Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:32 PM
Study NCT ID:
NCT07431905
Status:
COMPLETED
Last Update Posted:
2026-02-25
First Post:
2026-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Erector Spinae Plane Block on Postoperative Analgesia and Stress Response in Laparoscopic Sleeve Gastrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2024-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2026-01-27', 'studyFirstSubmitQcDate': '2026-02-18', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Numerical Rating Scale (NRS)', 'timeFrame': '24 hours after surgery', 'description': 'The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain intensity.'}], 'secondaryOutcomes': [{'measure': 'Body Weight (kilograms)', 'timeFrame': 'At baseline (preoperatively)', 'description': 'Body weight measured in kilograms (kg) using a calibrated hospital scale. Higher values indicate greater body weight.'}, {'measure': 'Height (centimeters)', 'timeFrame': 'At baseline (preoperatively)', 'description': 'Height measured in centimeters (cm) using a standard stadiometer. Higher values indicate greater height.'}, {'measure': 'Body Mass Index (BMI, kg/m²)', 'timeFrame': 'At baseline (preoperatively)', 'description': 'Calculated as weight (kg) divided by height squared (m²).'}, {'measure': 'Postoperative Rescue Opioid Consumption (Intravenous Tramadol, mg)', 'timeFrame': 'During the first 24 hours postoperatively'}, {'measure': 'Perioperative Heart Rate (beats per minute)', 'timeFrame': 'Intraoperatively and during the first 24 hours postoperatively'}, {'measure': 'Mean Arterial Pressure (mmHg)', 'timeFrame': 'Intraoperatively and during the first 24 hours postoperatively'}, {'measure': 'Patient Satisfaction Assessed by a 5-Point Likert Scale at 24 Hours', 'timeFrame': '24 hours postoperatively', 'description': '5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied). Higher scores indicate greater satisfaction.'}, {'measure': 'Serum Cortisol Level (mg/dL)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}, {'measure': 'Serum C-Reactive Protein (CRP) Level (mg/L)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}, {'measure': 'Blood Glucose Level (mg/dL)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}, {'measure': 'White Blood Cell Count (×10³/mm³)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}, {'measure': 'Lymphocyte Percentage (%)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}, {'measure': 'Absolute Lymphocyte Count (×10³/mm³)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}, {'measure': 'Neutrophil Percentage (%)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}, {'measure': 'Absolute Neutrophil Count (×10³/mm³)', 'timeFrame': 'From preoperative baseline to 24 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Sleeve Gastrectomy', 'Erector Spina Plan Block', 'Cortisol', 'Numerical Rating Scale', 'Opioid Analgesia']}, 'descriptionModule': {'briefSummary': 'Effective postoperative analgesia is an important component of enhanced recovery after bariatric surgery. The erector spinae plane block (ESPB) is a regional anesthesia technique that has been increasingly used in abdominal and thoracic surgeries; however, its effects on postoperative analgesic requirements, pain scores, patient and surgeon satisfaction, hemodynamic parameters, and perioperative stress response in obese patients undergoing sleeve gastrectomy require further evaluation.\n\nThis study is designed as a prospective, randomized, single-blind clinical trial. After obtaining ethics committee approval (Şanlıurfa Harran University Hospital, date: 23.01.2023; decision no: HRÜ/23.02.09) and written/verbal informed consent, 60 patients aged 18-65 years, with a body mass index (BMI) \\>30 and classified as ASA II-III, scheduled for elective sleeve gastrectomy will be included. Patients will be randomized into two groups: a group receiving bilateral ESPB (Group E, n=30) and a control group without ESPB (Group C, n=30).\n\nDemographic characteristics, ASA classification, comorbidities, and duration of surgery will be recorded. Preoperative venous blood samples will be collected for hemogram (white blood cell count, lymphocyte count, neutrophil count) and biochemical analyses (C-reactive protein, cortisol, and glucose). Standard intraoperative monitoring (electrocardiography, peripheral oxygen saturation, and noninvasive blood pressure) will be applied, and heart rate (HR) and mean arterial pressure (MAP) will be recorded intraoperatively.\n\nPostoperatively, HR and MAP, Numerical Rating Scale (NRS) pain scores at 0, 2, 4, 8, and 24 hours, opioid consumption, patient and surgeon satisfaction scores (Likert scale), postoperative hemogram and biochemical parameters, and any side effects or complications will be documented. All patients will receive dexketoprofen as baseline analgesia, and tramadol hydrochloride will be administered as rescue analgesic when required.\n\nThe primary objective of the study is to compare postoperative pain scores and analgesic requirements between patients receiving bilateral ESPB and those not receiving ESPB. Secondary objectives include the assessment of hemodynamic parameters, patient and surgeon satisfaction, and perioperative hematologic, biochemical, and stress-related parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Body mass index (BMI) \\> 30 kg/m²\n* ASA physical status II-III\n* Scheduled for elective laparoscopic sleeve gastrectomy under general anesthesia\n* Ability to provide written and verbal informed consent\n\nExclusion Criteria:\n\n* Age \\< 18 years or \\> 65 years\n* ASA physical status I, IV, or V\n* Body mass index (BMI) \\< 30 kg/m²\n* Contraindications to erector spinae plane block (e.g., infection at injection site, coagulopathy, allergy to local anesthetics)\n* Renal or hepatic insufficiency\n* Refusal to participate or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07431905', 'briefTitle': 'Effect of Erector Spinae Plane Block on Postoperative Analgesia and Stress Response in Laparoscopic Sleeve Gastrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Harran University'}, 'officialTitle': 'Impact of Erector Spinae Plane Block on Postoperative Analgesia and Perioperative Stress Response in Sleeve Gastrectomy: A Prospective Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'HRÜ/23.02.09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group ESPB', 'interventionNames': ['Procedure: Erector Spinae Plane Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group Control', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'Erector Spinae Plane Block', 'type': 'PROCEDURE', 'description': 'Patients in the intervention group received a preoperative bilateral ultrasound-guided erector spinae plane block (ESPB) in addition to standardized general anesthesia and multimodal analgesia. The block was performed 30 minutes before surgery in the preoperative area by an experienced anesthesiologist under aseptic conditions. With the patient in the prone position, a linear ultrasound probe was placed at the T7-T8 vertebral level to identify the transverse process and erector spinae muscle. Using an in-plane technique, a 22-gauge, 100-mm needle was advanced to the transverse process, and 20 mL of a local anesthetic mixture (lidocaine 2%, bupivacaine 0.25%, and saline) was injected into the fascial plane deep to the erector spinae muscle on each side. Dermatomal sensory assessment was performed before transfer to the operating room. All patients subsequently underwent identical general anesthesia protocols. The control group did not receive any regional block and was managed with the', 'armGroupLabels': ['Group ESPB']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'Patients allocated to the control group received standardized general anesthesia and postoperative multimodal analgesia without any regional anesthesia technique. No erector spinae plane block or other peripheral nerve block was performed. General anesthesia induction and maintenance protocols were identical to those used in the intervention group, ensuring comparable intraoperative management. At the end of surgery, all patients received intravenous tramadol as part of the standardized analgesic regimen. Postoperatively, scheduled non-opioid analgesia was administered to all patients. Intravenous tramadol was provided as rescue analgesia when Numerical Rating Scale (NRS) pain scores were ≥4 or upon patient request. Perioperative monitoring, postoperative assessments, and data collection procedures were identical between groups.', 'armGroupLabels': ['Group Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01360', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Harran University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harran University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Kutay Baris FILAZI', 'investigatorAffiliation': 'Harran University'}}}}