Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-27 @ 1:42 PM
Study NCT ID:
NCT03420703
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2018-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2018-01-29', 'lastUpdatePostDateStruct': {'date': '2018-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '24h morphine consumption', 'timeFrame': 'for postoperative 24 hour', 'description': 'morphine consumptions for both group will be recorded'}], 'secondaryOutcomes': [{'measure': 'Postoperative nausea and vomiting', 'timeFrame': '24 hour', 'description': 'PONV after surgery was questioned'}, {'measure': 'Pain', 'timeFrame': '24h', 'description': 'Numeric rating scales were recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['erector spinae plane block', 'laparoscopic cholecystectomy', 'postoperative pain'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 25 - 75 years of age\n* ASA I - II\n* Undergoing elective laparoscopic cholecystectomy\n\nExclusion Criteria:\n\n* obesity\n* ASA III - IV\n* infection of the skin at the site of needle puncture area\n* patients with known allergies to any of the study drugs\n* coagulopathy\n* recent use of analgesic drugs'}, 'identificationModule': {'nctId': 'NCT03420703', 'briefTitle': 'Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'The Effect of Erector Spinae Plane Block on Postoperative Pain Following Laparoscopic Cholecystectomy: A Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2017-349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Block group', 'description': 'Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively', 'interventionNames': ['Other: erector spinae plane block', 'Device: Intravenous morphine patient controlled analgesia device']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'An intravenous patient controlled analgesia device will be given to the patients postoperatively', 'interventionNames': ['Device: Intravenous morphine patient controlled analgesia device']}], 'interventions': [{'name': 'erector spinae plane block', 'type': 'OTHER', 'description': 'ultrasound guided erector spinae plane block will be administered to this group.', 'armGroupLabels': ['Block group']}, {'name': 'Intravenous morphine patient controlled analgesia device', 'type': 'DEVICE', 'description': 'Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded', 'armGroupLabels': ['Block group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41340', 'city': 'İzmit', 'state': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University Hospital', 'geoPoint': {'lat': 40.76499, 'lon': 29.92928}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Can AKSU', 'investigatorAffiliation': 'Kocaeli University'}}}}