Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2025-12-26 @ 6:32 PM
Study NCT ID:
NCT05225766
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2021-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Erector Spinae Plane Block and Rectus Sheath Block
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': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-02', 'studyFirstSubmitDate': '2021-11-08', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative hemodynamic data and administered opioid doses', 'timeFrame': '150 minutes', 'description': 'Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.'}, {'measure': 'postoperative visual analog scales at rest and during coughing', 'timeFrame': '48 hours', 'description': 'Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.'}, {'measure': 'time to first patient controlled analgesia (PCA) dose', 'timeFrame': '48 hours', 'description': 'The times when patients used the PCA device for the first time were recorded and compared between groups.'}, {'measure': 'postoperative morphine consumption', 'timeFrame': '48 hours', 'description': 'Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.'}, {'measure': 'need for rescue analgesics', 'timeFrame': '48 hours', 'description': "Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration."}, {'measure': 'duration time until first mobilization', 'timeFrame': '48 hours', 'description': 'The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.'}, {'measure': 'opioid side effects', 'timeFrame': '48 hours', 'description': 'Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.'}, {'measure': 'patient and surgeon satisfaction', 'timeFrame': '48 hours', 'description': 'Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae plane block', 'rectus sheath block', 'pain management', 'midline laparotomy'], 'conditions': ['Postoperative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.', 'detailedDescription': "Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-75 years\n* American Society of Anesthesiologists (ASA) classes I-III\n\nExclusion Criteria:\n\n* Local anesthetic allergy\n* Coagulopathy\n* Injection site infection\n* History of abdominal surgery\n* Severe neurological or psychiatric disorder\n* Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate \\<15 ml/min/1.73 m2)\n* chronic opioid use'}, 'identificationModule': {'nctId': 'NCT05225766', 'briefTitle': 'Comparison of Erector Spinae Plane Block and Rectus Sheath Block', 'organization': {'class': 'OTHER', 'fullName': 'Uludag University'}, 'officialTitle': 'Comparison of Intraoperative and Postoperative Effects of Erector Spinae Plane Block and Rectus Sheath Block', 'orgStudyIdInfo': {'id': 'TurkishARD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group ESPB', 'description': 'Erector spinae plane block', 'interventionNames': ['Other: bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group RSB', 'description': 'Rectus sheath block', 'interventionNames': ['Other: bupivacaine']}], 'interventions': [{'name': 'bupivacaine', 'type': 'OTHER', 'description': 'used for peripheral block', 'armGroupLabels': ['Group ESPB', 'Group RSB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16059', 'city': 'Bursa', 'state': 'Nilüfer', 'country': 'Turkey (Türkiye)', 'facility': 'Bursa Uludag University', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}], 'overallOfficials': [{'name': 'Emre SALMAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Uludag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Emre Salman', 'investigatorAffiliation': 'Uludag University'}}}}