Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT07018258
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2025-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Patient Positioning for Erector Spinae Plane Block in Laparoscopic Cholecystectomy:
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010268', 'term': 'Parapsychology'}, {'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D001525', 'term': 'Behavioral Sciences'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The person evaluating postoperative pain scores and satisfaction will be blinded to group assignment.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly assigned to receive ESP block in either the lateral, prone, or sitting position prior to laparoscopic cholecystectomy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-12-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2025-06-04', 'studyFirstSubmitQcDate': '2025-06-04', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Score (VAS)', 'timeFrame': '0, 2, 4, 6, 12, and 24 hours postoperatively', 'description': 'Pain intensity will be assessed using the Visual Analog Scale (VAS, 0-10) at multiple time points following laparoscopic cholecystectomy. The goal is to compare postoperative pain scores between patient groups receiving ESP block in lateral, prone, or sitting positions.'}], 'secondaryOutcomes': [{'measure': 'Total Postoperative Analgesic Consumption', 'timeFrame': 'First 24 hours after surgery', 'description': 'The cumulative dose (mg) of tramadol administered as rescue analgesia within the first 24 hours postoperatively will be recorded for each group.'}, {'measure': 'Time to First Analgesic Request', 'timeFrame': 'Within 24 hours postoperatively', 'description': "The duration (in minutes) between the end of surgery and the patient's first request for additional analgesia."}, {'measure': 'Patient Satisfaction Score', 'timeFrame': '24 hours postoperatively', 'description': 'Patient satisfaction will be assessed at 24 hours postoperatively using a 5-point Likert scale (1 = very dissatisfied, 5 = very satisfied).'}, {'measure': 'Skin-to-Target Distance', 'timeFrame': 'During preoperative ESP block procedure', 'description': 'The distance (in millimeters) from the skin to the ESP block site will be measured via ultrasound at the T7 level in each patient position to determine anatomical variation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Erector Spinae Plane Block', 'Patient Positioning', 'Ultrasound-Guided Regional Anesthesia'], 'conditions': ['Postoperative Pain', 'Laparoscopic Cholecystectomy', 'Anesthesia, Regional', 'Pain Management']}, 'descriptionModule': {'briefSummary': 'This randomized clinical study aims to compare the postoperative analgesic efficacy, analgesic consumption, and patient satisfaction of erector spinae plane (ESP) block administered in three different patient positions-lateral, prone, and sitting-in individuals undergoing elective laparoscopic cholecystectomy. The study also evaluates the variation in skin-to-block site distance depending on patient positioning.', 'detailedDescription': 'Erector spinae plane (ESP) block is a relatively recent regional anesthesia technique performed under ultrasound guidance, widely used for managing acute postoperative pain. While the ESP block is known for its safety, simplicity, and versatility, there is limited evidence regarding the influence of patient positioning on its clinical effectiveness and technical performance.\n\nThis prospective, randomized, single-blind study investigates the impact of administering bilateral ESP block at the T7 vertebral level in three different patient positions: lateral decubitus, prone, and sitting. The study includes adult patients (aged 18-65, ASA I-II) undergoing elective laparoscopic cholecystectomy under general anesthesia.\n\nPrimary outcomes include postoperative pain scores (VAS and NRS). Secondary outcomes include total rescue analgesic consumption (tramadol), time to first analgesic requirement, patient satisfaction scores (Likert scale), and measurement of the skin-to-block site distance across different positions. Data will be collected at defined intervals up to 24 hours postoperatively.\n\nThe findings are expected to inform clinicians on the optimal patient positioning for ESP block to enhance block efficacy and patient comfort during laparoscopic abdominal surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 65 years\n* Scheduled for elective laparoscopic cholecystectomy\n* ASA physical status I-II\n* Ability to understand and provide written informed consent\n\nExclusion Criteria:\n\n* Allergy to local anesthetics\n* History of chronic opioid use or substance abuse\n* Coagulopathy or current anticoagulant therapy\n* Local infection at the block site\n* Severe spinal deformities or scoliosis\n* BMI \\> 35 kg/m²\n* Pregnancy or breastfeeding\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT07018258', 'acronym': 'ESP-POSTURE', 'briefTitle': 'Optimal Patient Positioning for Erector Spinae Plane Block in Laparoscopic Cholecystectomy:', 'organization': {'class': 'OTHER', 'fullName': 'Harran University'}, 'officialTitle': 'Optimal Patient Positioning for Erector Spinae Plane Block: Effects on Postoperative Analgesia and Patient Satisfaction"', 'orgStudyIdInfo': {'id': 'Cevher'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lateral Position Group', 'description': 'Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.', 'interventionNames': ['Procedure: Erector Spinae Plane (ESP) Block']}, {'type': 'EXPERIMENTAL', 'label': 'Prone Position Group', 'description': 'Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.', 'interventionNames': ['Procedure: Erector Spinae Plane (ESP) Block']}, {'type': 'EXPERIMENTAL', 'label': 'Sitting Position Group', 'description': 'Patients in this group will receive bilateral erector spinae plane (ESP) block at the T7 level in the lateral decubitus position under ultrasound guidance before laparoscopic cholecystectomy.', 'interventionNames': ['Procedure: Erector Spinae Plane (ESP) Block']}], 'interventions': [{'name': 'Erector Spinae Plane (ESP) Block', 'type': 'PROCEDURE', 'otherNames': ['Ultrasound-guided ESP block'], 'description': 'Ultrasound-guided bilateral erector spinae plane (ESP) block performed at the T7 vertebral level. The intervention will be applied in three different patient positions-lateral, prone, or sitting-prior to laparoscopic cholecystectomy.', 'armGroupLabels': ['Lateral Position Group', 'Prone Position Group', 'Sitting Position Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63100', 'city': 'Sanliurfa', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Veli Fahri Pehlivan, Asisst Prof', 'role': 'CONTACT', 'email': 'vfpehlivan@harran.edu.tr', 'phone': '05327696566'}], 'facility': 'Veli Fahri Pehlivan', 'geoPoint': {'lat': 37.16708, 'lon': 38.79392}}], 'centralContacts': [{'name': 'Veli F Pehlivan, Asiss Prof', 'role': 'CONTACT', 'email': 'vfpehlivan@harran.edu.tr', 'phone': '+905327696566'}, {'name': 'Cevher Akar, Dr', 'role': 'CONTACT', 'email': 'mdcevherakar@gmail.com', 'phone': '+905446036040'}], 'overallOfficials': [{'name': 'Veli F Pehlivan, Asiss Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harran University Faculty of Medicine, Department of Anesthesiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harran University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Veli Fahri Pehlivan', 'investigatorAffiliation': 'Harran University'}}}}