Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-05 @ 10:44 PM
Study NCT ID:
NCT06303557
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2024-02-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of ESPB on Intraoperative Remifentanil Consumption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2024-02-26', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative remifentanil consumption', 'timeFrame': 'During the intraoperative period', 'description': 'The amount of remifentanil that patients need to maintain anesthesia during the intraoperative period will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Mean arterial pressure', 'timeFrame': 'Perioperative period', 'description': 'Mean arterial pressure values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.'}, {'measure': 'Heart rate', 'timeFrame': 'Perioperative period', 'description': 'Heart rate values will be recorded before anesthesia, before surgical incision, after surgical incision at the 5th, 30th, 60th, 90th, 120th minutes, and after general anesthesia.'}, {'measure': 'Pain scores', 'timeFrame': 'First 24 hours after surgery', 'description': 'Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain). Pain assessment will be done at the 1st, 2nd, 6th, 12th, and 24th hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lumbar Spine Surgery', 'Erector Spinae Plane Block', 'Remifentanil Consumption']}, 'descriptionModule': {'briefSummary': 'In recent years, regional anesthesia techniques have also been frequently applied to patients for pain relief. Erector spinae plane block (ESPB), is among the regional anesthesia techniques frequently used in lumbar spine surgery.\n\nGeneral anesthesia (GA) is the main method of anesthesia for lumbar spine surgery. However, GA can only inhibit the projection system of the cortical limbic system or hypothalamic cortex. GA cannot completely block the transmission of peripheral noxious stimulus to the central nervous system and cannot effectively inhibit the intraoperative stress response. With the addition of peripheral blocks such as ESPB, lower remifentanil consumption, and more stable hemodynamics are expected by providing preemptive analgesia in patients.\n\nAs a result of all these; it was aimed to compare the intraoperative remifentanil consumption of patients who underwent preoperative ESPB in patients who will undergo lumbar spine surgery resection under GA with those who underwent postoperative ESPB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years old\n* American Society of Anesthesiologists (ASA) physical status I-II-III\n* Body mass index 18 to 30 kg/m2\n* Elective lumbar disc herniation surgery\n\nExclusion Criteria:\n\n* Patient refusing the procedure\n* Patients who have previously undergone spinal surgery\n* Chronic opioid or analgesic use\n* Patients who will operate under emergency conditions\n* Patients who will not undergo lumbar disc herniation surgery'}, 'identificationModule': {'nctId': 'NCT06303557', 'briefTitle': 'Effect of ESPB on Intraoperative Remifentanil Consumption', 'organization': {'class': 'OTHER', 'fullName': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital'}, 'officialTitle': 'Effect of ESPB on Intraoperative Remifentanil Consumption in Lumbar Spine Surgery', 'orgStudyIdInfo': {'id': 'AEŞH-EK1-2023-797'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Preoperative Erector Spinae Plane Block', 'description': 'In the preoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered.', 'interventionNames': ['Drug: Preoperative Erector Spinae Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Postoperative Erector Spinae Plane Block', 'description': 'In the postoperative period, under general anesthesia, after the linear ultrasound (US) probe will be placed 2-3 cm lateral to the L3 spinous process, 15 ml of 0.25% bupivacaine will be injected into the interfacial space below the erector spinae muscle, above the transverse process. The same ESPB procedure was performed on the other side. In total, 30 ml of 0.25% bupivacaine was administered.', 'interventionNames': ['Drug: Postoperative Erector Spinae Plane Block']}], 'interventions': [{'name': 'Preoperative Erector Spinae Plane Block', 'type': 'DRUG', 'description': 'Erector spinae plane block will be performed bilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, and when the patient is placed in the prone position.', 'armGroupLabels': ['Preoperative Erector Spinae Plane Block']}, {'name': 'Postoperative Erector Spinae Plane Block', 'type': 'DRUG', 'description': 'Erector spinae plane block will be performed unilaterally, under US guidance, after the surgical operation, under general anesthesia, and when the patient is placed in the prone position.', 'armGroupLabels': ['Postoperative Erector Spinae Plane Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06170', 'city': 'Yenimahalle', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.97787, 'lon': 32.80147}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Atatürk Chest Diseases and Chest Surgery Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal İnvestigator', 'investigatorFullName': 'Musa Zengin', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}