Chronic Pain After Scoliosis and Thoracic Surgery in Children

Completed

• Conditions: Scoliosis; Adolescence; Chronic Pain; Thoracic Surgery; Pediatric ALL

• Registration Number: NCT02995525
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated \> 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years.

The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years.

The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-10
• Status Verified: 2016-12
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-13
• Study First Posted: 2016-12-16
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• children aged from 6 to 18 years undergoing scoliosis or thoracic surgery in paediatric Bordeaux hospital.

Exclusion Criteria

• patients who not willing to participate, with children and/or parental insufficient understanding of the questionnaires.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
pain at 4 months after surgery	4 months after scoliosis and thoracic surgery in children aged 6 to 18 years	visual analogue scale for pain (0_100)

Secondary Outcome Measures

Name	Time	Method
adverse events after surgery	adverse events during peri-operative period (hospital stay, i.e. during the first month after surgery)	infections, neurologic defect, new surgery, blood hematoma
prevalence of neuropathic syndrome during perioperative period and at 4 months after surgery	2'4-48 h hours period after surgery, 4 months after surgery	DN4 questionnaire
morphine consumption during the perioperative period	the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)	morphine consumption (mg/day)
pain at 4 months after surgery	4 months after scoliosis and thoracic surgery in disabled children aged 6 to 18 years	modified FLACC scale for pain
pain during the perioperative period	the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)	visual analogue scale for pain (0-100)
pain during the perioperative period in disabled children aged 6 to 18 years	the perioperative period (preoperative period i.e. more than 1 month before, the month before, the before surgery; during hospitalization)	FLACC scale level (0-100)

Trial Locations

Locations (1)

Centre hospitalier Universitaire de Bordeaux; 🇫🇷 Bordeaux, France