Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-27 @ 4:18 AM
Study NCT ID:
NCT05547659
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2022-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal and Unimodal Analgesia in Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069583', 'term': 'Pregabalin'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D013607', 'term': 'Tablets'}, {'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2022-08-25', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reported opioid side effects', 'timeFrame': '24 hour postoperative', 'description': 'Side effects reported after opioid administration eg. nausea, vomiting, respiratory depression etc..'}], 'primaryOutcomes': [{'measure': 'Postoperative visual analogue scale (VAS)', 'timeFrame': '24 hour postoperative', 'description': 'The visual analog scale (VAS) is a simple and often used method for evaluating variations in pain intensity.'}, {'measure': 'Amount of post operative Needed opioid analgesia', 'timeFrame': '24 hour postoperative', 'description': 'ampules of opioid analgesia needed after operation'}], 'secondaryOutcomes': [{'measure': 'Type and amount of prescribed post operative non opioid analgesia', 'timeFrame': '24 hour postoperative', 'description': 'Type and amount of prescribed post operative non opioid analgesia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Compare Unimodal and Multimodal Analgesics']}, 'descriptionModule': {'briefSummary': 'Many surgical procedures are accompanied by postoperative pain with severity moderate, severe or extreme and insufficient postoperative pain control may cause risk of post-surgical complications and risk of chronic post-surgical pain The targets of preoperative pain management are to relieve patient suffering, reduce length of hospital stay and achieve early mobilization after surgery, decreasing opioid consumption and its side effects that are constipation, nausea, vomiting, dizziness, respiratory depression which is the most feared complication being life-threatening and some less common side effects as sedation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing laparoscopic cholecystectomy\n* Patients older than 18 years old\n\nExclusion Criteria:\n\n* Renal or hepatic or cardiac impairment patients\n* Patients with chronic pain history\n* Allergic patients after taking aspirin or other NSAIDs\n* patients with active gastrointestinal bleeding, ulcer and inflammatory bowel diseases or cerebrovascular bleeding'}, 'identificationModule': {'nctId': 'NCT05547659', 'briefTitle': 'Multimodal and Unimodal Analgesia in Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'October 6 University'}, 'officialTitle': 'Comparison Between Multimodal and Unimodal Analgesia in Cholecystectomy', 'orgStudyIdInfo': {'id': 'FWA00015574'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'multimodal', 'description': 'pregabalin/ acetaminophen/ celecoxib', 'interventionNames': ['Drug: Pregabalin 150mg', 'Drug: Acetaminophen 1 G Oral Tablet', 'Drug: Celecoxib 400Mg Oral Capsule']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'unimodal', 'description': 'Pregabalin', 'interventionNames': ['Drug: Pregabalin 150mg']}, {'type': 'NO_INTERVENTION', 'label': 'control'}], 'interventions': [{'name': 'Pregabalin 150mg', 'type': 'DRUG', 'description': 'Pregabalin 150mg preoperative in unimodal group Pregabalin 150mg preoperative in multi-modal group', 'armGroupLabels': ['multimodal', 'unimodal']}, {'name': 'Acetaminophen 1 G Oral Tablet', 'type': 'DRUG', 'description': 'Acetaminophen 1 G Oral Tablet preoperative in multi-modal group', 'armGroupLabels': ['multimodal']}, {'name': 'Celecoxib 400Mg Oral Capsule', 'type': 'DRUG', 'description': 'Celecoxib 400Mg Oral Capsule preoperative in multi-modal group', 'armGroupLabels': ['multimodal']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Beni suef University hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}, {'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'Beni-Suef Hospital', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October 6 University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beni-Suef University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'head of clinical pharmacy unit', 'investigatorFullName': 'engy wahsh', 'investigatorAffiliation': 'October 6 University'}}}}