Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2026-02-25 @ 8:30 PM
Study NCT ID:
NCT03908060
Status:
UNKNOWN
Last Update Posted:
2022-11-02
First Post:
2019-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008691', 'term': 'Methadone'}, {'id': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Randomisation and study medication will be handled by the hospital pharmacy. All research team members, caregiving clinicians and enrolled patients will be blinded to the study allocation arms and the randomisation list will be concealed until all statistical analyses are made.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 126}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-01', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2022-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption at 24 hours after extubation (cumulative opioid consumption)', 'timeFrame': '24 hours', 'description': 'cumulative opioid consumption in oral morphine equivalents'}, {'measure': 'Opioid consumption at 6 hours after extubation (cumulative opioid consumption)', 'timeFrame': '6 hours', 'description': 'cumulative opioid consumption in oral morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Pain intensity (NRS, 0-10) at rest and coughing', 'timeFrame': '0-48 hours after extubation', 'description': 'Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Postoperative side effects/ adverse events (nausea and vomiting, sedation, hypoventilation, and hypoxemia)', 'timeFrame': '0-72 hours after extubation', 'description': 'Number of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '25837528', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Marymont JH, Shear T, Parikh KN, Patel SS, Gupta DK. Intraoperative Methadone for the Prevention of Postoperative Pain: A Randomized, Double-blinded Clinical Trial in Cardiac Surgical Patients. Anesthesiology. 2015 May;122(5):1112-22. doi: 10.1097/ALN.0000000000000633.'}, {'pmid': '28418966', 'type': 'BACKGROUND', 'citation': 'Murphy GS, Szokol JW, Avram MJ, Greenberg SB, Shear TD, Deshur MA, Vender JS, Benson J, Newmark RL. Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Posterior Spinal Fusion Surgery: A Randomized, Double-blinded, Controlled Trial. Anesthesiology. 2017 May;126(5):822-833. doi: 10.1097/ALN.0000000000001609.'}, {'pmid': '20418538', 'type': 'BACKGROUND', 'citation': 'Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.'}, {'pmid': '2039637', 'type': 'BACKGROUND', 'citation': 'Richlin DM, Reuben SS. Postoperative pain control with methadone following lower abdominal surgery. J Clin Anesth. 1991 Mar-Apr;3(2):112-6. doi: 10.1016/0952-8180(91)90007-a.'}, {'pmid': '1609941', 'type': 'BACKGROUND', 'citation': 'Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51. doi: 10.1177/0310057X9202000109.'}, {'pmid': '37638083', 'type': 'DERIVED', 'citation': 'Friesgaard KD, Brix LD, Kristensen CB, Rian O, Nikolajsen L. Clinical effectiveness and safety of intraoperative methadone in patients undergoing laparoscopic hysterectomy: a randomised, blinded clinical trial. BJA Open. 2023 Aug 5;7:100219. doi: 10.1016/j.bjao.2023.100219. eCollection 2023 Sep.'}]}, 'descriptionModule': {'briefSummary': 'The role of a single-dose of intraoperative methadone on postoperative pain and opioid consumption in patients undergoing hysterectomy remains scarcely explored. A prospective double-blind, randomised controlled trial investigating the effect of a single-dose of intraoperative methadone in patients scheduled for same day hysterectomy is therefore conducted.', 'detailedDescription': 'Background with aim: Hysterectomy is the most common major gynaecological procedure in the world and hysterectomy on benign indications are increasingly being performed as same-day surgery. Therefore, perioperative anaesthesia has moved towards the use of very short-acting opioids with the incitement to speed up extubation and facilitate hospital discharge. However, the potential consequence is that more patients experience pain and discomfort.\n\nMethadone has several desirable pharmacological features, and a single intraoperative dose of the long acting opioid could therefore theoretically expand the analgesic window and reduce postoperative opioid consumption compared to the more conventional use of short-acting opioids. The aim of this study is to investigate the effect of a single-dose of intravenous intraoperative methadone on postoperative opioid consumption, pain and side effects in patients scheduled for hysterectomy for benign indications. Our primary hypothesis is that intravenous perioperative methadone reduces opioid consumption (oral cumulative equivalent dose) by 30% during the first 24 postoperative hours compared to intravenous morphine.\n\nMethods: 126 patients will be included in an investigator-initiated, prospective, randomised, double-blind, controlled trial with two arms: an intervention arm (methadone 0.2 mg/kg ideal body weight) and a control arm (morphine 0.2 mg/kg ideal body weight). The study will be GCP-monitored, and is approved by the Danish Health and Medicines Authority (2018-004351-20) and the Central Denmark Region Committees on Health Research Ethics (1-10-72-365-18).\n\nHypothesis: The results will probably be applicable to other types of surgery involving visceral pain, and thus the present study has the potential to improve the pain management for a large number of patients undergoing surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients scheduled for elective laparoscopic hysterectomy for benign indications\n\nExclusion Criteria:\n\n* American Society of Anaesthesiologists (ASA) physical status IV or V\n* prolonged QT-interval assessed by electrocardiogram (\\> 440 milliseconds)\n* Existing treatment with medications prolonging the QT-interval\n* Hysterectomy due to malignancy or acute bleeding disorders\n* Allergy to study drugs\n* Preoperative daily use of opioids\n* Severe respiratory insufficiency\n* Heart failure\n* Acute alcohol intoxication/delirium tremens\n* Increased intracranial pressure\n* Acute liver disease\n* Acute abdominal pain\n* Liver insufficiency\n* Kidney insufficiency\n* Treatment with rifampicin\n* Breastfeeding\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT03908060', 'briefTitle': 'Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Clinical Effectiveness and Safety of Intraoperative Methadone in Patients Undergoing Laparoscopic Hysterectomy: a Prospective, Double-blind, Randomised Controlled Trial', 'orgStudyIdInfo': {'id': '01052019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravenous single-dose methadone', 'description': 'A 10 ml syringe with 2 mg/ml of methadone will be prepared and and study drug will be administered as intravenous bolus dose (0.2 mg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (height (cm) - 105).', 'interventionNames': ['Drug: Methadone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous single-dose morphine', 'description': 'A 10 ml syringe with 2 mg/ml of morphine will be prepared and study drug will be administered as intravenous bolus dose (0.2 mg/kg) corresponding to 1 ml for every 10 kg of ideal body weight (height (cm) - 105).', 'interventionNames': ['Drug: Morphine']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'description': 'One intravenous administration of methadone (0.2 mg/kg ideal body weight)', 'armGroupLabels': ['Intravenous single-dose methadone']}, {'name': 'Morphine', 'type': 'DRUG', 'description': 'One intravenous administration of morphine (0.2 mg/kg ideal body weight)', 'armGroupLabels': ['Intravenous single-dose morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8700', 'city': 'Horsens', 'state': 'Central Jutland', 'country': 'Denmark', 'facility': 'Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital', 'geoPoint': {'lat': 55.86066, 'lon': 9.85034}}], 'overallOfficials': [{'name': 'Kristian Friesgaard, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anaesthesiology and Intensive Care, Horsens Regional Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}