Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT05094193
Status:
UNKNOWN
Last Update Posted:
2021-10-26
First Post:
2021-10-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trocar-site Infiltration Versus TAP-block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-13', 'studyFirstSubmitDate': '2021-10-03', 'studyFirstSubmitQcDate': '2021-10-13', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute postoperative pain', 'timeFrame': 'up to 24 hours', 'description': 'Visual analog scale (VAS) 0: "no pain" to 10: "severe pain" at rest and cough'}, {'measure': 'Total opioid consumption', 'timeFrame': 'Day 1'}], 'secondaryOutcomes': [{'measure': 'Length of hospital stay', 'timeFrame': 'up to 1 week'}, {'measure': 'postoperative nausea and vomiting', 'timeFrame': 'Day 1'}, {'measure': 'Patient satisfaction and quality of recovery', 'timeFrame': 'Day 1', 'description': 'QoR-40 questionnaire'}, {'measure': 'Incidence of shoulder pain', 'timeFrame': 'Day 1'}, {'measure': 'Postoperative complication', 'timeFrame': 'up to 1 week', 'description': 'Ileus, wound infection, wound abscess'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acute pain management', 'Ropivacaine', 'Trocar-site infiltration', 'TAP-block', 'Laparoscopic cholecystectomy'], 'conditions': ['Laparoscopic Cholecystectomy']}, 'descriptionModule': {'briefSummary': 'For symptomatic gall bladder disorders (cholelithiasis and cholecystitis), laparoscopic cholecystectomy (LC) has been considered as the gold standard treatment. However, these minimally invasive technique is associated with acute moderate pain during the 24 hours postoperative, which is routinely managed using opioids. The transversus abdominis plane (TAP) block has been used as part of a multimodal analgesia strategy. Besides, Wang et al found that TAP block is more effective than a conventional pain control, but not significatively different from another local incisional pain control that is port site infiltration.So, the aim of this study, is to compare the analgesic efficacy and safety of trocar-site infiltration with ropivacaine with ultrasound-guided TAP block following laparoscopic cholecystectomy when used as part of multimodal analgesia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\< 30 kg/m2\n* Scheduled for laparoscopic cholecystectomy\n* ASA grade I, II and III\n\nExclusion Criteria:\n\n* Bile duct exploration, insertion of a T-drain or patients with acute cholecystitis\n* Conversion to open cholecystectomy or if the surgery exceeded 200 minutes\n* Severe systemic disease\n* Patients on analgesics for any reason\n* History of allergy to local anesthetics\n* An ongoing pregnancy\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT05094193', 'briefTitle': 'Trocar-site Infiltration Versus TAP-block', 'organization': {'class': 'OTHER', 'fullName': 'Tunis University'}, 'officialTitle': 'Trocar-site Infiltration With Ropivacaine Versus Tranversus Abdominis Plane Block Following Laparoscopic Cholecystectomy: a Double-blinded, Randomized-controlled Trial', 'orgStudyIdInfo': {'id': 'HTHEC-2021-29'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Trocar-site infiltration', 'description': 'Trocar-site infiltration with 20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 5 mm trocar site) associated with bilateral TAP block with 20 mL of normal saline in each side', 'interventionNames': ['Procedure: Trocar-site infiltration', 'Procedure: TAP block placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block', 'description': 'Trocar-site infiltration with 20 mL of normal saline associated with bilateral TAP block with 20 mL of ropivacaine 0.375% in each side', 'interventionNames': ['Procedure: TAP block', 'Procedure: Trocar site infiltration placebo']}], 'interventions': [{'name': 'Trocar-site infiltration', 'type': 'PROCEDURE', 'description': '20 mL of ropivacaine 0.375% (6 mL in 10 mm trocar site and 4 mL in 6 mm trocar site)', 'armGroupLabels': ['Trocar-site infiltration']}, {'name': 'TAP block', 'type': 'PROCEDURE', 'description': 'bilateral ultrasound-guided TAP block with 20 mL of ropivacaine 0.375% in each side', 'armGroupLabels': ['TAP block']}, {'name': 'Trocar site infiltration placebo', 'type': 'PROCEDURE', 'description': '20 mL of normal saline', 'armGroupLabels': ['TAP block']}, {'name': 'TAP block placebo', 'type': 'PROCEDURE', 'description': 'bilateral ultrasound-guided TAP block with 20 mL of normal saline in each side', 'armGroupLabels': ['Trocar-site infiltration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tunis', 'status': 'RECRUITING', 'country': 'Tunisia', 'contacts': [{'name': 'Mohamed Aziz Daghmouri', 'role': 'CONTACT', 'email': 'aziz.daghmouri@gmail.com'}], 'facility': 'Habib Thameur Hospital', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'centralContacts': [{'name': 'DAGHMOURI Mohamed Aziz, M.D', 'role': 'CONTACT', 'email': 'aziz.daghmouri@gmail.com', 'phone': '0029442474'}], 'overallOfficials': [{'name': 'BEN FADHEL Kamel, M.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Habib Thameur Hospital of Tunis, Department of Anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tunis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Daghmouri Mohamed Aziz', 'investigatorAffiliation': 'Tunis University'}}}}