Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-02 @ 5:04 AM
Study NCT ID:
NCT06865469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-07
First Post:
2025-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-04', 'studyFirstSubmitDate': '2025-03-04', 'studyFirstSubmitQcDate': '2025-03-04', 'lastUpdatePostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score NRS score', 'timeFrame': '24 hours', 'description': 'The severity of pain will be assessed postoperatively using a 10 cm NRS (0 = no pain and 10 = worst imaginable pain) at rest and coughing at 0, 2nd, 4th, 6th, 12th, 18th, and 24th hours'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fracture Hip Surgery']}, 'descriptionModule': {'briefSummary': "Perioperative pain management has been a major challenge for anesthesiologists, and there have been persistent efforts to bring out the best possible analgesic technique with the least side effects.\n\nHip fractures are devastating injuries, constituting a global public health burden and remain one of the largest healthcare challenges of the 21st century. The incidence increases with advancing age and the number of hip fractures is expected to increase to 6.26 million per year in 2050.\n\nHip fractures impact on patient's psychological, functional, and social wellbeing, and account for substantial healthcare system costs.\n\nDrugs of potential interest such as intravenous (i.v.) lidocaine and dexmedetomidine have been administered both intra and/or postoperatively to decrease perioperative pain and improve other outcomes. Lidoocaine has analgesic, anti inflammatory, and anti hyperalgesia properties.\n\nSeveral studies have demonstrated that perioperative lidocaine infusion reduces postoperative pain intensity and opioid consumption .\n\nEase of availability, cost effectiveness, simplicity of administration, safety, and analgesic action make lignocaine an attractive option.\n\nDexmedetomidine is a highly selective and specific α2 adrenoceptor agonist with useful analgesic, sedative, anxiolytic, and sympatholytic properties.\n\nI.V. dexmedetomidine has gained immense popularity owing to its efficacy as an analgesic adjuvant, translating into reduced opioid consumption.\n\nIntraoperative dexmedetomidine and lignocaine also confirm the enhanced recovery after surgery protocol advocating the reduction of opioid use.\n\nWhile numerous studies have analyzed i.v. lidoocaine and dexmedetomidine versus placebo regarding postoperative analgesia and outcomes, researches and evidence in the context of minimally invasive surgeries regarding adverse effect profile, postoperative analgesic requirement, perioperative analgesia, anesthesia recovery, and opioid requirements are always welcome(rephrase). Our study was conducted to analyze the effects of intraoperative i.v. lidocaine and dexmedetomidine on pain relief, intra- and postoperative opioid consumption, and effects of these infusions on intraoperative hemodynamic parameters and to evaluate the side effect profiles the aim of the study to analyze the effects of intraoperative intravenous lignocaine/dexmedetomidine on postoperative pain relief and analgesit consumption"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18 years old.\n* patients with both sex\n* patients who are American society of Anesthesiologists class I or II\n\nExclusion Criteria:\n\nrefusal.\n\n* body mass index (BMI) ≥40 kg/m2.\n* History of hypersensitivity to the drugs being evaluated\n* Inability to comprehend postoperatively the pain assessment scale/neuropsychiatric disorders.\n* chronic use of opioids and opioid addiction'}, 'identificationModule': {'nctId': 'NCT06865469', 'briefTitle': 'Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery', 'orgStudyIdInfo': {'id': 'Dex vs lidocaine fracture hip'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group D', 'description': 'patients will recive dexmedetomidine i.v. infusion at 0.4 μg/kg/h', 'interventionNames': ['Drug: Dexmedetomidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group L', 'description': 'patients will received 1.5 mg/kg/h lidocaine hydrochloride 2% (400 mg/20 mL) by i.v. infusion.', 'interventionNames': ['Drug: Lidocaine Hydrochloride 2%']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'dexmedetomidine will be administered by i.v. infusion at 0.4 μg/kg/h', 'armGroupLabels': ['Group D']}, {'name': 'Lidocaine Hydrochloride 2%', 'type': 'DRUG', 'description': 'lidocaine hydrochloride 2% (400 mg/20 mL) 1.5 mg/kg/h by i.v. infusion.', 'armGroupLabels': ['Group L']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'residant doctor at Assiut university hospital', 'investigatorFullName': 'Hisham Mamdouh Kotp Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}