Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2026-02-20 @ 6:49 PM
Study NCT ID:
NCT02882035
Status:
COMPLETED
Last Update Posted:
2016-08-29
First Post:
2016-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Opioid Free Anesthesia: What About Patient Comfort?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-26', 'studyFirstSubmitDate': '2016-08-24', 'studyFirstSubmitQcDate': '2016-08-26', 'lastUpdatePostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'QoR-40', 'timeFrame': '24 hours post-operatively', 'description': 'Patient comfort was assessed via the QoR-40 questionnaire 24hours post-operatively.'}], 'secondaryOutcomes': [{'measure': 'Post-operative NRS', 'timeFrame': 'during 24 hours post-operative', 'description': 'Pain assessment via NRS'}, {'measure': 'Post-operative piritramide consumption', 'timeFrame': 'during the first 24 hours post-operative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pain', 'patient comfort'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': '66 female patients undergoing breast cancer surgery were randomized in the Jules Bordet Institute, the Belgian oncology institute. One group received an opioid anesthesia, the other group an opioid free one. The hypothesis of this study was that opioid free anesthesia improves the postoperative quality of recovery of anesthesia.', 'detailedDescription': 'Opioids used as part of balanced anesthesia have known undesired side effects such as: respiratory depression, post-operative nausea and vomiting, pruritus, difficulty voiding and ileus.\n\nThe purpose of this study was to determine whether opioid free anesthesia influences the quality of recovery. A multimodal approach combining ketamine, lidocaine and clonidine was used as an alternative for an opioid based anesthesia.\n\nThe hypothesis of this study was that patient comfort and satisfaction level after an opioid free anesthesia would be higher compared to after a more traditional opioid anesthesia.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Oncological patients undergoing a total mastectomy or lumpectomy associated with a total axillary dissection were screened.\n* Patients with an ASA physical status of II were included.\n* Knowledge of either French, English or Dutch was required.\n\nExclusion criteria were the following:\n\n* Allergy or contraindications to one of the study drugs, renal failure, hepatic failure, hyperthyroidism, AV block 2 or 3 or severe bradycardia, left ventricular failure, unstable blood pressure, epilepsy and psychiatric disturbance.'}, 'identificationModule': {'nctId': 'NCT02882035', 'briefTitle': 'Opioid Free Anesthesia: What About Patient Comfort?', 'organization': {'class': 'OTHER', 'fullName': 'Université Libre de Bruxelles'}, 'officialTitle': 'Opioid Free Anesthesia: What About Patient Comfort?', 'orgStudyIdInfo': {'id': 'CE2261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OFA (opioid free anesthesia)', 'description': 'All drugs were given IV. Induction in the opioid free group began with a loading dose of clonidine (0.2 mcg kg-1), a bolus of ketamine (0.3 mg kg -1) lidocaine (1.5 mg kg -1) and a bolus of propofol (2-3 mg kg -1).\n\nGeneral anesthesia was maintained with sevoflurane (MAC: 1) (adapted according to hemodynamic stability).\n\nUpon the incision, acetaminophen (1000 mg) and diclofenac (75 mg) were given in both groups. A bolus of ketamine (0.2mg kg -1) was given if necessary in the opioid free group (up to three bolus max. were permitted).\n\nA bolus of piritramide (0.03 mg kg -1) was administered upon subcutaneous closure.\n\nPostoperative pain was treated with IV acetaminophen (1000 mg) every 6 h for the first 24 hours and IV diclofenac (75 mg) every 12 h for the first 24 hours. Patients received a PCIA (patient-controlled intravenous analgesia) pump of piritramide.', 'interventionNames': ['Other: OFA']}, {'type': 'NO_INTERVENTION', 'label': 'OA (opioid anesthesia)', 'description': 'All drugs were given IV. Induction in the opioid group began with remifentanil TCI, a bolus of ketamine (0.3 mg kg -1) lidocaine (1.5 mg kg -1) and a bolus of propofol (2-3 mg kg -1).\n\nGeneral anesthesia was maintained with sevoflurane (MAC: 1). Upon the incision, acetaminophen (1000 mg) and diclofenac (75 mg) were given in both groups.\n\nA bolus of piritramide (0.03 mg kg -1) was administered upon subcutaneous closure.\n\nPostoperative pain was treated with IV acetaminophen (1000 mg) every 6 h for the first 24 hours and IV diclofenac (75 mg) every 12 h for the first 24 hours. Patients received a PCIA (patient-controlled intravenous analgesia) pump of piritramide.'}], 'interventions': [{'name': 'OFA', 'type': 'OTHER', 'armGroupLabels': ['OFA (opioid free anesthesia)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jules Bordet Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Sarah Saxena', 'investigatorAffiliation': 'Université Libre de Bruxelles'}}}}