Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:40 AM
Study NCT ID:
NCT07454304
Status:
COMPLETED
Last Update Posted:
2026-03-10
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided vs. Surgeon-Performed (Free-hand) Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007405', 'term': 'Intervertebral Disc Displacement'}, {'id': 'C535531', 'term': 'Intervertebral disc disease'}], 'ancestors': [{'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes Assessor and participant were blinded to the study'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, randomized, single-blind, parallel-group clinical trial. Patients undergoing elective Unilateral Biportal Endoscopic Discectomy (UBE) were randomized in a 1:1 ratio into two groups using a computer-generated randomization schedule. The study model aims to compare the clinical equivalence or superiority of a surgeon-performed (free-hand) ESPB technique against the conventional ultrasound-guided (USG) ESPB performed by an anesthesiologist. Both groups received a standardized volume and concentration of local anesthetic (30 ml of 0.25% bupivacaine) to ensure comparability of the analgesic effect'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-12-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Score (NRS) at 6th hour.', 'timeFrame': '6 hours after surgery.', 'description': 'Pain intensity measured by NRS (0-10, where 0=no pain, 10=worst pain).'}], 'secondaryOutcomes': [{'measure': 'Postoperative Pain Score / NRS at other intervals', 'timeFrame': 'Changes from baseline pain scores at postoperative 1, 2, 12, and 24 hours', 'description': 'NRS scores at 1, 2, 12, and 24 hours postoperatively. (0-10, where 0=no pain, 10=worst pain).'}, {'measure': 'Rescue Analgesic Consumption', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Total amount of Tramadol used within the first 24 hours (mg).'}, {'measure': 'Opioid-related Side Effects', 'timeFrame': 'Postoperative 24 hours period', 'description': 'Presence of nausea, vomiting, or pruritus (Yes/No) within 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Unilateral Biportal Endoscopic Discectomy', 'Postoperative analgesia management', 'Erector Spinae Plane Block'], 'conditions': ['Lumbar Disc Herniation', 'Lumbar Disc Disease']}, 'referencesModule': {'references': [{'pmid': '38170270', 'type': 'BACKGROUND', 'citation': 'Mirkheshti A, Raji P, Komlakh K, Salimi S, Shakeri A. The efficacy of ultrasound-guided erector spinae plane block (ESPB) versus freehand ESPB in postoperative pain management after lumbar spinal fusion surgery: a randomized, non-inferiority trial. Eur Spine J. 2024 Mar;33(3):1081-1088. doi: 10.1007/s00586-023-08101-9. Epub 2024 Jan 3.'}, {'pmid': '38834814', 'type': 'BACKGROUND', 'citation': 'Kaciroglu A, Ekinci M, Gurbuz H, Ulusoy E, Ekici MA, Dogan O, Golboyu BE, Alver S, Ciftci B. Surgical vs ultrasound-guided lumbar erector spinae plane block for pain management following lumbar spinal fusion surgery. Eur Spine J. 2024 Jul;33(7):2630-2636. doi: 10.1007/s00586-024-08347-x. Epub 2024 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the analgesic efficacy of ultrasound-guided (USG) lumbar Erector Spinae Plane Block (ESPB) performed by an anesthesiologist versus a "free-hand" ESPB performed intraoperatively by the surgeon in patients undergoing Unilateral Biportal Endoscopic Discectomy (UBE). The investigators hypothesize that Us-guided would provide more effective analgesia, and USG-guided application might provide more precise local anesthetic spread.', 'detailedDescription': 'Unilateral Biportal Endoscopic Discectomy (UBE) has emerged as a minimally invasive and effective surgical technique for lumbar disc herniation, offering advantages such as reduced tissue trauma and faster recovery. However, despite its minimally invasive nature, patients may still experience significant postoperative pain, which can delay mobilization and discharge. The Erector Spinae Plane Block (ESPB) is a versatile regional anesthesia technique that has gained popularity for providing effective analgesia in spinal surgeries by targeting the dorsal rami of spinal nerves.\n\nConventionally, ESPB is performed by anesthesiologists using ultrasound guidance (USG) before or after the surgical procedure. However, in the context of UBE, the surgeon also has direct or endoscopic access to the anatomical landmarks required for the block. A "free-hand" ESPB performed intraoperatively by the surgeon under direct vision could potentially save time and provide similar analgesic benefits without the need for additional ultrasound equipment or preoperative intervention by the anesthesiologist.\n\nThe aim of this randomized controlled trial is to compare the postoperative analgesic efficacy of ultrasound-guided (USG) lumbar ESPB performed by an anesthesiologist versus a free-hand ESPB performed intraoperatively by the surgeon in patients undergoing UBE surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I-II.\n* Scheduled for elective UBE surgery.\n\nExclusion Criteria:\n\n* Infection at the injection site.\n* Coagulopathy or bleeding disorders.\n* Allergy to local anesthetics.\n* Chronic opioid use.\n* Cognitive dysfunction.'}, 'identificationModule': {'nctId': 'NCT07454304', 'briefTitle': 'Ultrasound-Guided vs. Surgeon-Performed (Free-hand) Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Medipol University'}, 'officialTitle': 'Comparison of Ultrasound-Guided vs. Surgeon-Performed (Free-hand) Erector Spinae Plane Block for Postoperative Analgesia in Unilateral Biportal Endoscopic Discectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'E-10840098-772.02-3995'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group US-ESPB', 'description': 'Patients in this group received an ultrasound-guided lumbar Erector Spinae Plane Block performed by an experienced anesthesiologist.', 'interventionNames': ['Drug: US-guided ESPB.']}, {'type': 'EXPERIMENTAL', 'label': 'Group Surgeon-ESPB', 'description': 'Patients in this group received a free-hand (intraoperative) lumbar Erector Spinae Plane Block performed by the neurosurgeon.', 'interventionNames': ['Drug: Surgeon-performed (Free-hand) ESPB.']}], 'interventions': [{'name': 'US-guided ESPB.', 'type': 'DRUG', 'description': 'At the end of the surgery, the patient in the prone position, an experienced anesthesiologist performed the ESPB using a low-frequency convex ultrasound probe. To avoid potential interference from surgical anatomical distortion at the operative level, the block was performed one vertebral level cranial to the surgical site. Under ultrasound guidance, the transverse process was identified, and 30 ml of 0.25% bupivacaine was injected into the fascial plane between the erector spinae muscle and the transverse process', 'armGroupLabels': ['Group US-ESPB']}, {'name': 'Surgeon-performed (Free-hand) ESPB.', 'type': 'DRUG', 'description': 'During the UBE procedure, the surgeon performed the ESPB under direct/endoscopic vision. Similar to the USG group, the injection was performed one vertebral level above the targeted surgical level to ensure optimal fascial plane spread, unaffected by surgical tissue disruption. Before wound closure, 30 ml of 0.25% bupivacaine was injected into the space between the erector spinae muscle and the transverse process.', 'armGroupLabels': ['Group Surgeon-ESPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34070', 'city': 'Istanbul', 'state': 'Bagcilar', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Medipol University Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Bahadir Ciftci', 'investigatorAffiliation': 'Medipol University'}}}}