Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT01277835
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2010-04-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control
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'}]}}, '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': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-01', 'studyFirstSubmitDate': '2010-04-09', 'studyFirstSubmitQcDate': '2011-01-14', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verbal Rating Scale for pain with deep inspiration', 'timeFrame': 'Up to 48 hrs post-initiation of patient-controlled analgesia', 'description': 'Patients will be questioned about pain intensities with a deep inspiratory breath using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, and 48 hours post-initiaition of patient-controlled analgesia.'}, {'measure': 'PCA Morphine Consumption', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'Patient-controlled analgesia machines will be reviewed for the total morphine doses administered at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.'}, {'measure': 'Number of PCA Morphine Requests', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'PCA machines will be reviewed for total number of PCA requests at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.'}, {'measure': 'Verbal Rating Scale for pain at rest', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'Patients will be questioned about pain intensities at rest using the Verbal Rating Scale (0-10) at 8, 16, 24, 36, 48 hours post-initiation of patient-controlled analgesia.'}], 'secondaryOutcomes': [{'measure': 'Nausea', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'Patients will be questioned about the side effect of nausea at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.'}, {'measure': 'Vomiting', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'Patients will be questioned about the side effect of vomiting at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.'}, {'measure': 'Pruritus', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'Patients will be questioned about the side effect of pruritus at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.'}, {'measure': 'Constipation', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'Patients will be questioned about the side effect of constipation at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.'}, {'measure': 'Urinary Retention', 'timeFrame': 'Up to 48hrs post-initiation of patient-controlled analgesia', 'description': 'Patients will be questioned about the side effect of urinary retention at 8, 16, 24, 36, 48 hrs post-initiation of patient-controlled analgesia.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['video-assisted', 'thoracic surgery', 'VATS', 'lidocaine infusion', 'VATS procedures'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intravenous lidocaine infusion during a video-assisted chest surgery is effective in reducing the pain involved after the surgery. The hypothesis is that continuous lidocaine infusion during video-assisted thoracoscopic surgery (VATS) reduces morphine consumption and postoperative pain.', 'detailedDescription': 'Despite newer surgical techniques, many patients still experience moderate to severe postoperative pain after minimally invasive surgeries. Thoracoscopic surgeries are often associated with severe postoperative pain. To relieve the pain, potent narcotics have to be used, which have many side effects. Surgical patients would therefore benefit from an intra-operative analgesic regimen that is safe and effective, has minimal side effects and can reduce their postoperative narcotic requirements. Intravenous lidocaine has been shown previously to relieve cancer pain, chronic pain, and pain after other types of surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III\n* Age 18-75\n* Scheduled for VATS procedure\n\nExclusion Criteria:\n\n* Patients receiving antiarrhythmic therapy (Class Ia, Ib, Ic) within one week of surgery\n* Patients on preoperative analgesic therapy within one week of surgery\n* Patients with history of drug or alcohol abuse\n* Patients who are allergic to lidocaine\n* Contraindication to self administered morphine (unable to understand the PCA)\n* Progression of the procedure to thoracotomy\n* Patients who need postoperative mechanical ventilation\n* Necessary major deviation from the intraoperative study protocol as per the discretion of the anesthesiologist in charge of the case\n* Patients who are breastfeeding or pregnant\n* Patient refusal'}, 'identificationModule': {'nctId': 'NCT01277835', 'briefTitle': 'Intravenous Lidocaine Infusion During Video-assisted Thoracic Procedures for Improved Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Intravenous Lidocaine Infusion During VATS Procedures Reduces Postoperative Analgesic Requirements', 'orgStudyIdInfo': {'id': 'VATS-lidocaine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine Infusion', 'interventionNames': ['Drug: Lidocaine Infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline Infusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lidocaine Infusion', 'type': 'DRUG', 'description': 'Infusion of lidocaine 3mg/min or 2mg/min during surgery', 'armGroupLabels': ['Lidocaine Infusion']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Saline Infusion at same rate as experimental arm', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7M 0Z9', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': "St. Paul's Hospital", 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Dennis Ong, MD FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan, Department of Anesthesiology, Perioperative Medicine, and Pain Management'}, {'name': 'Brian Taylor, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Perioperative Medicine, and Pain Management'}, {'name': 'Ashraf Salem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Perioperative Medicine, and Pain Management'}, {'name': 'Mark Slovack, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Anesthesiology, Perioperative Medicine, and Pain Management'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}