- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07470567
Post-Hoc Cost-Utility Analysis of Ultrasound-Guided Erector Spinae Plane (ESP) Block Versus Total Intravenous Anesthesia (TIVA) in Posterior Scoliosis Correction Surgery: Evidence From the Egyptian EQ-5D-5L Value Set
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
Study Overview
Status
Conditions
Detailed Description
Posterior scoliosis correction surgery is a major orthopedic procedure that involves extensive surgical exposure and is frequently associated with significant postoperative pain. Effective perioperative analgesia is essential to improve patient comfort, facilitate early recovery, and reduce the risk of opioid-related adverse effects.
Ultrasound-guided erector spinae plane (ESP) block is a relatively recent regional anesthesia technique that has shown promising results in improving postoperative analgesia across several surgical procedures. By providing effective thoracic and paraspinal analgesia, ESP block may reduce intraoperative anesthetic requirements and postoperative opioid consumption.
In addition to clinical benefits, evaluating the economic impact of analgesic strategies is increasingly important, particularly in healthcare systems with limited resources. Economic evaluations such as cost-utility analysis allow healthcare decision makers to assess whether new interventions provide sufficient value relative to their costs.
This study aims to evaluate the cost-utility of using ultrasound-guided ESP block with total intravenous anesthesia compared with total intravenous anesthesia (TIVA) alone in patients undergoing posterior scoliosis correction surgery. Health-related quality of life outcomes were assessed using the EQ-5D-5L instrument, and costs were calculated from a healthcare provider perspective during the early postoperative period (8 hours postoperatively )
The findings of this study may provide important evidence regarding the clinical and economic value of ESP block as part of multimodal analgesia strategies in major spine surgery.
((Artificial intelligence-assisted tools were used to generate preliminary drafts of certain descriptive sections. All outputs were critically reviewed, revised, and approved by the study investigators.))
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Katameya Road
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Cairo, Katameya Road, Egypt
- National Bank Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 12-25 years,
- scheduled for posterior spinal fixation for scoliosis correction.
- ASA physical status I-III,
Exclusion Criteria:
- ASA status > III,
- refusal to participate,
- multiple congenital anomalies,
- hypersensitivity or contraindication to study medications,
- and body weight < 40 kg.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
Time Frame: 2 months
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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.
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2 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: basma mohamed, master, National bank hospital ,Cairo, Egypt
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NBH-ANES-PECON-0326-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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