ScoliosisNCT07470567
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
An observational study of Scoliosis and Spine Deformity, run by National Bank Hospital at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Scoliosis, Spine Deformity
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2025to 28 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
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 .
Who may be able to join
- Patients aged 12-25 years,
- scheduled for posterior spinal fixation for scoliosis correction.
- ASA physical status I-III,
Who cannot join
- ASA status > III,
- refusal to participate,
- multiple congenital anomalies,
- hypersensitivity or contraindication to study medications,
- and body weight < 40 kg.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.))
- Conditions
- Scoliosis, Spine Deformity
- Keywords
- erector spinae plan block ,regional anesthesia ,postoperative pain ,cost utility analysis , EQ-5D-5L, erector spinae plan block, anesthesia, postoperative pain, cost utility analysis
- Medical subject headings
- Scoliosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Oct 2025
- Primary completion15 Jan 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Bank Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basma Mohamed Elsayed, National Bank Hospital
- Investigators
- basma mohamed, master, Principal investigator, National bank hospital ,Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470567
- Sponsor's protocol ID
- NBH-ANES-PECON-0326-01
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07470567
- Acronym / sponsor ID
- NBH-ANES-PECON-0326-01
- Conditions
- Scoliosis, Spine Deformity
- Keywords
- erector spinae plan block ,regional anesthesia ,postoperative pain ,cost utility analysis , EQ-5D-5L, erector spinae plan block, anesthesia, postoperative pain, cost utility analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- National Bank HospitalUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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 .
Key inclusion criteria (3 listed)
- Patients aged 12-25 years,
- scheduled for posterior spinal fixation for scoliosis correction.
- ASA physical status I-III,
Key exclusion criteria (5 listed)
- ASA status > III,
- refusal to participate,
- multiple congenital anomalies,
- hypersensitivity or contraindication to study medications,
- and body weight < 40 kg.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
basma mohamed, master principal investigator
National bank hospital ,Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Spine Deformity, run by National Bank Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.