Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-27 @ 6:06 AM
Study NCT ID:
NCT05072704
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2021-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Free Anesthesia in Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017409', 'term': 'Sufentanil'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2021-09-17', 'studyFirstSubmitQcDate': '2021-09-28', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative analgesia, defined by the oxycodone consumption in the first 24 hours post-surgery', 'timeFrame': '24 hours', 'description': 'Postoperative cumulated dose of oxycodone in oral morphine equivalent (mg)'}], 'secondaryOutcomes': [{'measure': 'Analgesia in post-anesthesia care unit (PACU)', 'timeFrame': '6 hours', 'description': 'Total amount of oxycodone (mg) administered in PACU'}, {'measure': 'Postoperative pain at rest', 'timeFrame': '24 hours', 'description': 'Postoperative pain at rest (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)'}, {'measure': 'Postoperative pain at walk', 'timeFrame': '24 hours', 'description': 'Postoperative pain at mobilization (numeric rating scale ranging from 0 to 10: 0= no pain; 10= worst imaginable pain)'}, {'measure': 'Side effects associated with opioids', 'timeFrame': '24 hours', 'description': 'Complications due to oxycodone (postoperative nausea and vomiting, drowsiness, acute urinary retention, pruritus, disorientation)'}, {'measure': 'Side effects associated with dexmedetomidine', 'timeFrame': '24 hours', 'description': 'Complications due to dexmedetomidine (bradycardia defined by HR\\<50 bpm or requiring the use of atropine; hypotension defined by SBP\\<90 mmHg or requiring the use of vasoconstrictors; hypertension defined by SBP\\>160 mmHg).'}, {'measure': 'Outpatient care failure', 'timeFrame': '24 hours', 'description': 'Unplanned hospitalizations'}, {'measure': 'Length of stay in post-anesthesia care unit (PACU)', 'timeFrame': '6 hours', 'description': 'Duration of PACU stay (min)'}, {'measure': 'Time to recover the ability to walk', 'timeFrame': '12 hours', 'description': 'Duration for recovery the ability to walk (min)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hip arthroplasty', 'Opioid free anesthesia', 'Dexmedetomidine', 'Postoperative analgesia'], 'conditions': ['Primary Total Hip Arthroplasty']}, 'descriptionModule': {'briefSummary': 'Total hip arthroplasty (THA) is one of the most common orthopedic surgical procedure and is associated with severe pain in the immediate postoperative period, thus limiting early recovery.\n\nPostoperative pain management in THA requires multimodal analgesia, combining drugs and injection of a local anesthetic (LA). But, the best anesthesia strategy to provide optimal postoperative analgesia in THA remains controversial. Opioid free anesthesia could limit the episodes of hyperalgesia as well as tolerance and addiction to opioids.\n\nThe hypothesis of this study is that an opioid free anesthesia using dexmedetomidine could improve analgesia after THA.\n\nThe main objective of this monocenter, prospective, randomized, triple-blind, controlled trial is to assess the interest of opioid free anesthesia using dexmedetomidine on morphine consumption after THA.', 'detailedDescription': "In the pre-anaesthesia room, after the implementation of classical monitoring and a peripheral venous catheter, all patients will receive an antibioprophylaxis according to SFAR (French Society of Anesthesia \\& Intensive Care Medecine) recommendations and injection of 10 mg of IV dexamethasone.\n\nThe patients will be then randomized in 2 groups:\n\nControl group:\n\n* Pre-operative normal saline infusion 100 ml over 30 minutes\n* Injection of sufentanil 10 µg in normal saline 2 ml on induction of anesthesia\n\nIf needed after incision :\n\n* Per-operative normal saline infusion 100 ml\n* Per-operative injection of sufentanil 5 µg in normal saline 1 ml\n\nOFA group (experimental group):\n\n* Pre-operative dexmedetomidine infusion 1 µg/kg in normal saline 100 ml over 30 minutes\n* Injection of normal saline 2 ml on induction of anesthesia\n\nIf needed after incision :\n\n* Per-operative dexmedetomidine infusion 0.4 µg/kg in normal saline 100 ml\n* Per-operative injection of normal saline 1 ml\n\nIn the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg) + propofol (3 mg/kg) +/- cisatracurium (0.1 mg/kg) for the introduction of laryngeal mask airway. Anesthesia will be maintained with propofol.\n\nPostoperative analgesia protocol :\n\n* Multimodal analgesia will be instituted during surgery by the administration of paracetamol (1 g), nefopam (20 mg) and ketoprofen (100 mg) and the infiltration of the surgical wound with 100 ml of ropivacaine 0.2%.\n* In post-anesthesia care unit (PACU): oxycodone titration if NRS (pain score) \\>3 according to the centre's usual care.\n* In ward and at home: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen (400 mg, 3 times a day); oxycodone (10 mg, lockout interval: 4 h) if NRS (pain score) \\>3."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older,\n* Undergoing outpatient primary total hip arthroplasty under general anesthesia with laryngeal mask,\n* Consent for participation,\n* Affiliation to a social security system\n\nExclusion Criteria:\n\n* Heart rate \\< 60 bpm\n* Chronic pain syndrome requiring preoperative morphine use (class 3)\n* Contraindication for: paracetamol, ketoprofen, nefopam, oxycodone, propofol, ketamine, cisatracurium, sufentanyl, ropivacaine.\n* Contraindication for dexmedetomidine: hypersensitivity to the active substance or to any of the excipients, advanced cardiac block (grade 2 or 3) unless paced ; uncontrolled hypotension ; acute cerebrovascular conditions\n* Contraindication to laryngeal mask : old insulin-dependent diabetes, gastro-oesophageal reflux, morbid obesity (defined by BMI \\> 35)\n* Pregnant or breastfeeding women\n* Women of child bearing potential without contraception (any contraceptive method used regularly and appropriately with a low failure rate: \\<1% per year),\n* A mental or linguistic inability to understand the study,\n* Patient under protection of the adults (guardianship, curators or safeguard of justice),\n* Patient included or planning to be included in another clinical trial relating to medications'}, 'identificationModule': {'nctId': 'NCT05072704', 'acronym': 'OFATHA', 'briefTitle': 'Opioid Free Anesthesia in Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'CMC Ambroise Paré'}, 'officialTitle': 'Opioid Free Anesthesia in Total Hip Arthroplasty. A Randomized, Controlled and Triple-blind Clinical Trial', 'orgStudyIdInfo': {'id': '2021/04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Sufentanil IV injection', 'interventionNames': ['Drug: Sufentanil']}, {'type': 'EXPERIMENTAL', 'label': 'OFA group', 'description': 'Dexmedetomidine IV infusion', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Sufentanil', 'type': 'DRUG', 'description': 'Pre-operative injection of sufentanil 10µg in 2ml of normal saline on induction of anesthesia + per-operative injection of sufentanil 5µg in 1ml of normal saline during the surgery if needed.', 'armGroupLabels': ['Control group']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'Pre-operative infusion of dexmedetomidine 1µg/kg in 100ml of normal saline before surgery + per-operative infusion of dexmedetomidine 0.4 µg/kg in 100ml of normal saline during the surgery if needed.', 'armGroupLabels': ['OFA group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31036', 'city': 'Toulouse', 'state': 'Haute-Garonne', 'country': 'France', 'facility': 'Clinique Médipôle Garonne', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMC Ambroise Paré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}