Viewing Study NCT05004532


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Study NCT ID: NCT05004532
Status: COMPLETED
Last Update Posted: 2021-08-25
First Post: 2021-06-04
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Transversus Abdominis Plane Block in Acute Appendicitis Pain Managment
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}, {'id': 'D000006', 'term': 'Abdomen, Acute'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D059413', 'term': 'Intraabdominal Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002429', 'term': 'Cecal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-22', 'studyFirstSubmitDate': '2021-06-04', 'studyFirstSubmitQcDate': '2021-08-09', 'lastUpdatePostDateStruct': {'date': '2021-08-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verbal Numerical Pain Scale', 'timeFrame': 'postoperative time 24 hour time', 'description': '\\<4 good pain managment , \\>4-10 bad pain managment'}], 'secondaryOutcomes': [{'measure': 'BMI', 'timeFrame': 'preoperative', 'description': 'kg/(m2)'}, {'measure': 'weight', 'timeFrame': 'preoperative', 'description': 'kg'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transversus abdominis plane nerve block', 'acute appendicitis', 'acute pain', 'postoperative pain'], 'conditions': ['Acute Appendicitis', 'Acute Abdomen', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'In this study, it was aimed to investigate the analgesic efficacy of the preoperatively applied Transversus Abdominis Plane (TAP) Block in the management of acute appendicitis-related abdominal pain and post-appendectomy pain.', 'detailedDescription': 'TAP block creates an analgesic effect by blocking both sensory skin dermotams and viscerosomatic transmission. TAP block with ultrasound was first performed by Hebbard, and the use of USG made the procedure faster and safer. TAP block has been successfully applied for analgesia in procedures such as laparoscopic colocystectomy, inguinal hernia repair, abdominal hysterectomy, prostatectomy and appendectomy. According to the surgical incision to be applied, TAP block is performed from different anatomical regions. It is also applied for pain palliation in intra-abdominal etiologies or rarely for anesthesia in surgical procedures.\n\nThe analgesic efficacy of TAP block on preoperative abdominal pain and postoperative surgical pain in acute appendicitis was investigated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years and older who underwent open appendectomy with the diagnosis of acute appendicitis, who underwent TAP block, were identified retrospectively. Demographic data of the patients, change of pain scores at rest and with coughing, postoperative pain scores, postoperative analgesic need were evaluated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients over the age of 18 with a diagnosis of acute appendicitis,\n* with abdominal pain,\n* tap block applied for perioperative pain management.\n\nExclusion Criteria:\n\n* The data of patients who underwent laparoscopic appendectomy\n* additional surgical procedure other than appendectomy (right hemicolectomy, etc.)\n* who were diagnosed other than acute appendicitis after the surgical procedure (diverticulitis, tumor, etc.),'}, 'identificationModule': {'nctId': 'NCT05004532', 'briefTitle': 'Transversus Abdominis Plane Block in Acute Appendicitis Pain Managment', 'organization': {'class': 'OTHER', 'fullName': 'Erol Olcok Corum Training and Research Hospital'}, 'officialTitle': 'Efficacy of Preoperative Transversus Abdominis Plane Block in Acute Appendicitis Pain and Its Success in Postoperative Pain', 'orgStudyIdInfo': {'id': '19/08/2020 - 223'}}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erol Olcok Corum Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor M.D. Hulya TOPCU', 'investigatorFullName': 'HULYA TOPCU', 'investigatorAffiliation': 'Erol Olcok Corum Training and Research Hospital'}}}}