Ignite Creation Date:
2025-12-26 @ 3:59 PM
Ignite Modification Date:
2025-12-29 @ 6:37 AM
Study NCT ID:
NCT05034406
Status:
COMPLETED
Last Update Posted:
2021-09-05
First Post:
2021-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014646', 'term': 'Varicocele'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002045', 'term': 'Bupivacaine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-02', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-09-02', 'lastUpdatePostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain (as measured by Visual analogue scale)', 'timeFrame': '6 hours after surgery', 'description': 'Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.'}], 'secondaryOutcomes': [{'measure': 'Pain (as measured by Visual analogue scale)', 'timeFrame': '2 hours after surgery', 'description': 'Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.'}, {'measure': 'Pain (as measured by Visual analogue scale)', 'timeFrame': '12 hours after surgery', 'description': 'Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.'}, {'measure': 'Pain (as measured by Visual analogue scale)', 'timeFrame': '24 hours after surgery', 'description': 'Visual analogue scale (VAS, 0-10 scale with 10 being the strongest pain) of pain assessed by a blinded investigator.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Varicocele', 'Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Aim of this study is to examine the effects of subcutaneously applied local anesthetics at trocar site in combination with intraoperative intraperitoneal analgesia on duration and character of pain in pediatric patients undergoing laparoscopic varicocelectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients with varicocele who underwent laparoscopic varicocelectomy\n* pediatric patients whose parents or guardians gave informed consent\n\nExclusion Criteria:\n\n* patients who received open or microsurgical varicocelectomy\n* pediatric patients who underwent conversion to open procedure\n* pediatric patients with chronic, metabolic and endocrine diseases\n* pediatric patients with systemic infections'}, 'identificationModule': {'nctId': 'NCT05034406', 'briefTitle': 'The Effect of Subcutaneous and Intraperitoneal Anesthesia on Post Laparoscopic Pain', 'organization': {'class': 'OTHER', 'fullName': 'KBC Split'}, 'officialTitle': 'The Effect of Subcutaneous and Intraperitoneal Instillation of Local Anesthetics on Postoperative Pain After Laparoscopic Varicocelectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '500-03/20-01/09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine group', 'description': 'A total amount of 6 mL of 2% lidocaine was injected at the three trocar insertion sites (2 mL at each insertion site) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.', 'interventionNames': ['Drug: 2% Lidocaine']}, {'type': 'EXPERIMENTAL', 'label': 'Levobupivacaine', 'description': 'Total amount of 6 mL of 0.5% levobupivacaine was injected at the three trocar insertion sites (2 mL at each) prior to incision and 10 mL of 2% lidocaine was injected at the end of procedure, under the direct visualization of laparoscope, below and around the defect of the peritoneum at the site of varicocele.', 'interventionNames': ['Drug: 0.5% levobupivacaine']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'No local or peritoneal administration of any local anesthetic prior, during and after the surgical procedure'}], 'interventions': [{'name': '2% Lidocaine', 'type': 'DRUG', 'description': '6 mL of 2% lidocaine injected at the trocar insertion site.', 'armGroupLabels': ['Lidocaine group']}, {'name': '0.5% levobupivacaine', 'type': 'DRUG', 'description': '6 mL of 0.5% levobupivacaine injected at the trocar insertion site.', 'armGroupLabels': ['Levobupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Split', 'state': 'Split-Dalmatia County', 'country': 'Croatia', 'facility': 'University Hospital Split', 'geoPoint': {'lat': 43.50891, 'lon': 16.43915}}], 'overallOfficials': [{'name': 'Zenon Pogorelić, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Split, School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'KBC Split', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical doctor, surgery resident', 'investigatorFullName': 'Goran Tintor', 'investigatorAffiliation': 'KBC Split'}}}}