NCT04038229

Brief Summary

Posterior Spinal fusion (PSF) is one of the most invasive orthopedic surgical procedures in children and adolescents, often characterized by extensive tissue trauma, and severe postoperative pain. In addition to pain, the postoperative period is complicated by the side effects of opioids such as nausea and vomiting, itching and sedation. Various studies have shown that pain in the direct postoperative phase is an important determinant for development of chronic post-surgical pain. The consequences of untreated acute pain are known and can also contribute to chronification in pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

December 9, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 15, 2023

Status Verified

May 1, 2023

Enrollment Period

1.9 years

First QC Date

July 26, 2019

Last Update Submit

May 12, 2023

Conditions

AnalgesiaScoliosis IdiopathicSurgeryPostoperative Pain

Keywords

enhanced recovery pathwayanalgesiatele-monitoringbiopsychosocial evaluation

Outcome Measures

Primary Outcomes (1)

  • postoperative pain

    Evaluation of pain at rest and during mobilization using 11 point numeric rating scale daily during hospital admission and is continued after discharge up to 3 months postoperatively

    From admission postoperative anesthesia care unit (PACU) up to 3 months postoperatively

Secondary Outcomes (4)

  • evaluation of opioid-related side effect

    From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

  • sleep

    From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

  • daily activity

    From admission postoperative anesthesia care unit (PACU) up to 3 months after surgery

  • mobility

    From day of surgery until hospital discharge (approximately 7 days)

Other Outcomes (5)

  • State-Trait anxiety Inventory (STAI)

    3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

  • Multidimensional Pain Inventory (MPI, Part 1)

    3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

  • Child and Adolescent Social and Adaptive Scale (CASAFS)

    3 times: one to two weeks before planned surgery, 4 weeks after surgery and at 12 weeks after surgery

  • +2 more other outcomes

Study Arms (2)

Standard of care

NO INTERVENTION

Prospective derived data from children and adolescents undergoing spinal fusion due to idiopathic scoliosis

Enhanced recovery pathway

EXPERIMENTAL

Children and adolescents undergoing spinal fusion due to idiopathic scoliosis using the pre -per and postoperative enhanced recovery protocol

Other: Enhanced recovery pathway

Interventions

Enhanced recovery pathwayOTHER

The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term

Enhanced recovery pathway

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • approved written informed consent by parent or legal representative
  • idiopathic adolescent scoliosis
  • planned for elective surgery: posterior spinal fusion

You may not qualify if:

  • other types of scoliosis
  • chronic opioid usage (more than 3 months)
  • known unstable psychiatric medical condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Study Officials

  • Guy Hans, MD, PhD

    University Hospital, Antwerp

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

July 26, 2019

First Posted

July 30, 2019

Study Start

December 9, 2019

Primary Completion

November 3, 2021

Study Completion

January 1, 2022

Last Updated

May 15, 2023

Record last verified: 2023-05

Locations

BE(1)