Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-02 @ 1:09 PM
Study NCT ID:
NCT03198403
Status:
COMPLETED
Last Update Posted:
2017-09-29
First Post:
2017-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Pilot Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-28', 'studyFirstSubmitDate': '2017-06-20', 'studyFirstSubmitQcDate': '2017-06-23', 'lastUpdatePostDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with postoperative pain NRS', 'timeFrame': '0 - 60 minutes', 'description': 'Evaluated as the percentage of patients with postoperative pain NRS \\>3, dropping in pain score to NRS = or \\< 3 after the PPB'}], 'secondaryOutcomes': [{'measure': 'Percentage of patients having a femoral triangle block(FTB) reporting NRS > 3', 'timeFrame': 'Pain scores every 15 minutes (from end injection FTB to NRS>3 or 3 hours after full sensation of the leg)', 'description': 'Percentage of patients having a FTB, reporting postoperative pain NRS \\>3'}, {'measure': 'Onset time of PPB', 'timeFrame': 'NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)', 'description': 'Time from end of injection of PPB to NRS = or \\< 3'}, {'measure': 'Turn off time of spinal anesthesia', 'timeFrame': 'Time from arrival in PACU and during maximum 6 hours', 'description': 'Time from arrival in PACU to normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) on the lateral part of the thigh and lateral part of the lower leg'}, {'measure': 'Correlation between normal cutaneous sensation and developing of pain', 'timeFrame': 'From arrival in PACU and during maximum 6 hours', 'description': 'Correlation between normal cutaneous sensation (measured by a neuro-pen, sensation=point 2) and developing of pain (NRS\\>3)'}, {'measure': 'The effect of the PPB on cutaneous sensation', 'timeFrame': 'NRS every 5 minutes after PPB (From 0 - 60 minutes after PPB)', 'description': 'Tested on the lateral part of the lower leg'}, {'measure': 'The effect of the PPB on muscle strength of the foot', 'timeFrame': 'Baseline and 1 hour after PPB', 'description': 'Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Popliteal Plexus Block', 'Total Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effect of the Popliteal plexus block (PPB) on postoperative pain after total knee arthroplasty', 'detailedDescription': 'Cadaver dissection studies have shown a spread of dye to the popliteal fossa and colored the popliteal plexus by injecting in the distal part of the adductor Canal.\n\nThe popliteal plexus is formed by contribution from the tibial and the obturator nerves.\n\nInvestigators hypothesized that a PPB may reduce postoperative pain after total knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing total knee arthroplasty in spinal anesthesia\n* age \\> or = 18 years\n* American Society of Anesthesiologists (ASA) status I-III\n* Informed consent\n\nExclusion Criteria:\n\n* Patients unable to cooperate\n* Patients not able to speak Danish\n* Pregnancy\n* Contraindication towards ana Medical product used in the study\n* Preoperatively reduced sensation on the medial and lateral part of the lower leg\n* Patients with diabetic requiring Medical treatment\n* Preoperative daily intake of opioids'}, 'identificationModule': {'nctId': 'NCT03198403', 'briefTitle': 'The Effect of Popliteal Plexus Block on Pain After Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Silkeborg'}, 'officialTitle': 'The Effect of Popliteal Plexus Block on Postoperative Pain After Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2017-001644-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Popliteal plexus block', 'description': 'Patients with an FTB, reporting postoperative pain (NRS \\> 3) will have a popliteal plexus block', 'interventionNames': ['Drug: Bupivacaine-epinephrine']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention', 'description': 'Patients with postoperative pain NRS \\< or = 3'}], 'interventions': [{'name': 'Bupivacaine-epinephrine', 'type': 'DRUG', 'description': 'Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.', 'armGroupLabels': ['Popliteal plexus block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8600', 'city': 'Silkeborg', 'country': 'Denmark', 'facility': 'Silkeborg Regionalhospital', 'geoPoint': {'lat': 56.1697, 'lon': 9.54508}}], 'overallOfficials': [{'name': 'Charlotte Runge, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Aarhus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regionshospitalet Silkeborg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant anesthetist, Principal investigator', 'investigatorFullName': 'Charlotte Runge', 'investigatorAffiliation': 'Regionshospitalet Silkeborg'}}}}