NCT06194279

Brief Summary

Idiopathic scoliosis surgery is a major surgery, causing significant post-operative pain which can have a significant impact, both for the patient and for society. Different analgesic strategies have emerged in recent years, within the framework of multimodal analgesia including systemic analgesics, but also axial or peripheral loco-regional anesthesia (LRA). These techniques are integrated into the recommendations of learned societies, aimed at optimizing the post-operative rehabilitation of patients. If intrathecal morphine injection (ITM) and spinal erector block (ESPB) have already shown their effectiveness in reducing postoperative pain, the combination of these techniques can have a real benefit in major spinal surgery. , and has not yet been studied.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 19, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 8, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

January 8, 2024

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

December 15, 2023

Last Update Submit

January 5, 2024

Conditions

Keywords

Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

  • Morphine dose administered 24 hours post-operative

    The aim of this retrospective study is to compare the different analgesic strategies postoperatively after scoliosis surgery

    24 hours post-operative

Eligibility Criteria

Age16 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged \> 15 years who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023

You may qualify if:

  • Patient aged \> 15 years
  • Patient who underwent scoliosis surgery by the spine surgery team at Hautepierre hospital between January 1, 2020 and June 30, 2023
  • Patient or holder of parental authority not opposing the reuse of their data for scientific research purposes

You may not qualify if:

  • Oral or written refusal of the patient (or the holder of parental authority) to reuse their data for scientific research purposes
  • History of spinal surgery
  • Level 3 analgesics at home
  • Protection of justice, titular or curatorship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie Réanimation Médecine Péri Opératoire - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 15, 2023

First Posted

January 8, 2024

Study Start

June 19, 2023

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

January 8, 2024

Record last verified: 2023-12

Locations