Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 11:29 AM
Study NCT ID:
NCT05448469
Status:
COMPLETED
Last Update Posted:
2022-12-23
First Post:
2022-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2022-07-02', 'studyFirstSubmitQcDate': '2022-07-02', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First time to analgesic requirement', 'timeFrame': '1st 24 hour', 'description': 'all patients received an IV -PCA system (Accufuser M8P, 60 mL; Woo Young Meditech Co, S.Korea). PCA was prepared with 60 mL of isotonic saline containing 60 mg morphine, and the selected system was adjusted to infuse a 1 mL bolus dose with a lockout interval of 15 minutes while the basal flow rate was switched off. Breakthrough pain was managed with 2mg morphine.'}], 'secondaryOutcomes': [{'measure': 'total analgesic consumption', 'timeFrame': '1st 24 hour', 'description': 'The total dose of rescue analgesics(morphine) required in 24 hours will be recorded.'}, {'measure': 'Numerical rating scale (NRS)', 'timeFrame': '1st 24 hour', 'description': 'All patients will be monitored in the postoperative period for pain by the NRS score at rest and movement at immediate postoperative (0 min), 30 min, 1, 2, 6,12, and 24 hours.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'There are very few randomized controlled trials in open splenectomy surgery, which compare paravertebral block with ESP block. The purpose of this randomized controlled trial is to compare the efficacy of ultrasound-guided paravertebral block with ESP block for perioperative analgesia in open splenectomy .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients who will be scheduled for indicated open splenectomy surgery in the supine position via left subcostal ,midline or letf subcostal with midline extention incisions\n* physical status American Society of Anesthesiologists (ASA) II or III.\n\nExclusion Criteria:\n\n* Patients who refuse to participate\n* patients with body mass index (BMI) \\>35 kg/m2\n* infection at the site of injection\n* coagulopathy, severe thrombocytopenia \\<50×103\n* spine deformity\n* history of opioid dependence\n* polytrauma patients with dorsal spine fracture\n* urgent abdominal exploration for splenectomy in heamodynamically unstable patients\n* history of allergy to opioids or local anesthetics\n* history of allergy to opioids, or local anaesthetics.'}, 'identificationModule': {'nctId': 'NCT05448469', 'briefTitle': 'Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia in Patients Undergoing Open Splenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Ultrasound-guided Erector Spinae Plane Block Versus Paravertebral Block for Perioperative Analgesia, a Randomized Double Blinded Controlled Trial', 'orgStudyIdInfo': {'id': 'R 97/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'general anesthesia+ bilateral US guided erector spinae plane block', 'description': 'General anesthesia plus ultrasound guided erector spinae plane block with 20 ml bupivacaine 0.2% at T9', 'interventionNames': ['Procedure: ultrasound guided erector spinae plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'general anesthesia+ bilateral US guided paravertebral block', 'description': 'General anesthesia plus bilateral US guided paravertebral block with 7 ml bupivacaine 0.2% at T8 and T10', 'interventionNames': ['Procedure: ultrasound guided paravertebral block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'general anesthesia', 'description': 'general anesthesia plus conventional analgesia', 'interventionNames': ['Drug: conventional analgesia']}], 'interventions': [{'name': 'ultrasound guided erector spinae plane block', 'type': 'PROCEDURE', 'description': 'patients will receive combined general anesthesia and ultrasound guided erector spinae plane block with 20 ml of bupivacaine 0.2 % at T9 level bilaterally.', 'armGroupLabels': ['general anesthesia+ bilateral US guided erector spinae plane block']}, {'name': 'ultrasound guided paravertebral block', 'type': 'PROCEDURE', 'description': 'patients will receive combined general anesthesia and ultrasound guided paravertebral block with 7 ml of bupivacaine 0.2 % at T8 and T10 bilaterally.', 'armGroupLabels': ['general anesthesia+ bilateral US guided paravertebral block']}, {'name': 'conventional analgesia', 'type': 'DRUG', 'description': 'patients will receive combined general anesthesia and conventional analgesia', 'armGroupLabels': ['general anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Amin Mohammed Alansary Amin Ahmed Helwa', 'investigatorAffiliation': 'Ain Shams University'}}}}