Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-03-01 @ 11:27 AM
Study NCT ID:
NCT02135120
Status:
COMPLETED
Last Update Posted:
2019-01-10
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Efficacy of Peripheral Nerve Blocks With Intrathecal Morphine in Improving Analgesia After Unilateral Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2014-05-07', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative parenteral morphine consumption', 'timeFrame': 'first 24 hours post-operation'}], 'secondaryOutcomes': [{'measure': 'Visual analogue pain scores (VAS) in anterior and posterior knee', 'timeFrame': 'within 24-48 hours after surgery'}, {'measure': 'Severity of pain in anterior and posterior knee', 'timeFrame': '1 week postoperatively'}, {'measure': 'Time to first IV PCA bolus', 'timeFrame': 'within first 12 hours'}, {'measure': 'Total IV PCA consumption upon discontinuation of PCA', 'timeFrame': '24-48 hours after surgery'}, {'measure': 'Side effects', 'timeFrame': 'within 24 hours after surgery', 'description': 'Patients will be closely monitored during their hospital stay. Patients will be assessed in their rooms twice daily by a pain nurse, and additionally as required, to report the occurrence of side effects including: block complications, incidence of falls, numbness over femoral distribution, nausea \\& vomiting, pruritus, occurrence of urinary retention, occurrence of respiratory depression.'}, {'measure': 'Patient satisfaction with pain control', 'timeFrame': '24-48 hours after surgery'}, {'measure': 'complications', 'timeFrame': '1 month after surgery', 'description': 'Patients will be contacted by a member of the research team (by phone) to check for complications including: numbness in the anterior thigh, numbness in the foot, pain and/or bruising around the site where the anesthetic were injected, weakness in thigh muscles, weakness in foot muscles'}]}, 'conditionsModule': {'conditions': ['Anesthesia', 'Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intrathecal morphine (ITM) alone or its combination with peripheral nerve blocks (PNB) provides better analgesia for patients undergoing total knee arthroplasty (TKA).', 'detailedDescription': 'Total knee arthroplasty (TKA) surgery is associated with severe pain. The success of knee rehabilitation following surgery depends largely on adequate pain control that permits early physical therapy. Postoperative modern analgesic recommendations specific to TKA propose either spinal block with intrathecal morphine (ITM) or a combination of general anesthesia with single shot femoral nerve block (SFNB). Femoral nerve block (FNB) too has proven analgesic advantages in TKA surgery. However, we do not know if the combination of the two analgesic techniques, ITM and peripheral nerve blocks (PNB), provides superior analgesia to ITM alone.\n\nThus, this study aims to determine whether ITM alone or its combination with PNB provides better analgesia for patients undergoing total knee arthroplasty (TKA).\n\nEligible patients undergoing unilateral TKA under spinal anesthesia consenting to a multimodal analgesic regimen inclusive of ITM, FNB, and SNB will be recruited. All patients will receive spinal with intrathecal morphine. Patients will be randomly assigned using a computer generated table of random numbers to receive either spinal with intrathecal morphine (morphine group), a combination of intrathecal morphine and femoral nerve block (morphine-femoral group), or a combination of intrathecal morphine and femoral nerve block as well as sciatic nerve block (morphine-femoral-sciatic group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III patients undergoing unilateral TKA under spinal anesthesia and nerve blocks\n* Ages 18-80\n* BMI ≤ 38 kg/m2\n\nExclusion Criteria:\n\n* BMI \\> 38 kg/m2\n* chronic pain disorders\n* Significant pre-existing neurological deficits or peripheral neuropathy affecting the lower extremity\n* abuse of drugs or alcohol\n* Contraindication to a component of multi-modal analgesia\n* Contraindication to spinal anesthesia or failure to institute spinal anesthesia after performing femoral and sciatic blocks\n* Bilateral TKA surgeries\n* History of significant psychiatric conditions that may affect patient assessment\n* Pregnancy\n* Moderate to severe obstructive sleep apnea.\n* Previous adverse reactions resulting from intrathecal opioids (respiratory depression, urinary retention, severe pruritis, severe nausea or vomiting, severe sedation)\n* inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT02135120', 'briefTitle': 'The Efficacy of Peripheral Nerve Blocks With Intrathecal Morphine in Improving Analgesia After Unilateral Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'American University of Beirut Medical Center'}, 'officialTitle': 'Do Peripheral Nerve Blocks When Used as Part of a Multimodal Regimen Inclusive on Intrathecal Morphine Improve Analgesia After Unilateral Total Knee Arthroplasty? A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'ANES.GK.09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine group', 'description': 'Patients will receive a combined spinal epidural anesthesia technique with intrathecal morphine', 'interventionNames': ['Drug: Combined spinal epidural anesthesia technique with intrathecal morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine-femoral group', 'description': 'Patients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block', 'interventionNames': ['Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine-femoral-sciatic group', 'description': 'Patients will receive a combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block', 'interventionNames': ['Drug: A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block']}], 'interventions': [{'name': 'Combined spinal epidural anesthesia technique with intrathecal morphine', 'type': 'DRUG', 'armGroupLabels': ['Morphine group']}, {'name': 'A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block', 'type': 'DRUG', 'armGroupLabels': ['Morphine-femoral group']}, {'name': 'A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block', 'type': 'DRUG', 'armGroupLabels': ['Morphine-femoral-sciatic group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'American University of Beirut Medical Center', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Ghassan E Kanazi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'American Univesity of Beirut Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'American University of Beirut Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chairman', 'investigatorFullName': 'Ghassan Kanazi', 'investigatorAffiliation': 'American University of Beirut Medical Center'}}}}