Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT05706233
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2023-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002764', 'term': 'Cholecystitis'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D005705', 'term': 'Gallbladder Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 108}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-27', 'studyFirstSubmitDate': '2023-01-09', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2023-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'effect of ESPB applied postoperatively on the meperidine consumption in PACU', 'timeFrame': '1 HOUR', 'description': "As part of the standardized perioperative care management, the pain intensity is evaluated with the numeric pain rating scale (NRS). If the NRS is \\> 3 meperidine bolus or ESPB is applied in line with the patients' selection and the patients are evaluated in every 5 min in terms of their NRS scores until NRS \\< 4 is achieved. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied. All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS \\> 3, 20 mg if NRS \\> 5, 30 mg if NRS \\> 8. NRS scores and meperidine boluses applied are recorded on the PACU follow-up form."}], 'secondaryOutcomes': [{'measure': 'effect of ESPB applied postoperatively on numeric rating scores in PACU', 'timeFrame': '1 HOUR', 'description': "As part of the standardized perioperative care management, the pain intensity is evaluated with the numeric pain rating scale (NRS). If the NRS is \\> 3 meperidine bolus or ESPB is applied in line with the patients' selection and the patients are evaluated in every 5 min in terms of their NRS scores until NRS \\< 4 is achieved. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied. All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS \\> 3, 20 mg if NRS \\> 5, 30 mg if NRS \\> 8. NRS scores and meperidine boluses applied are recorded on the PACU follow-up form."}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Regional Anesthesia Morbidity', 'Cholecystitis, Chronic']}, 'descriptionModule': {'briefSummary': 'Laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases.\n\nErector spinae plane block (ESPB) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due to its safety applicability, and effect on both the visceral and parietal component of pain by providing paravertebral, transforaminal and epidural spread. Preoperative application of ESPB has taken its place as a part of multimodal analgesia in laparoscopic cholecystectomy cases over time and has been shown to reduce postoperative pain scores and opioid consumption and to improve quality of recovery scores. However, there is no data regarding the use of ESPB in the postoperative period as a rescue therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing laparoscopic cholecystectomy', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic cholecystectomy\n* Patients with NRS\\>3 scores in the PACU\n\nExclusion Criteria:\n\n* ASA \\> 2\n* Violation of standart protocol (anesthesia and analgesia)\n* application of ESPB preoperatively\n* age \\> 65\n* Surgery duration \\>90min or \\<45min'}, 'identificationModule': {'nctId': 'NCT05706233', 'briefTitle': 'Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul Saglik Bilimleri University'}, 'officialTitle': 'Effect of Postoperative Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy: A Historical Cohort Study', 'orgStudyIdInfo': {'id': '2021.11.254'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Erector Spina Plane Block (ESPB)', 'interventionNames': ['Procedure: Erector Spina Plane Group']}, {'label': 'Intravenous Group (IV)', 'interventionNames': ['Procedure: IV analgesic intervention']}], 'interventions': [{'name': 'Erector Spina Plane Group', 'type': 'PROCEDURE', 'description': 'ESPB had been applied postoperatively: from T8 level, 20mL bupivacaine %0,5 + 5ml %2 lidocaine was applied.', 'armGroupLabels': ['Erector Spina Plane Block (ESPB)']}, {'name': 'IV analgesic intervention', 'type': 'PROCEDURE', 'description': 'IV analgesics had been applied: All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS \\> 3, 20 mg if NRS \\> 5, 30 mg if NRS \\> 8. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied.', 'armGroupLabels': ['Intravenous Group (IV)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Basaksehir Cam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul Saglik Bilimleri University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Taner Abdullah', 'investigatorAffiliation': 'Istanbul Saglik Bilimleri University'}}}}