Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-01-08 @ 4:13 PM
Study NCT ID:
NCT04922359
Status:
UNKNOWN
Last Update Posted:
2021-06-10
First Post:
2021-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults
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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'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', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-06', 'studyFirstSubmitDate': '2021-06-06', 'studyFirstSubmitQcDate': '2021-06-06', 'lastUpdatePostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First anal exhaust time', 'timeFrame': 'Day 0', 'description': 'Time of first anal exhaust after operation'}], 'secondaryOutcomes': [{'measure': 'First defecation time', 'timeFrame': 'Day 0', 'description': 'Time of first defecation after operation'}, {'measure': 'First diet time', 'timeFrame': 'Day 0', 'description': 'Time of first feeding after operation'}, {'measure': 'Time to get out of bed', 'timeFrame': 'Day 0', 'description': 'Time to get out of bed after operation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lidocaine', 'Gastrointestinal Dysfunction', 'Spinal surgery', 'Opioid consumption'], 'conditions': ['Spinal Surgery', 'Lidocaine', 'Pain', 'Opioid Consumption', 'Gastrointestinal Dysfunction']}, 'descriptionModule': {'briefSummary': 'Spinal surgery often involves multiple segments. The trauma of surgery is large, the duration of postoperative pain is long, and the pain is severe. Therefore, the use of opioids in perioperative period is large. Although the application of \\* large amounts of opioids can effectively inhibit pain, it will delay the recovery of urine retention, sedation, respiratory depression and gastrointestinal function. The delayed recovery of gastrointestinal function will increase the postoperative complications, and then increase the length of hospital stay and the cost of patients. Therefore, reducing the dosage of opioids to promote the recovery of gastrointestinal function has become the research direction. Intravenous lidocaine has been proved to be effective in reducing the dosage of opioids during the perioperative period of gastrointestinal surgery and promoting the recovery of postoperative gastrointestinal function. However, there are few studies on the application of lidocaine during the perioperative period of spinal surgery, especially the impact on postoperative gastrointestinal function. In this study, a multicenter, randomized, double-blind, controlled study was conducted to explore the effect of perioperative lidocaine on the recovery of gastrointestinal function after adult lumbar surgery. We hypothesized that lidocaine could shorten the recovery time of gastrointestinal function after lumbar surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age 60 to 80;\n2. ASA physical status score of I, II or III;\n3. Scheduled to undergo a posterior lumbar surgery;\n4. Ideal body weight≤80 kg;\n\nExclusion Criteria:\n\n1. Those who are refused to be included;\n2. Those who are allergic to the drugs used in this study;\n3. Emergency operation\n4. Degree II or III atrioventricular block\n5. heart failure\n6. History of ALS, preexcitation or active dysrhythmia\n7. Severe liver injury (bilirubin \\> 1.46 mg/dl)\n8. Severe renal injury (creatinine clearance \\< 30 ml/min) or Renal failure\n9. History of epilepsy\n10. History of porphyria\n11. Preoperative hypotension (SBP\\< 90mmHg)\n12. Drug contraindications of NSAIDs\n13. Allergic to anaesthetic'}, 'identificationModule': {'nctId': 'NCT04922359', 'briefTitle': 'Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Effect of Perioperative Lidocaine on Gastrointestinal Function Recovery After Lumbar Spine Surgery in Adults: a Multicenter, Randomized, Double-blind, Controlled Study', 'orgStudyIdInfo': {'id': '2021PHB059-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Lidocaine group', 'interventionNames': ['Drug: Lidocain']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: comparator group', 'interventionNames': ['Drug: normal saline']}], 'interventions': [{'name': 'Lidocain', 'type': 'DRUG', 'description': 'Patients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance.', 'armGroupLabels': ['Experimental: Lidocaine group']}, {'name': 'normal saline', 'type': 'DRUG', 'description': 'Patients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance.', 'armGroupLabels': ['Placebo Comparator: comparator group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jie Gu, attending', 'role': 'CONTACT', 'email': 'hmugujie@163.com', 'phone': '15210886376'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Wangjing Hospital, China Academy of Chinese Medical Sciences', 'class': 'OTHER'}, {'name': 'First Affiliated Hospital of Guangxi Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Anesthesiology', 'investigatorFullName': 'Yi Feng, MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}