Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-07 @ 9:58 PM
Study NCT ID:
NCT03202134
Status:
COMPLETED
Last Update Posted:
2021-02-23
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jan.mulier@azsintjan.be', 'phone': '003250452490', 'title': 'Jan Mulier', 'organization': 'AZSintJanAV'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 month', 'description': 'using the definition of clinical trials for death and serious adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 9, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 67, 'seriousNumAtRisk': 149, 'deathsNumAffected': 0, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Post operative nausea and vomiting', 'notes': 'PONV: Minor complications graded by CLAVIEN and DINDOO as score 1', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 67, 'numAffected': 67}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Revision surgery', 'notes': 'Revision surgery for problem of vascularization, hematoma or other surgical reason.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With One or More Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'OG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'One month postoperative', 'description': 'number of minor and major complications (CLAVIEN) (DINDOO)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Post Operative Nausea or Vomiting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching opioid free anesthesia (OFA): Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'OG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'opioid anesthesia (OA) was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 hours postoperative', 'description': 'number of patients having Post operative nausea or vomiting (PONV)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain: Visual Analog Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'OG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.87', 'spread': '0.65', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours postoperative', 'description': 'postoperative Pain measured by visual analog scale: 0: no pain. 10 max pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Morphine Used', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'OG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.95', 'spread': '0.84', 'groupId': 'OG000'}, {'value': '4.94', 'spread': '0.54', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours postoperative', 'description': 'morphine consumed in mg', 'unitOfMeasure': 'milligram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Skin Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'OG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.04', 'spread': '0.25', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '24 hours post operative', 'description': 'temperature difference between free flap skin and central patient skin', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'OG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.82', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '7.52', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to two weeks', 'description': 'length of hospital stay in days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'FG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Opioid Free Anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.\n\nopioid free anesthesia: general anesthesia blocking reflexes without using an opioid'}, {'id': 'BG001', 'title': 'Opioid Anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '53.9', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '50.3', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Sex:Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'history of nausea after anesthesia', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '149', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-10-15', 'size': 113899, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-03-20T13:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 204}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-04', 'studyFirstSubmitDate': '2017-06-26', 'resultsFirstSubmitDate': '2019-12-10', 'studyFirstSubmitQcDate': '2017-06-26', 'lastUpdatePostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-04', 'studyFirstPostDateStruct': {'date': '2017-06-28', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With One or More Complications', 'timeFrame': 'One month postoperative', 'description': 'number of minor and major complications (CLAVIEN) (DINDOO)'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Post Operative Nausea or Vomiting', 'timeFrame': '24 hours postoperative', 'description': 'number of patients having Post operative nausea or vomiting (PONV)'}, {'measure': 'Postoperative Pain: Visual Analog Scale', 'timeFrame': '24 hours postoperative', 'description': 'postoperative Pain measured by visual analog scale: 0: no pain. 10 max pain'}, {'measure': 'Morphine Used', 'timeFrame': '24 hours postoperative', 'description': 'morphine consumed in mg'}, {'measure': 'Skin Temperature', 'timeFrame': '24 hours post operative', 'description': 'temperature difference between free flap skin and central patient skin'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'up to two weeks', 'description': 'length of hospital stay in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major and Minor Surgical Complications']}, 'descriptionModule': {'briefSummary': 'The Deep Inferior Epigastric Perforator free flap (DIEPflap) involves the transfer of abdominal tissue to the breast using microsurgery. Flap failure is rare today, but is devastating.\n\nBlood flow in a DIEPflap decreases during the first hours. Many anesthetic factors like low cardiac output, hypothermia and surgical stress cause vasoconstriction or thrombosis.\n\nA stable anesthesia during these long procedures improves flap perfusion. Postoperative nausea and vomiting (PONV) is frequent and might have an impact.\n\nOpioid free anesthesia (OFA) reduces PONV. The anti-inflammatory and vasodilator effects of the drugs dexmedetomidine and lidocaine might improve free flap perfusion.\n\nThe primary outcome counted all complications. The secondary outcomes were PONV, pain, opioid consumption, skin flap temperature and length of hospital stay.\n\nPatients get according to attending anesthesiologist an opioid or opioid free anesthesia without any randomization but based on availability of competence.', 'detailedDescription': 'The investigators included all patients in the hospital database.belgium who underwent DIEPflap surgery between Jan 2014 and April 2019. All patients entering the hospital provided consent to allow retrospective data analysis without patient identification.\n\nBecause patient assignment to an operating day was determined without knowing who would perform the anesthesia on a few exceptions, the choice of opioid free anesthesia (OFA) or opioid anesthesia (OA) in most cases was random. Patients were classified as receiving OFA when no opioids were given pre- or intra- operatively until wound closure. Opioids given after wound closure were counted as post-operative opioids. Patients who received a lower dose of intra-operative opioids by using additives were still classified as OA. Post-operative opioid free analgesia was classified as receiving no opioids after wound closure until discharge from hospital in patients not receiving medium- or long-acting opioids, pre- or intra-operatively.\n\nThe method of reaching OFA remained stable since 2014. Dexmedetomidine was given in a first loading dose of 0.3 mcg/kg 15 minutes before induction, a second loading dose of 0.1 mcg/kg at induction followed by an infusion of 0.1 mcg/kg/h for maintenance. Lidocaine is given as a loading dose of 1 mg/kg at induction followed by 1 mg/kg/h for maintenance. A Ketamine loading dose of 0.1 mg/kg is given at induction with an extra bolus of 0.7 mg/kg (or max 50 mg) before incision followed by an infusion of 0.1mg/kg/h.\n\nPost-operative analgesia was further improved by continuing very low doses of dexmedetomidine (0.05 mcg/kg/h), ketamine (0.05 mg/kg/h), and lidocaine (0.5 mg/kg/h) for the first hours (maximum 5 hours) with the possibility of giving a bolus of 10 mg lidocaine, 1 mg ketamine and 1 mcg dexmedetomidine every 15 minutes.\n\nOA was induced with sufentanil (0.1 - 0.3 mcg/kg) and continued with extra boli (0.1 - 0.2 mcg/kg) or a continuous infusion of remifentanil (0.20 - 0.35 mcg/kg/h). Since 2014 more and more additives like clonidine, dexmedetomidine, ketamine and lidocaine were given as a single additive at the induction to reduce the total dose of intraoperative opioid use. Nevertheless these patients were still counted as OA.\n\nAll patients getting OFA got a strict goal directed fluid therapy with an average amount of fluids between 600 and 1200 ml. Patients on OA got a more liberal fluid therapy resulting in total amounts between 3000 and 5000 ml. For each patient the total amount of fluids given intra operative and the duration of the surgical procedure is calculated.\n\nFollowing demographic data was retrieved: age, body mass index (BMI), American society of anesthesiology (ASA) score, incidence of hypertension, smoking or history of recent smoking, motion sickness or previous PONV. A bilateral DIEPflap is noted as bilat versus unilat and depending on the use of opioids postoperative an Apfel score is calculated. The number of anti emetic drugs given before any PONV took place and the number given after PONV is calculated, the incidence of nausea and the incidence of vomiting is measured. The maximum visual analog score (VAS) during the first 24 hours and the total equivalent dose of morphine used in the first 24 hours is measured.\n\nPostoperative flap skin temperature was measured every hour in the first 24 hours and compared to a reference skin temperature close by.\n\nPerioperative complications during the first post-operative month were graded according to a score (CLAVIEN), (DINDOO).\n\nDIEPflap failure was defined as the need for a revision procedure that fails in preserving the flap and requires a new or other flap procedure.\n\nThe investigators calculated length of hospital stay (LOS) as the total number of nights in hospital after surgery.\n\nThe investigators retrieved all measured factors potentially related to complications of grade I to grade V or healthcare utilization outcomes from the database and medical records. Post-operative opioids were defined as the total dose of opioids used during the first 24 hours post-operatively, calculated as iv morphine equivalents. The following were considered equivalent to 1 mg iv morphine: 1 mg iv or subcutaneous piritramide, 10 mg iv tramadol, or 2 mg sublingual oxycodone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'woman who are admitted for breast reconstruction using the diepflap (free flap)', 'genderDescription': 'breast reconstructive surgery is included', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: DIEPflap unilat or bilat woman between 18 and 60 years old-\n\nExclusion Criteria: none\n\n* allergy to any of the drugs used in anesthesia'}, 'identificationModule': {'nctId': 'NCT03202134', 'acronym': 'DIEPflap', 'briefTitle': 'Impact of Opioid Free Anesthesia on Outcome After DIEPflap Surgery', 'organization': {'class': 'OTHER', 'fullName': 'AZ Sint-Jan AV'}, 'officialTitle': 'Impact of Opioid Free Anesthesia on the Complications After DIEPflap Surgery: A Retrospective Observational Cohort Study.', 'orgStudyIdInfo': {'id': '2019OSOFADIEPFLAP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'opioid free anesthesia (OFA)', 'description': 'The method of reaching OFA: Dexmedetomidine was given in a first loading dose 15 minutes before induction, a second loading dose at induction followed by an infusion for maintenance. Lidocaine is given as a loading dose at induction followed by infusion for maintenance. A Ketamine loading dose is given at induction with an extra bolus before incision followed by an infusion.', 'interventionNames': ['Other: opioid free anesthesia']}, {'label': 'opioid anesthesia (OA)', 'description': 'OA was induced with sufentanil and continued with extra boli or a continuous infusion of remifentanil.'}], 'interventions': [{'name': 'opioid free anesthesia', 'type': 'OTHER', 'description': 'general anesthesia blocking reflexes without using an opioid', 'armGroupLabels': ['opioid free anesthesia (OFA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Bruges', 'country': 'Belgium', 'facility': 'Azsintjan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}], 'overallOfficials': [{'name': 'Jan Paul Mulier', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AZSint Jan AV'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chairman dep anesthesiology & Reanimation', 'investigatorFullName': 'Jan Mulier', 'investigatorAffiliation': 'AZ Sint-Jan AV'}}}}