Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT03955705
Status:
UNKNOWN
Last Update Posted:
2020-09-04
First Post:
2019-05-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-05-04', 'releaseDate': '2021-04-09'}], 'estimatedResultsFirstSubmitDate': '2021-04-09'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D009340', 'term': 'Nefopam'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D010079', 'term': 'Oxazocines'}, {'id': 'D001392', 'term': 'Azocines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2019-05-07', 'studyFirstSubmitQcDate': '2019-05-17', 'lastUpdatePostDateStruct': {'date': '2020-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine consumption', 'timeFrame': '24 hours', 'description': 'Intravenous morphine was given to all by patient controlled analgesia (PCA) machine. The higher morphine consumption reflects higher postoperative pain.'}], 'secondaryOutcomes': [{'measure': 'The change in Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score)', 'timeFrame': '30 days', 'description': 'Changes in NPSI-T (minimum 0- maximum 100) period by recording NPSI-T at preoperative period, compared with postoperative day 1, 3, 15,30. The total score is 100, the higher scores reflect higher neuropathic pain'}, {'measure': 'The change in pain scores', 'timeFrame': '72 hours', 'description': 'Changes in pain scores (minimum 0- maximum 10) at different time point 0 (upon arrival to recovery room), postoperative at 4, 8, 12, 16, 24, 48, 72 hours. The higher scores reflect higher pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Spine Degeneration']}, 'referencesModule': {'references': [{'pmid': '12377921', 'type': 'BACKGROUND', 'citation': 'Rao R. Neck pain, cervical radiculopathy, and cervical myelopathy: pathophysiology, natural history, and clinical evaluation. J Bone Joint Surg Am. 2002 Oct;84(10):1872-81. doi: 10.2106/00004623-200210000-00021. No abstract available.'}, {'pmid': '7864317', 'type': 'BACKGROUND', 'citation': 'Dordoni PL, Della Ventura M, Stefanelli A, Iannace E, Paparella P, Rocca B, Accorra F. Effect of ketorolac, ketoprofen and nefopam on platelet function. Anaesthesia. 1994 Dec;49(12):1046-9. doi: 10.1111/j.1365-2044.1994.tb04352.x.'}, {'pmid': '1102231', 'type': 'BACKGROUND', 'citation': 'Sunshine A, Laska E. Nefopam and morphine in man. Clin Pharmacol Ther. 1975 Nov;18(5 Pt 1):530-4. doi: 10.1002/cpt1975185part1530.'}, {'pmid': '24748937', 'type': 'RESULT', 'citation': 'Kim KH, Abdi S. Rediscovery of nefopam for the treatment of neuropathic pain. Korean J Pain. 2014 Apr;27(2):103-11. doi: 10.3344/kjp.2014.27.2.103. Epub 2014 Mar 28.'}, {'pmid': '28039239', 'type': 'RESULT', 'citation': 'Martinez V, Beloeil H, Marret E, Fletcher D, Ravaud P, Trinquart L. Non-opioid analgesics in adults after major surgery: systematic review with network meta-analysis of randomized trials. Br J Anaesth. 2017 Jan;118(1):22-31. doi: 10.1093/bja/aew391.'}]}, 'descriptionModule': {'briefSummary': 'Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine. It has no respiratory depression so may be useful in potential airway compromized surgery like anterior cervical discectomy and fusion (ACDF). This study aims to study the analgesic properties of nefopam after ACDF.', 'detailedDescription': 'The investigators enroll 50 patient who admitted for ACDF. Standard general anesthesia will be performed in all of the patients. Then, an hour before finishing operation, the patients will be divided into two groups. The first group will receive Nefopam 20 mg infuse for 60 min. The another group or group NSS will receive the same amount of 0.9% sodium chloride. The recorded data include patient demographic data, intraoperative blood loss, hemodynamics and pre and postoperative pain scores and Thai version of the Neuropathic Pain Symptom Inventory (NPSI-T score).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cervical spondylosis or cervical spondylotic myelopathy undergoing elective anterior cervical spine surgery such as ACDF or anterior cervical corpectomy and fusion (ACCF)\n* American Society of Anesthesiologists (ASA) class I-III\n* Age 18-75 years old\n* Body weight \\> 50 kg, BMI \\< 30 kg/m2\n\nExclusion Criteria:\n\n* Convulsion or seizure\n* Myocardial ischemia or infarction\n* Risk of urinary retention from urethral disease or prostate disease\n* Angle closure glaucoma\n* Patients on monoamine oxidase inhibitor\n* Psychiatric patients\n* Pregnant or lactated woman\n* Creatinine clearance \\< 30 ml/min\n* Allergic to nefopam\n* Patients on pregabaline or gabapentin\n* Poorly controlled hypertension\n* Cannot understand or do the questionnaire of Thai version of Neuropathic pain symptom inventory (NPSI-T) score'}, 'identificationModule': {'nctId': 'NCT03955705', 'briefTitle': 'Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Analgesic Effectiveness of Nefopam in Patients Undergoing Anterior Cervical Spine Surgery', 'orgStudyIdInfo': {'id': 'Si204/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nefopam', 'description': 'Nefopam: 20 mg (infuse at least 15 minutes) every 4-6 hours, max 120 mg/day', 'interventionNames': ['Drug: Nefopam 20 mg/ml']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal saline solution', 'description': 'Normal saline or 0.9% Sodium Chloride (NaCl) or NSS', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Nefopam 20 mg/ml', 'type': 'DRUG', 'otherNames': ['Acupan'], 'description': 'Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine.', 'armGroupLabels': ['Nefopam']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['0.9% NaCl or NSS'], 'description': '0.9% Sodium chloride (normal saline or NSS)', 'armGroupLabels': ['Normal saline solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Siriraj Hospital Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Manee Raksakietisak, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mahidol University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-04-09', 'type': 'RELEASE'}, {'date': '2021-05-04', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mahidol University'}}}}