Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT04061057
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2019-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], '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': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-16', 'studyFirstSubmitDate': '2019-08-12', 'studyFirstSubmitQcDate': '2019-08-16', 'lastUpdatePostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fentanyl requirement using IV PCA', 'timeFrame': '24hours after surgery', 'description': 'Dose of fentanyl infused via IV PCA machine during first 24 hours after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rotator Cuff Tears']}, 'referencesModule': {'references': [{'pmid': '34636752', 'type': 'DERIVED', 'citation': 'Kim SJ, Choi YS, Chun YM, Kim HJ, Han C, Shin S. Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia: A Randomized Controlled Trial. Clin J Pain. 2021 Oct 12;38(1):1-7. doi: 10.1097/AJP.0000000000000995.'}]}, 'descriptionModule': {'briefSummary': 'Arthroscopic rotator cuff repair is a commonly performed procedure but is known to cause significant postoperative pain. Effective analgesia after rotator cuff repair is crucial in improving the well-being of the patient but also to ensure long-term rehabilitation. The most commonly used analgesic for acute postoperative pain is opioids. However, the use of opioids is accompanied by several side effects which include but are not limited to nausea/vomiting, urinary retention, itching sensation and sometimes dizziness, respiratory depression and hypotension in higher doses. As of late, many efforts are aimed toward decreasing the use of opioids by using multimodal analgesia. Among such methods, intravenous lidocaine has been reported to be effective, safe and economic in various procedures. However, the existing evidence is mostly focused on laparoscopic procedures. The present study aims to find whether perioperative infusion of lidocaine is able to decrease opioid requirements after surgery and also improve postoperative pain compared to placebo in patients undergoing arthroscopic rotator cuff repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. ASA class 1-3 adults over 19 years scheduled for elective arthroscopic rotator cuff repair\n\nExclusion Criteria:\n\n1. Known allergies to lidocaine or propofol\n2. Cardia arrhythmia\n3. History of epilepsy or seizures\n4. Liver/kidney failure\n5. History of recent strong opioid use'}, 'identificationModule': {'nctId': 'NCT04061057', 'briefTitle': 'Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Perioperative Intravenous Lidocaine Infusion on Postoperative Recovery in Patients Undergoing Arthroscopic Rotator Cuff Repair Under General Anesthesia', 'orgStudyIdInfo': {'id': '4-2018-0033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IV lidocaine', 'description': 'Perioperative IV lidocaine infusion', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline', 'description': 'Perioperative IV normal saline infusion', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Drug: 1. Lidocaine Intravenous lidocaine bolus of 1.5mg/kg immediately after anesthesia induction followed by infusion at 2.0mg/kg/hr up to 1 hr after end of surgery.\n\n2\\. Fentanyl IV infusion via PCA (patient controlled analgesia) machine of fentanyl 10 μg/ml, ramosetron 0.3 mg, normal saline, total 100 ml, infusion rate 1 ml/hr, 1 ml bolus and lockout time 7 min.', 'armGroupLabels': ['IV lidocaine']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': 'Drug: 1. Normal saline Intravenous normal saline bolus of immediately after anesthesia induction followed by infusion up to 1 hr after end of surgery. Volume of normal saline is equal to lidocaine.\n\n2\\. Fentanyl IV infusion via PCA (patient controlled analgesia) machine of fentanyl 10 μg/ml, ramosetron 0.3 mg, normal saline, total 100 ml, infusion rate 1 ml/hr, 1 ml bolus and lockout time 7 min.', 'armGroupLabels': ['Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}