Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-03-07 @ 1:57 PM
Study NCT ID:
NCT03922412
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2019-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery
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', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2019-04-11', 'studyFirstSubmitQcDate': '2019-04-18', 'lastUpdatePostDateStruct': {'date': '2023-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of steps walking ability assessed by GAITRITE Test', 'timeFrame': '6 hours after ALR', 'description': 'Comparison of the deambulation assessed by GAITRITE test (walking test) between patient who received plantar block and patient who received sciatic popliteal block'}], 'secondaryOutcomes': [{'measure': 'Quantity of postoperative rescue analgesics taken', 'timeFrame': 'up to 3 days after surgery', 'description': 'Comparison of the postoperative pain assessed by the Quantity of post-operative rescue analgesics between each group of patients'}, {'measure': 'Assessment of the quality of the sensory blocks', 'timeFrame': 'during the surgery', 'description': 'Comparison of the sensory territories of anesthesia using cold between each group'}, {'measure': 'Assessment of the patient hospitalisation duration', 'timeFrame': 'up to 3 days after surgery', 'description': 'Comparison of the duration of hospitalization between each group'}, {'measure': 'Assessment of overall patient satisfaction assessed by the scale EVAN Loco regional', 'timeFrame': 'up to 3 days after surgery', 'description': 'Comparison of overall patient satisfaction between each group'}, {'measure': 'Assessment of sleep quality Assessment of patient sleep quality', 'timeFrame': 'up to 3 days after surgery', 'description': 'Comparison of patient sleep quality assessed by the somnifer consumption during the postoperative hospitalization between each group'}, {'measure': 'Efficacity of patient walking ability', 'timeFrame': 'up to 3 days after surgery', 'description': 'Comparison of the deambulation assessed by acetemeter between patient who received plantar block and patient who received sciatic popliteal block'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia', 'plantar Block'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.\n\nSciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.\n\nPlantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.\n\nThis study aims to determine the quality of deambulation following hallux valgus surgery.\n\nBlock quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.\n\nPatients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.\n\nConsenting patients will be randomized the day of surgery to one of those two groups :\n\n1. Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).\n2. Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)\n\nAll patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.\n\nDuring PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.\n\nTemporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital.\n\nDeambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.\n\nPain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.', 'detailedDescription': 'Hallux valgus surgery is known as a painful surgery. Qualitative pain management is the key to successful early recovery and rehabilitation.\n\nSciatic popliteal nerve block is widely used despite the risk of falling due to prolonged motor blockade.\n\nPlantar block combined with distal peroneal block may be a better analgesic option in order to provide fast track rehabilitation.\n\nThis study aims to determine the quality of deambulation following hallux valgus surgery.\n\nBlock quality, post operative pain, patient satisfaction and length of hospital stay will be compared in this study.\n\nPatients scheduled for ambulatory (hallux valgus) surgery under regional anaesthesia alone (without general anesthesia) will be recruited.\n\nConsenting patients will be randomized the day of surgery to one of those two groups :\n\n1. Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).\n2. Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)\n\nAll patients will benefit from post operative analgesia including paracetamol, nonsteroidal antiinflammatory drugs intravenously.\n\nDuring PACU stay, pain will be assessed using the VAS (visual analogue scale) score, and analgesic IV consumption.\n\nTemporospatial gait analysis will be assessed with a GAITRITE system before the patient leave the hospital (6 hours after ALR).\n\nDeambulation and walking ability will be evaluated at home postoperatively to day 3 using an acetimetry bracelet.\n\nPain, postoperative analgesic requirement, sleep quality and overall patient satisfaction (EVAN-LR) will also be assessed during the first 3 postoperative days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 75 years old\n* patient covered by social health insurance\n* have signed written informed consent\n* scheduled for hallux valgus ambulatory surgery\n\nExclusion Criteria:\n\n* protected patients or patients incapable of giving written informed consent\n* pregnant or breastfeeding woman\n* vulnerable adult\n* inability to participate in pain scoring scales\n* severe coagulopathy\n* allergy or contraindications to study drugs\n* preoperative gait disorders\n* chronic kidney disease with glomerular filtration rate (GFR) ≤ 50 ml/min (estimated by the Cockcroft and Gault formula)\n* severe chronic liver disease\n* chronic pain (treated by non steroidal anti inflammatory drugs, opioids, neuroleptic drugs, antidepressant or anticonvulsants)\n* peripheral neuropathy\n* intervention under general anesthesia'}, 'identificationModule': {'nctId': 'NCT03922412', 'acronym': 'Plantar-block', 'briefTitle': 'Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Plantar Compartment Block Versus Sciatic Block in Hallux Valgus Ambulatory Surgery : a Prospective, Randomised, Double Blind Study', 'orgStudyIdInfo': {'id': 'RECHMPL18_0489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'plantar block', 'description': 'Short lasting sciatic nerve block (mepivacaine 1% 200mg) and long lasting plantar block (ropivacaine 0,5% 25mg + 2mg dexamethasone) with distal deep peroneal block (ropivacaine 0,5% 2ml).', 'interventionNames': ['Procedure: PLANTAR BLOCK']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sciatic popliteal block', 'description': 'Long lasting sciatic nerve block (ropivacaine 0,5% 100mg + 2mg dexamethasone)', 'interventionNames': ['Procedure: Sciatic popliteal block']}], 'interventions': [{'name': 'PLANTAR BLOCK', 'type': 'PROCEDURE', 'description': '1. Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of mepivacain 1% (200mg)\n2. Plantar block 10 minutes later : patient in supine position. Medial midfoot injection of 5 ml of the mixture labelled " BLOC PLANTAIRE " containing 5 ml of Ropivacaine 0,5% (25mg) with 0,5 ml dexaméthasone (2mg)\n3. Distal deep fibular block : patient in supine position, injection around the dorsal foot artery of 2 ml of the mixture labelled " BLOC FIBULAIRE " containing 2 ml of Ropivacaine 0,5% (10mg).', 'armGroupLabels': ['plantar block']}, {'name': 'Sciatic popliteal block', 'type': 'PROCEDURE', 'description': '1-Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled " BLOC POPLITE " containing 20 ml of ropivacaine 0,5% (100mg) with 2mg (0,5 ml) of dexamethasone', 'armGroupLabels': ['Sciatic popliteal block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34000', 'city': 'Montpellier', 'country': 'France', 'facility': 'UH Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}