Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:50 PM
Study NCT ID:
NCT07470567
Status:
COMPLETED
Last Update Posted:
2026-03-16
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012600', 'term': 'Scoliosis'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D013121', 'term': 'Spinal Curvatures'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '2 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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'], 'conditions': ['Scoliosis', 'Spine Deformity']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nThe study aims to determine whether ESP block provides improved patient outcomes and represents a cost-effective strategy for perioperative pain management in scoliosis surgery', 'detailedDescription': '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.\n\nUltrasound-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.\n\nIn 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.\n\nThis 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 )\n\nThe 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.\n\n((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.))'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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 .', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 12-25 years,\n* scheduled for posterior spinal fixation for scoliosis correction.\n* ASA physical status I-III,\n\nExclusion Criteria:\n\n* ASA status \\> III,\n* refusal to participate,\n* multiple congenital anomalies,\n* hypersensitivity or contraindication to study medications,\n* and body weight \\< 40 kg.'}, 'identificationModule': {'nctId': 'NCT07470567', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'National Bank Hospital'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NBH-ANES-PECON-0326-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ESP Block Group Group', 'description': '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.\n\nThe ESP block was performed under ultrasound guidance prior to surgical incision to provide thoracic paraspinal analgesia'}, {'label': 'TIVA Control Group', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Katameya Road', 'country': 'Egypt', 'facility': 'National Bank Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'basma mohamed, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National bank hospital ,Cairo, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Bank Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of health economics unit', 'investigatorFullName': 'Basma Mohamed Elsayed', 'investigatorAffiliation': 'National Bank Hospital'}}}}