Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT04890418
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2020-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007649', 'term': 'Ketamine'}], 'ancestors': [{'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The local pharmacy department is in charge of unmasking the drug.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2020-03-03', 'studyFirstSubmitQcDate': '2021-05-17', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of severe postoperative rebound pain', 'timeFrame': 'from surgery to 30 days post operation', 'description': 'Rebound pain after PNB is defined as a Numerical rating Scale of 7 or more.'}], 'secondaryOutcomes': [{'measure': 'To measure the impact of ketamine on the level of "rebound pain" in patients with central sensitivity using the Numerical Rating Scale', 'timeFrame': 'from surgery to 30 days postoperatively', 'description': 'Central sensitivity analyzed by a questionnaire and by Numerical Rating Scale'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgery']}, 'descriptionModule': {'briefSummary': 'Risk factors and Prevention of severe Pain upon cessation of a peripheral nerve block. A prospective randomized study in ambulatory patients undergoing upper limb bone surgery under single shot axillary plexus block.', 'detailedDescription': "Pain in the course of upper limb bone surgery is a major source of discomfort for patients during postoperative time.\n\nSevere post-operative pain is a risk factor for chronic pain. Use of a well-known molecule, regularly used in anesthesiology. Prospective double-blind study on 120 patients. Pain rebound upon awakening of the axillary plexus during upper limb bone surgery is a frequent phenomenon in post-operative follow-up of patients.\n\nThe anti-hyperalgesic properties of ketamine could be a benefit against this effect.\n\nNo studies have combined intravenous ketamine with localoregional anesthesia to reduce pain upon its release.\n\nThis may improve patients' post-operative comfort. The patients will be randomized in 2 groups and allocated to receive (slow intravenous injection) either 0.3 mg/kg intravenous ketamine diluted into 10mL saline or 10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any ambulatory upper limb bone surgery carried out under axillary PNB\n\nExclusion Criteria:\n\n* Refusal to participate\n* Contraindication to the use of ketamine\n* Contraindication to regular use of postoperative analgesics like non-steroidal anti-inflammatory drugs and paracetamol\n* Pregnant woman\n* Diabetic patient\n* Vascular patient\n* Cognitive disorders\n* Inability to answer perioperative questionnaires (language problem)'}, 'identificationModule': {'nctId': 'NCT04890418', 'acronym': 'PRPK', 'briefTitle': 'Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block', 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': 'Risk Factors and Prevention of Severe Pain Upon Cessation of a Peripheral Nerve Block. A Prospective Randomized Study in Ambulatory Patients Undergoing Upper Limb Bone Surgery Under Single Shot Axillary Plexus Block', 'orgStudyIdInfo': {'id': '2019/05JUL/303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Study drug', 'description': '0.3 mg/kg intravenous ketamine diluted into 10mL saline after the realization of peripheral nerve block (PNB), before tourniquet set up and beginning of surgery', 'interventionNames': ['Drug: Ketalar, 5 mg/mL Injectable Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10 mL 0.9% saline after the realization of PNB, before tourniquet set up and beginning of surgery', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Ketalar, 5 mg/mL Injectable Solution', 'type': 'DRUG', 'otherNames': ['Active comparator'], 'description': 'The patients will receive (slow intravenous injection) 0.3 mg/kg intravenous ketamine diluted by the pharmacy department into 10mL saline after the realization of PNB but before tourniquet set up and before start of surgery.', 'armGroupLabels': ['Study drug']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Placebo comparator'], 'description': 'The patients will receive 10 mL of 0.9% saline. This injection is also performed after the realization of PNB but before tourniquet set up and before start of surgery.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': "Patricia LAVAND'HOMME, PhD", 'role': 'CONTACT', 'email': 'patricia.lavandhomme@uclouvain.be', 'phone': '3227641897'}, {'name': 'Nassim TOUIL, MD', 'role': 'CONTACT', 'email': 'nassim.touil@uclouvain.be', 'phone': '3227641888'}], 'facility': 'Cliniques Universitaires Saint-Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': "Patricia Lavand'homme", 'role': 'CONTACT', 'email': 'patricia.lavandhomme@uclouvain.be', 'phone': '+3224741888'}, {'name': 'Nassim Touil', 'role': 'CONTACT', 'email': 'nassim.touil@uclouvain.be', 'phone': '+3224741888'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}