Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
Study NCT ID:
NCT03847792
Status:
COMPLETED
Last Update Posted:
2020-09-11
First Post:
2019-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-09', 'studyFirstSubmitDate': '2019-02-19', 'studyFirstSubmitQcDate': '2019-02-19', 'lastUpdatePostDateStruct': {'date': '2020-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of postoperative analgesia', 'timeFrame': 'for 24 hour after surgery', 'description': 'Time to the first request of pethidine in minutes within the first 24 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'Total analgesic requirement', 'timeFrame': 'for 24 hour after surgery', 'description': 'Total analgesic requirement of pethidine will be recorded during the first 24 hours following surgery'}, {'measure': 'Mean arterial blood pressure', 'timeFrame': 'At 1,2,4,6,8,12,18 and 24 hours postoperatively.', 'description': 'Mean arterial blood pressure measured in mm Hg and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.'}, {'measure': 'Heart rate', 'timeFrame': 'At 1,2,4,6,8,12,18 and 24 hours postoperatively.', 'description': 'Heart rate will be measured in beats/minute and assessed at 1,2,4,6,8,12,18 and 24 hours following the discharge of the patient from the operating theatre.'}, {'measure': 'Pain score', 'timeFrame': 'measured at 1,2,4,6,8,12,18 and 24 hours postoperatively.', 'description': 'Measured with visual analogue score(VAS):0=no pain and 100=worst imaginable pain measured at 1,2,4,6,8,12,18 and 24 hours'}, {'measure': "Patients' satisfaction", 'timeFrame': 'for 24 hour after surgery', 'description': 'satisfaction score from 1 to 4; as 4=Excellent ,3=good ,2=satisfactory and 1=poor will be measured after 24 hours.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Knee Arthroscopic Surgery']}, 'descriptionModule': {'briefSummary': 'However, local anesthetic agents can produce analgesia for a limited time when used as a single injection. Bupivacaine is a local anesthetic that has an immediate action on pain by blocking peripheral afferents. However, as the ideal analgesic, the drug must cover the whole postoperative period (≥ 24 hours); therefore, bupivacaine is usually combined with many adjutants to provide long-lasting post-arthroscopy analgesia.', 'detailedDescription': 'Intr-articular drug administration has gained popularity because of its simplicity and efficacy in achieving anesthesia for diagnostic and operative arthroscopy and for providing postoperative analgesia .although the knee joint has been examined most commonly, arthroscopy of other joints such as shoulder, ankle, wrist, metatarsophalangeal and temporomandibular joints is being increasingly used.\n\nIntra-articular installation of local anesthesia during arthroscopic procedures has been used by many orthopedic surgeons to provide pain relief after surgery.The aim of this study was to evaluate the analgesic efficacy of intra-articular dexamethasone versus fentanyl added as an adjuvant to bupivacaine in patients undergoing knee arthroscopic surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists physical status (ASA) I or II\n\nExclusion Criteria:\n\n* Contraindication to spinal anesthesia.\n* Allergy to the study drugs.\n* Refusal of the patients.'}, 'identificationModule': {'nctId': 'NCT03847792', 'briefTitle': 'Analgesic Effect Of Intra-articular Bupivacaine Fentanyl for Postoperative Pain Relief in Knee Arthroscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Analgesic Effect Of Intra-articular Dexamethasone Versus Fentanyl Added as an Adjuvant to Bupivacaine for Postoperative Pain Relief in Knee Arthroscopic Surgery', 'orgStudyIdInfo': {'id': 'MS/18.09.306'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group DB/Dexamethasone-Bupivacaine', 'description': 'Patients were received an intra-articular injection of 8mg dexamethasone added to18mL of 0.25% bupivacaine', 'interventionNames': ['Drug: Group DB/Dexamethasone-Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group FB /Fentanyl-Bupivacaine', 'description': 'Patients were received an intra-articular injection of 1 ug/kg fentanyl added to 18 mL of 0.25% bupivacaine', 'interventionNames': ['Drug: Group FB /Fentanyl-Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group PB/Placebo-Bupivacaine', 'description': 'Patients were received an intra-articular injection of 2 mL isotonic saline added to 18 mL of 0.25% bupivacaine', 'interventionNames': ['Drug: Group PB/Placebo-Bupivacaine']}], 'interventions': [{'name': 'Group DB/Dexamethasone-Bupivacaine', 'type': 'DRUG', 'description': 'The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.', 'armGroupLabels': ['Group DB/Dexamethasone-Bupivacaine']}, {'name': 'Group FB /Fentanyl-Bupivacaine', 'type': 'DRUG', 'description': 'The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.', 'armGroupLabels': ['Group FB /Fentanyl-Bupivacaine']}, {'name': 'Group PB/Placebo-Bupivacaine', 'type': 'DRUG', 'description': 'Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.', 'armGroupLabels': ['Group PB/Placebo-Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'facility': 'Mohamed A Sultan', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}, {'zip': '050', 'city': 'Al Mansurah', 'state': 'Eastern', 'country': 'Egypt', 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Mohamed M Sultan, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of Anaesthesia and Surgical Intensive Care'}, {'name': 'Hazem ESM Weheba, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant Professor of Anaesthesia and Surgical Intensive Care'}, {'name': 'Hosam Ibrahim EL said saber, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Anaesthesia and Surgical Intensive Care'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'forever', 'ipdSharing': 'YES', 'description': 'Following publication', 'accessCriteria': 'tawfik20192@gmail.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}