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

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04031716
Study type	Interventional
Source	Children's Hospital Medical Center, Cincinnati
Contact
Status	Enrolling by invitation
Phase	N/A
Start date	July 6, 2018
Completion date	December 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05480111` - The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy	Phase 4
Completed	`NCT06129305` - Erector Spina Muscle Distance From the Skin at Different Thoracal Elevations
Completed	`NCT04401826` - Micro-surgical Treatment of Gummy Smile	N/A
Recruiting	`NCT04020133` - the Role of Popliteal Plexus Block in Pain Management After Anterior Cruciate Ligament Reconstruction.	N/A
Completed	`NCT03023462` - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair	N/A
Completed	`NCT03546738` - Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery	N/A
Completed	`NCT03652103` - Efficiency of Erector Spinae Plane Block For Patients Undergoing Percutaneous Nephrolithotomy	Phase 4
Terminated	`NCT03261193` - ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain	Phase 3
Withdrawn	`NCT03528343` - Narcotic vs. Non-narcotic Pain Regimens After Pediatric Appendectomy	Phase 1/Phase 2
Completed	`NCT02525133` - Phase 3 Study of Efficacy and Safety of the XaraColl® Bupivacaine Implant After Hernioplasty	Phase 3
Completed	`NCT03244540` - Regional Analgesia After Cesarean Section	Phase 4
Enrolling by invitation	`NCT05316168` - Post Operative Pain Management for ACL Reconstruction	Phase 3
Recruiting	`NCT04130464` - Intraperitoneal Infusion of Analgesic for Postoperative Pain Management	Phase 4
Enrolling by invitation	`NCT04574791` - Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty	N/A
Completed	`NCT04073069` - Scalp Infiltration With Diprospan Plus Ropivacaine for Postoperative Pain After Craniotomy in Adults	Phase 4
Completed	`NCT04526236` - Influence of Aging on Perioperative Methadone Dosing	Phase 4
Recruiting	`NCT05351229` - Intrathecal Morphine for Analgesia in Video-assisted Thoracic Surgery	Phase 4
Enrolling by invitation	`NCT05543109` - Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block	N/A
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Completed	`NCT04919317` - Combination Dexamethasone and Bupivacaine Pain Control in Reduction Mammaplasty	Phase 2