Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-02-20 @ 2:37 AM
Study NCT ID:
NCT01387568
Status:
COMPLETED
Last Update Posted:
2012-04-20
First Post:
2011-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Infusion for Major Abdominal Pediatric Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-18', 'studyFirstSubmitDate': '2011-06-29', 'studyFirstSubmitQcDate': '2011-07-01', 'lastUpdatePostDateStruct': {'date': '2012-04-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'for 2hrs after infusion'}], 'secondaryOutcomes': [{'measure': 'Plasma Cortisol', 'timeFrame': 'for 24 hrs after infusion'}, {'measure': 'Serum lidocaine', 'timeFrame': '6 hrs after infusion', 'description': 'The TDx/ TDx FLx (Abbot Diagnostic, USA) lidocaine assay was used for quantitative measurement of serum lidocaine'}, {'measure': 'Heart rate (HR)', 'timeFrame': 'for 6 hrs after infusion'}, {'measure': 'Pain scales', 'timeFrame': '24 hrs postoperative', 'description': 'In the postanaesthetic care unit (PACU), children were assessed for pain every 10 min by the trained nurse blinded to group assignment, using 1 of 2 pain scales according to child comprehension: a 0- to 10-point visual analog scale (VAS), or FLACC Scale (Face, Legs,Activity, Cry, Consolability). FLACC is an observer assessment based 5 items and each item is graded from 0 to 2'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Elective Major Abdominal Surgery']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.', 'detailedDescription': 'The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.\n\nIntravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pediatric\n* Abdominal surgery\n* ASA class I and II\n\nExclusion Criteria:\n\n* history of hepatic diseases\n* history of cardiac diseases\n* history of renal diseases\n* allergy to local anesthetics\n* epilepsy'}, 'identificationModule': {'nctId': 'NCT01387568', 'briefTitle': 'Lidocaine Infusion for Major Abdominal Pediatric Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'The Effects of Intravenous Lidocaine Infusion During and After Major Abdominal Pediatric Surgery. A Randomized Double-blinded Study', 'orgStudyIdInfo': {'id': 'MUH-AD-1-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group L', 'description': 'Lidocaine group', 'interventionNames': ['Drug: Lidocaine Infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'group P', 'description': 'Placebo group', 'interventionNames': ['Drug: saline Infusion']}], 'interventions': [{'name': 'Lidocaine Infusion', 'type': 'DRUG', 'description': 'children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively', 'armGroupLabels': ['group L']}, {'name': 'saline Infusion', 'type': 'DRUG', 'description': 'children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively', 'armGroupLabels': ['group P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Anesthesia Dept, Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Alaa El Deep, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'alaaeldeep9@hotmail.com'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology', 'investigatorFullName': 'Mohamed R El Tahan', 'investigatorAffiliation': 'Mansoura University'}}}}