of Post-surgical Pain After Pectus or Spine Surgery
Genetic, Epigenetic, Psychosocial, and Biological Determinants of Post-surgical Pain After Pectus or Spine Surgery
1 other identifier
interventional
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 6, 2018
CompletedFirst Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 13, 2025
June 1, 2025
7.5 years
September 20, 2018
June 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Pain score trajectory
Pain scores will be collected preoperatively through 1 year postoperatively
1 year
Changes in self-reported psychosocial scores (including anxiety, pain, coping, physical limitation, etc.)
Psychosocial measures will be collected preoperatively through 1 year postoperatively
1 year
Changes in heart rate variability
Heart rate variability will be assessed preoperatively and postoperatively
8 weeks
Changes in mean amplitude values for lower, upper, and entire alpha frequency bands by group (intervention/no intervention) and time (pre-surgery/post-surgery)
Brain activity will be assessed preoperatively and postoperatively
8 weeks
Changes in evoked response potentials (ERPs) during meditation and experimental pain tasks
Brain activity will be assessed preoperatively and postoperatively
8 weeks
Changes in sleep efficiency/duration (actigraphy) and self-reported sleep quality
Sleep efficiency and quality will be assessed preoperatively and postoperatively
8 weeks
Incidence of side-effect measures
Incidences of respiratory depression, sedation, postoperative nausea and vomiting will be collected during the recovery phase
72 hours postoperatively
Secondary Outcomes (1)
Changes in pressure pain threshold, conditioned pain modulation, tactile discrimination, and temporal summation index
8 weeks
Study Arms (2)
Control
NO INTERVENTIONParticipants in the control group will receive present standard of care, which includes an assessment of participant/family needs by integrative care after surgery, as well as standard holistic health care by a licensed/certified holistic health specialist. They will not receive the MUSETM focused-attention meditation training or intervention protocol.
Meditation
EXPERIMENTALParticipants 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.
Interventions
Participants assigned to the Meditation intervention will receive focused attention meditation training preoperatively, and encouraged to meditate for 20 minutes per day before surgery. In the postoperative inpatient period, the participants will be offered standard holistic health care, reinforcement of meditation training, and encouragement to practice at least 20 minutes of guided focused-attention meditation with breath as their focus, utilizing the MUSETM headband for bio-feedback, every day during their hospital stay. They will be asked to continue using the MUSETM neurofeedback-assisted meditation after hospital discharge, until their visit to repeat pain testing, at which time they will return the MUSETM headband.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (204)
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BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vidya Chidambaran, MD
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2018
First Posted
July 24, 2019
Study Start
July 6, 2018
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
De-identified data may be shared with additional internal or external data warehouses/investigators. These include but are not limited to the i2b2-Research Data Warehouse protocol at CCHMC (IRB 2008-0834) for the purpose of linking this data to de-identified copies of the participants' electronic medical records via an i2b2 database. The resulting de-identified i2b2 database will not be part of this research, and will be used to explore secondary phenotypes in future research studies and the NIH-db-GaP (Database of Genotypes and Phenotypes).