Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-02-26 @ 12:38 AM
Study NCT ID:
NCT02436694
Status:
UNKNOWN
Last Update Posted:
2015-11-26
First Post:
2015-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nerve Blocks With Dexamethasone and Local Anaesthetic to Improve Postoperative Analgesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}, {'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-11-25', 'studyFirstSubmitDate': '2015-04-01', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2015-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantification of Pain by VAS', 'timeFrame': '48 hours', 'description': 'Pain assessed by VAS'}], 'secondaryOutcomes': [{'measure': 'Morphine consumption in mg', 'timeFrame': '48 hours', 'description': 'Morphine consumption in PCA measured in mg'}, {'measure': 'Side-effects (numbness, paraesthesias, weakness, site infection, haematoma and falls)', 'timeFrame': '48 hours'}, {'measure': 'Complications from technique (Motor ou sensitive changes, infection, nausea)', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dexamethasone', 'Perineural'], 'conditions': ['Nerve Block']}, 'descriptionModule': {'briefSummary': 'Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.\n\nOutcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and falls).', 'detailedDescription': 'All blocks are performed using nerve stimulation technique. For the SSFNB, the paravascular approach will be used to identify the femoral nerve.15 A positive location is considered when quadriceps contraction (patellar elevation) is elicited with a current of 0.4 mA or less, and 30mL of ropivacaine 0.375%, with or without 4mg of dexamethasone are injected, according to the randomization.\n\nFor the SSSNB the anterior approach will be chosen.16 The common peroneal or the tibial nerves are identified, respectively by dorsiflexion or plantar flexion of the foot, with a current of 0.4 mA or less. Depending on the allocated group, 20mL of ropivacaine 0.2%, with or without 4mg of dexamethasone are then injected. Blocks success should be assessed by the absence of thermal sensitivity on the anterior region of the thigh and the dorsum of the foot 10 minutes after the block.\n\nThe participating anaesthesiologists may use the ultrasound for visual guidance but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.\n\nPatients will then have an intravenous induction to general anesthesia, being the maintenance assured with either Desflurane or Sevoflurane. Thirty minutes before the end of the procedure all patients are given paracetamol 1000mg and ketorolac 30mg. Total doses of intraoperative analgesics are recorded.\n\nBefore surgery all patients will be explained how to use the PCA, which is connected after arrival to the post-anesthesia unit (PACU). The PCA is programmed for 1mg bolus as required by the patient, with a lockout period of 7 minutes. In what concerns the remaining post-operative analgesia, both groups are prescribed paracetamol 1000mg q8h, diclofenac 50mg q12h, and as rescue strategy, tramadol 100mg q6h.\n\nThe demographic data as well as the information of the anesthetic form is recorded in an excel table. After surgery, at 8-12h, 24h and 48h (+/-2h) pain is evaluated using a standard 100mm VAS. Consumption of morphine and other rescue analgesia is recorded in the same time periods, as well as the complications and side-effects previously determined.\n\nThe primary outcome is pain assessed by VAS (1-100mm - continuous variable), measured ate 8-12h, 24h and 48h. Difference in mean values for both groups will be measured. Morphine consumption is measured in milligrams, and the mean consumption of both groups is analysed. Side-effects and complications will be reported and their incidence calculated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients admitted foi unilaterla total knee arthroplasty\n\nExclusion Criteria:\n\n* Refusal/Incapacity to give informed consent\n* Contra-indication to general anesthesia\n* Infection at needle insertion site\n* Coagulation disorders\n* Pre-existing neurologic disorders\n* Known allergy to any of the drugs from the protocol\n* ASA status \\>3\n* Weight\\<50kg\n* BMI\\>40\n* Inability to understand or use VAS pain score'}, 'identificationModule': {'nctId': 'NCT02436694', 'briefTitle': 'Nerve Blocks With Dexamethasone and Local Anaesthetic to Improve Postoperative Analgesia', 'organization': {'class': 'OTHER', 'fullName': 'Centro Hospitalar do Porto'}, 'officialTitle': 'Can the Association of Dexamethasone and Local Anaesthetic in a Single-shot Femoral and Sciatic Nerve Block Improve Analgesia Postoperatively in Patients Submitted to Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2014.236(174-DEFI/199-CES)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Local Anesthetic ropivacaíne', 'description': 'Femoral nerve block with ropivacaine 0.375% and sciatic nerve block with ropivacaine 0.2%', 'interventionNames': ['Drug: Local Anesthetic ropivacaíne']}, {'type': 'EXPERIMENTAL', 'label': 'Perineural Dexamethasone', 'description': 'Femoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone', 'interventionNames': ['Drug: Local Anesthetic ropivacaíne', 'Drug: Perineural Dexamethasone']}], 'interventions': [{'name': 'Local Anesthetic ropivacaíne', 'type': 'DRUG', 'otherNames': ['Nerve block with local anesthetic'], 'description': 'Femoral and sciatic nerve block with ropivacaíne', 'armGroupLabels': ['Local Anesthetic ropivacaíne', 'Perineural Dexamethasone']}, {'name': 'Perineural Dexamethasone', 'type': 'DRUG', 'otherNames': ['Nerve block with local anesthetic and dexamethasone'], 'description': 'Addition of perineural dexamethasone to local anesthetic for femoral and sciatic nerve block', 'armGroupLabels': ['Perineural Dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4099-001', 'city': 'Porto', 'state': 'Porto District', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Marta M Carvalho, MD', 'role': 'CONTACT', 'email': 'marta.monteiro.carvalho@gmail.com', 'phone': '00351912948973'}, {'name': 'Silvia AB Pinho, MD', 'role': 'CONTACT', 'email': 'silviaabpinho@gmail.com', 'phone': '00351914619787'}], 'facility': 'Centro Hospitalar do Porto', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}], 'centralContacts': [{'name': 'Marta M Carvalho, MD', 'role': 'CONTACT', 'email': 'marta.monteiro.carvalho@gmail.com', 'phone': '00351 912948973'}, {'name': 'Silvia AB Pinho, MD', 'role': 'CONTACT', 'email': 'silviaabpinho@gmail.com', 'phone': '00351914619787'}], 'overallOfficials': [{'name': 'Raul carvalho, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro Hospitalar do Porto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar do Porto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Marta Carvalho', 'investigatorAffiliation': 'Centro Hospitalar do Porto'}}}}