Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT00728559
Status:
UNKNOWN
Last Update Posted:
2011-02-03
First Post:
2008-08-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-02-02', 'studyFirstSubmitDate': '2008-08-01', 'studyFirstSubmitQcDate': '2008-08-05', 'lastUpdatePostDateStruct': {'date': '2011-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative pain measured by VAS', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'total analgesics required, patient recovery, patient satisfaction', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['laparoscopy', 'preemptive', 'postoperative', 'pain', 'trocar', 'site'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'In the literature there is conflicting data on administration of local analgesia in addition to the general anesthesia to the trocar sites during laparoscopy, We believe that adding local analgesia to the general anesthesia during laparoscopy is beneficial . the current study will evaluate prospectivly the impact of local analgesia on postoperative pain and recovery in patients undergoing operative laparoscopy', 'detailedDescription': 'Methods: this is a blinded prospective randomized study. After approval of IRB and informed consent 120 patients undergoing for laparoscopy will be randomized after the induction of general anesthesia into three groups: Group A will receive preemptive analgesia using 3-5 cc of 0,5 % marcaine at the beginning of the procedure. Group 2 will receive a local analgesia using 3-5 cc marcaine at the end of the procedure. Group 3 will be operated under general anesthesia only. The post operative pain and patient recovery will be assessed by the nurses during the hospitalization using a VAS (Visual Analog Scale) the total analgetic drugs will be noted and after the patients discharge the patient status and satisfaction will be evaluated by phone up to 2 wks'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female older then 18 y/o\n\nExclusion Criteria:\n\n* Allergy to marcaine'}, 'identificationModule': {'nctId': 'NCT00728559', 'briefTitle': 'Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy', 'organization': {'class': 'OTHER_GOV', 'fullName': 'The Baruch Padeh Medical Center, Poriya'}, 'officialTitle': 'Evaluation of Local Anlagesia Into the Trocar Site During Operative Laparosocpy', 'orgStudyIdInfo': {'id': 'lapmar1.CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'preemptive trocar site analgesia', 'interventionNames': ['Drug: bupivacain 0.5%']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'trocar site pre skin closure analgesia', 'interventionNames': ['Drug: bupivacain 0.5%']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'control'}], 'interventions': [{'name': 'bupivacain 0.5%', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': 'trocar site injection', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15208', 'city': 'Tiberias', 'state': 'Lower Galilee', 'country': 'Israel', 'contacts': [{'name': 'ilan Atlas, MD', 'role': 'CONTACT', 'email': 'ilanatlas@yahoo.com', 'phone': '01197249080914'}, {'name': 'Samer Tannus, MD', 'role': 'CONTACT', 'email': 'stannus@bezeqint.co.il', 'phone': '01197246652565'}, {'name': 'Ilan Atlas, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Poria Gov Hospital', 'geoPoint': {'lat': 32.79221, 'lon': 35.53124}}], 'centralContacts': [{'name': 'Ilan atlas, md', 'role': 'CONTACT', 'email': 'ilanatlas@yahoo.com', 'phone': '011972506267421'}, {'name': 'samer tannus, md', 'role': 'CONTACT', 'email': 'stannus@bezeqint.net', 'phone': '01197249540410'}], 'overallOfficials': [{'name': 'Ilan Atlas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Ministry of Health, Israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Baruch Padeh Medical Center, Poriya', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Ministry of Health, Israel', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Ilan Atlas, MD Gynecologic Oncology Director', 'oldOrganization': 'Poria Medical Center'}}}}