Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT05097118
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2021-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2023-09-13', 'releaseDate': '2022-11-04'}], 'estimatedResultsFirstSubmitDate': '2022-11-04'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001064', 'term': 'Appendicitis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-16', 'studyFirstSubmitDate': '2021-10-17', 'studyFirstSubmitQcDate': '2021-10-17', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison study between Ketamine and Bupivacaine for post operative analgesia', 'timeFrame': 'one year', 'description': 'Analgesia for post -operative Appendectomy operation'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Appendicitis Acute']}, 'referencesModule': {'references': [{'pmid': '22227789', 'type': 'BACKGROUND', 'citation': 'American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.'}, {'pmid': '11460814', 'type': 'BACKGROUND', 'citation': 'Kehlet H, Holte K. Effect of postoperative analgesia on surgical outcome. Br J Anaesth. 2001 Jul;87(1):62-72. doi: 10.1093/bja/87.1.62. No abstract available.'}, {'pmid': '24911371', 'type': 'BACKGROUND', 'citation': 'Barrington JW, Dalury DF, Emerson RH Jr, Hawkins RJ, Joshi GP, Stulberg BN. Improving patient outcomes through advanced pain management techniques in total hip and knee arthroplasty. Am J Orthop (Belle Mead NJ). 2013 Oct;42(10 Suppl):S1-S20.'}, {'pmid': '17673581', 'type': 'BACKGROUND', 'citation': 'Baker PN, van der Meulen JH, Lewsey J, Gregg PJ; National Joint Registry for England and Wales. The role of pain and function in determining patient satisfaction after total knee replacement. Data from the National Joint Registry for England and Wales. J Bone Joint Surg Br. 2007 Jul;89(7):893-900. doi: 10.1302/0301-620X.89B7.19091.'}]}, 'descriptionModule': {'briefSummary': 'surgical site infiltration using ketamine versus Bupivacaine for analgesia in post-operative Appendectomy operation by Ketamine versus Bupivacaine'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 60 adult patients with ASA physical physical status class 1 and class 2 undergoing uncomplicated appendectomy under general anesthesia\n\nExclusion Criteria:\n\n* Patient refusal\n* drug abuse\n* Patient with neurological, psychiatirc or neuromuscular disease\n* chronic pain on medicine\n* known allergy to the study medicine\n* Infection at the site of infiltration'}, 'identificationModule': {'nctId': 'NCT05097118', 'briefTitle': 'Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Surgical Site Infiltration Using Ketamine Versus Bupivacaine for Analgesia in Post-operative Appendectomy Operation', 'orgStudyIdInfo': {'id': 'Soh-Med-21-10-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group of Ketamine injection', 'description': 'Ketamine infiltration for post operative analgesia', 'interventionNames': ['Drug: Ketamine Versus Bupivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Group of Bupivacaine injection', 'description': 'Bupivacaine infiltration for post operative analgesia', 'interventionNames': ['Drug: Ketamine Versus Bupivacaine']}], 'interventions': [{'name': 'Ketamine Versus Bupivacaine', 'type': 'DRUG', 'description': 'Drugs Ketamine versus Bupivacaine', 'armGroupLabels': ['Group of Bupivacaine injection', 'Group of Ketamine injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'resident doctor at Anaesthesia and ICU department sohag university hospital', 'investigatorFullName': 'Gehad Ahmed Aly', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-11-04', 'type': 'RELEASE'}, {'date': '2023-09-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gehad Ahmed Aly, resident doctor at Anaesthesia and ICU department sohag university hospital, Sohag University'}}}}