Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-25 @ 2:05 PM
Study NCT ID:
NCT01544959
Status:
COMPLETED
Last Update Posted:
2018-10-24
First Post:
2010-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postoperative Analgesia Impact of Narcotic Free Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D020250', 'term': 'Postoperative Nausea and Vomiting'}, {'id': 'D006930', 'term': 'Hyperalgesia'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D009325', 'term': 'Nausea'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D014839', 'term': 'Vomiting'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000319', 'term': 'Adrenergic beta-Antagonists'}, {'id': 'C036604', 'term': 'esmolol'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D018674', 'term': 'Adrenergic Antagonists'}, {'id': 'D018663', 'term': 'Adrenergic Agents'}, {'id': 'D018377', 'term': 'Neurotransmitter Agents'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2010-09-09', 'studyFirstSubmitQcDate': '2012-03-05', 'lastUpdatePostDateStruct': {'date': '2018-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative consumption of narcotic in recovery room', 'timeFrame': 'Immediately after surgery'}], 'secondaryOutcomes': [{'measure': 'Pain level in recovery room', 'timeFrame': 'immediately after surgery'}, {'measure': 'Occurence of nausea and vomiting in the recovery room', 'timeFrame': 'immediately after surgery'}, {'measure': 'Time spent in recovery room', 'timeFrame': 'immediately after surgery'}, {'measure': 'Chronic post-surgical pain', 'timeFrame': '3 and 6 months'}, {'measure': 'Reccurence of breast cancer', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Narcotic', 'Opioid', 'betablocking drug', 'postoperative pain', 'postoperative nausea and vomiting', 'breast cancer', 'hyperalgesia', 'cancer recurrence', 'anesthesia', 'mastectomy', 'chronic postsurgical pain syndrome', 'acute postoperative pain', 'postmastectomy pain syndrome', 'pain', 'ambulatory surgery'], 'conditions': ['Pain, Postoperative', 'Breast Cancer', 'Postoperative Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'The first hypothesis of the study is that substituting fentanyl by esmolol and metoprolol during general anesthesia for patients undergoing mastectomy will result in less pain and less narcotic consumption in the recovery room. The investigators will also verify the impact of that substitution on nausea and vomiting, on the time spent in the recovery room and on chronic postsurgical pain (3 and 6 months).\n\nFinally, the investigators will see the impact on breast cancer recurrence 5 years after the surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Woman\n* 18 to 65 years old\n* ASA 1 or 2\n* First breast surgery\n* Unilateral breast cancer\n* Partial mastectomy or radical modified mastectomy ± axillary dissection\n\nExclusion Criteria:\n\n* Allergy or contrindication to any medication figuring in the protocol or to Aspirin\n* Patient taking betablocking drug drug or lanoxin or calcic channels blocking drug\n* Narcotic consumption in the past month of 10 mg/day of morphine equivalent\n* Chronic pain\n* Moderate to severe asthma\n* BMI of more than 40\n* Diabetes\n* Chronic renal or hepatic faiure\n* Heart failure\n* Anticipated difficult airway\n* High grade heart block or bifascicular block\n* Mental retardation'}, 'identificationModule': {'nctId': 'NCT01544959', 'acronym': 'PAINFree', 'briefTitle': 'Postoperative Analgesia Impact of Narcotic Free Anesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Université de Sherbrooke'}, 'officialTitle': 'The Impact on Postoperative Pain of Substituting Opioids by Beta Blockers for Peroperative Hemodynamic Control in Patients Undergoing Mastectomy', 'orgStudyIdInfo': {'id': 'CRC-09-174'}, 'secondaryIdInfos': [{'id': 'CAS-008-2010', 'type': 'OTHER_GRANT', 'domain': 'CAS/Vitaid Award'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'fentanyl', 'interventionNames': ['Drug: fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'beta-blocker', 'description': 'Instead of narcotics (fentanyl), esmolol and lopressor are being used for hemodynamic control', 'interventionNames': ['Drug: beta-blocker (esmolol, metropolol)']}], 'interventions': [{'name': 'fentanyl', 'type': 'DRUG', 'description': 'Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.', 'armGroupLabels': ['fentanyl']}, {'name': 'beta-blocker (esmolol, metropolol)', 'type': 'DRUG', 'description': 'esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.', 'armGroupLabels': ['beta-blocker']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'J1H 5N4', 'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}], 'overallOfficials': [{'name': 'Etienne de Medicis, MD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche du Centre hospitalier universitaire de Sherbrooke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Université de Sherbrooke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Etienne de Medicis', 'investigatorAffiliation': 'Université de Sherbrooke'}}}}