Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-29 @ 4:01 PM
Study NCT ID:
NCT04442906
Status:
COMPLETED
Last Update Posted:
2021-01-25
First Post:
2020-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'anesthetist not sharing in the study will assess patient'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'analgesia for postoperative pain after knee arthroscopy: dexmedetomidine+bupivacaine, fentanyl+bupivacaine , bupivacaine'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2020-06-19', 'studyFirstSubmitQcDate': '2020-06-20', 'lastUpdatePostDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of postoperative analgesia', 'timeFrame': 'For 24 hours postoperative', 'description': 'start from intra-articular injection of the drug to the time of first request of analgesia'}], 'secondaryOutcomes': [{'measure': 'total dose of rescue analgesia ( pethidine)', 'timeFrame': 'within 24 hours postoperative', 'description': 'total consumption of rescue analgesia (pethidine) postoperative'}, {'measure': 'The number of participants with bradycardia, itching and hypotension', 'timeFrame': 'Within 24 hours postoperative', 'description': 'The number of participants with bradycardia less than 50 beat per minute, itching and hypotension if mean arterial blood pressure less than 20% of basal )'}, {'measure': 'patient satisfaction', 'timeFrame': 'within 24 hours postoperative', 'description': 'Patient satisfaction by five point Likert-Like verbal rating scale by asking the patient how they evaluate the experience with the analgesic management after the the surgery? (5-very satisfied, 4-satisfied, 3-neutral, 2-dissatisfied, 1-very dissatisfied)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'measured immediately preoperative 0 minute ( admission receiving area)', 'description': 'measured by VAS on 0-10 cm scale (0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 30 minutes postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 1 hour postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 2 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 4 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 6 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 8 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 12 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 18 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity at rest (static)', 'timeFrame': 'at 24 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'measured immediately preoperative 0 minute ( admission receiving area)', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 30 minutes postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 1 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 2 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 4 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 6 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 8 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 12 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 18 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}, {'measure': 'pain intensity on mobilization of operated knee (dynamic)', 'timeFrame': 'at 24 hours postoperative', 'description': 'measured by VAS on 0-10 cm scale(0- no pain and 10-the worst pain)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dexmedetomidine', 'fentanyl', 'bupivacaine', 'knee arthroscopy', 'postoperative analgesia'], 'conditions': ['Analgesia']}, 'referencesModule': {'references': [{'pmid': '34704709', 'type': 'DERIVED', 'citation': 'Salem DAE, Nabi SMA, Alagamy SA, Kamel AAF. Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intraarticular Bupivacaine for Postoperative Analgesia after Knee Arthroscopy. Pain Physician. 2021 Nov;24(7):E989-E996.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate analgesic effects Bupivacaine, Bupivacaine plus Dexmedetomidine and Bupivacaine plus Fentanyl in relieving pain after knee arthroscopic surgery.', 'detailedDescription': 'Forty-five patients ASA I - II aged 21-45 years for elective knee arthroscopy were divided into 3 groups: Group B, BD and BF. Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).\n\nGroup BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug). The time of first request of analgesia and analgesic effect by VAS during the first 24 hr. postoperatively are recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Either sex,\n* Age 21-45 years,\n* American Society of Anesthesia (ASA) I - II for elective knee arthroscopy.\n\nExclusion Criteria:\n\n* The patients with history of hepatic and renal diseases, psychiatric disorders,\n* Prolonged intake of (NSAIDS, opioids and tricyclic antidepressant),\n* Allergy to study drugs and patient who received analgesics up to 24 hr. before surgery were excluded from this study.'}, 'identificationModule': {'nctId': 'NCT04442906', 'briefTitle': 'Analgesia After Knee Arthroscopy :Dexmedetomidine vs Fentanyl', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Comparative Study Between Dexmedetomidine and Fentanyl as an Adjuvant to Intra-articular Bupivacaine for Postoperative Analgesia After Knee Arthroscopy.', 'orgStudyIdInfo': {'id': '5355'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group B', 'description': 'IGroup B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline', 'interventionNames': ['Drug: Bupivacain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group BD', 'description': '. Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).', 'interventionNames': ['Drug: Dexmedetomidine', 'Drug: Bupivacain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group BF', 'description': 'Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug).', 'interventionNames': ['Drug: Fentanyl', 'Drug: Bupivacain']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'otherNames': ['precedex'], 'description': 'Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).', 'armGroupLabels': ['group BD']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)', 'armGroupLabels': ['group BF']}, {'name': 'Bupivacain', 'type': 'DRUG', 'otherNames': ['marcaine'], 'description': 'Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.', 'armGroupLabels': ['group B', 'group BD', 'group BF']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig university', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Dina Salem, MD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'faculty of medicine , Zagazig University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Dina Abdelhameed Elsadek Salem', 'investigatorAffiliation': 'Zagazig University'}}}}