Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2026-02-25 @ 8:50 PM
Study NCT ID:
NCT02653651
Status:
COMPLETED
Last Update Posted:
2016-07-28
First Post:
2016-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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': 'D007649', 'term': 'Ketamine'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-26', 'studyFirstSubmitDate': '2016-01-01', 'studyFirstSubmitQcDate': '2016-01-09', 'lastUpdatePostDateStruct': {'date': '2016-07-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': '24 hours', 'description': 'the total amount of morphine consumed during follow up period'}], 'secondaryOutcomes': [{'measure': 'Postoperative nausea and vomiting using a Verbal Rating Scale', 'timeFrame': '48 hours', 'description': 'Investigators will ask patients to grade the severity of their nausea and vomiting episodes using a verbal rating scale'}, {'measure': 'Functional recovery assessed by 6 minute walk test (6MWT)', 'timeFrame': 'the fourth postoperative morning'}, {'measure': 'chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4)', 'timeFrame': 'At 3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Ketamine', 'Lidocaine', 'Nephrectomy', 'Chronic pain'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. The open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. Adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. Preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons.\n\nKetamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. The investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy.\n\nThe investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. All patients will receive normal "patient-controlled analgesia morphine" in addition to study drugs or placebo. Research will be conducted at Charles Nicolle teaching hospital.', 'detailedDescription': 'Participants will be randomized into one of three study groups: Group L: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months, patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4 questionnaire.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult (\\>/=18)\n2. male or female\n3. Undergoing elective open nephrectomy\n4. General anesthesia\n5. Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2.\n\nExclusion Criteria:\n\n1. Pregnancy and breastfeeding\n2. Cognitively impaired (by history)\n3. Subject with a history of psychosis\n4. Subject known to have significant hepatic disease\n5. History of previous cardiac arrhythmia\n6. Subject for whom opioids or ketamine are contraindicated'}, 'identificationModule': {'nctId': 'NCT02653651', 'briefTitle': 'Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'University Tunis El Manar'}, 'officialTitle': 'A Comparison Between the Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy: A Prospective, Double-blind, Randomized, Placebo Controlled Study', 'orgStudyIdInfo': {'id': 'UTuniselmanar'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ketamine', 'description': 'Ketamine infused at 0.1 mg/kg/hour', 'interventionNames': ['Drug: Ketamine']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine', 'description': 'Lidocaine infused at 1 mg/kg/hour', 'interventionNames': ['Drug: Lidocaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'An equal volume of saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ketamine', 'type': 'DRUG', 'description': 'Ketamine infused at 0.1 mg/kg/hour', 'armGroupLabels': ['Ketamine']}, {'name': 'Lidocaine', 'type': 'DRUG', 'description': 'Lidocaine infused at 1 mg/kg/hour', 'armGroupLabels': ['Lidocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'An equal volume of saline', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1006', 'city': 'Tunis', 'state': 'Tunis Governorate', 'country': 'Tunisia', 'facility': 'Ali JENDOUBI', 'geoPoint': {'lat': 36.81897, 'lon': 10.16579}}], 'overallOfficials': [{'name': 'Ali JENDOUBI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Tunis El Manar'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Tunis El Manar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Assistant Professor', 'investigatorFullName': 'Ali JENDOUBI', 'investigatorAffiliation': 'University Tunis El Manar'}}}}