NCT07470567

Brief Summary

Posterior scoliosis correction surgery is associated with sever postoperative pain that necessitate high perioperative opioid doses to alleviate pain . Regional anesthesia techniques such as ultrasound-guided erector spinae plane (ESP) block have emerged as promising strategies for improving postoperative analgesia and reducing opioid consumption. This secondary analysis evaluates the cost-utility of ESP block compared with total intravenous anesthesia (TIVA) alone in patients scheduled for posterior scoliosis correction surgery. The analysis assesses postoperative quality of life using the EQ-5D-5L instrument value sets from Egyptian population alongside healthcare costs within the early postoperative period. The study aims to determine whether ESP block provides improved patient outcomes and represents a cost-effective strategy for perioperative pain management in scoliosis surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2025

Shorter than P25 for all trials

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

Study Start

First participant enrolled

October 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 10, 2026

Last Update Submit

March 12, 2026

Conditions

Keywords

erector spinae plan block ,regional anesthesia ,postoperative pain ,cost utility analysis , EQ-5D-5Lerector spinae plan blockanesthesiapostoperative paincost utility analysis

Outcome Measures

Primary Outcomes (1)

  • economic evaluation (cost utility analysis )of anesthesia (ESP block) compared with (TIVA) alone and the resulting consumption of health resources in patients scheduled for scoliosis correction from a healthcare payer pers

    To implement an economic evaluation (cost utility analysis) in addition to the evaluation of clinical effects in order to make rational decisions regarding the acceptance of new mode of anesthesia (ESP block) compared with total intravenous anesthesia (TIVA) alone and the resulting consumption of health resources in patients scheduled for scoliosis correction from a healthcare payer perspective.

    2 months

Study Arms (2)

ESP Block Group Group

Patients undergoing posterior scoliosis correction surgery who received ultrasound-guided erector spinae plane (ESP) block in addition to total intravenous anesthesia (TIVA) as part of multimodal perioperative analgesia. The ESP block was performed under ultrasound guidance prior to surgical incision to provide thoracic paraspinal analgesia

TIVA Control Group

Patients undergoing posterior scoliosis correction surgery who received total intravenous anesthesia (TIVA) without erector spinae plane block. Standard perioperative analgesia and anesthetic management were provided according to institutional protocol

Eligibility Criteria

Age12 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients aged 12-25 years diagnosed with scoliosis and scheduled for posterior spinal fixation surgery were included in the study. All participants were classified as ASA physical status I-III and underwent surgery under general anesthesia in the operating rooms .

You may qualify if:

  • Patients aged 12-25 years,
  • scheduled for posterior spinal fixation for scoliosis correction.
  • ASA physical status I-III,

You may not qualify if:

  • ASA status \> III,
  • refusal to participate,
  • multiple congenital anomalies,
  • hypersensitivity or contraindication to study medications,
  • and body weight \< 40 kg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Bank Hospital

Cairo, Katameya Road, Egypt

Location

MeSH Terms

Conditions

ScoliosisPain, Postoperative

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • basma mohamed, master

    National bank hospital ,Cairo, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of health economics unit

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

October 15, 2025

Primary Completion

January 15, 2026

Study Completion

February 28, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

individual participant data (IPD) will not be publicly available. Data will be stored securely at the study institution and may be made available upon reasonable request and with institutional approval.

Locations