Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-02-22 @ 9:39 AM
Study NCT ID:
NCT01125059
Status:
WITHDRAWN
Last Update Posted:
2015-04-22
First Post:
2010-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methadone Versus Placebo in Spine Fusion
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': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D007659', 'term': 'Ketones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Unable to fulfill recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2010-05-11', 'studyFirstSubmitQcDate': '2010-05-17', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hydromorphone postoperative opioid consumption (POC) at 48 hours', 'timeFrame': '48 hrs', 'description': 'PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU'}], 'secondaryOutcomes': [{'measure': 'Intraoperative remifentanil consumption', 'timeFrame': 'the 8 hours prior to arrival in the recovery room', 'description': 'intraoperative consumption of remifentanil--the amount of remifentanil used in the OR (i.e., the 2-8 hours prior to arrival in the recovery room)'}, {'measure': 'pain at rest and with movement (numerical Rating Scale, NRS)', 'timeFrame': '1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs'}, {'measure': "the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)", 'timeFrame': '1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs'}, {'measure': 'the number of occurrences of ventilatory depression during each evaluation interval', 'timeFrame': '1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs'}, {'measure': 'number of occurrences of nausea (resulting in treatment)', 'timeFrame': '1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs'}, {'measure': 'recorded emesis', 'timeFrame': '1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs'}, {'measure': 'occurrence of pruritus', 'timeFrame': '1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs'}, {'measure': 'Hydromorphone postoperative opioid consumption (POC)', 'timeFrame': '1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs', 'description': 'PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hydromorphone', 'lumbar posterior spinal fusion', 'lumbosacral spondylosis', 'Spinal Fusion'], 'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '7500538', 'type': 'BACKGROUND', 'citation': 'Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA. 1995 Dec 20;274(23):1870-3.'}, {'pmid': '9314613', 'type': 'BACKGROUND', 'citation': 'Upton RN, Semple TJ, Macintyre PE. Pharmacokinetic optimisation of opioid treatment in acute pain therapy. Clin Pharmacokinet. 1997 Sep;33(3):225-44. doi: 10.2165/00003088-199733030-00005.'}, {'pmid': '16226953', 'type': 'BACKGROUND', 'citation': 'Taylor S, Kirton OC, Staff I, Kozol RA. Postoperative day one: a high risk period for respiratory events. Am J Surg. 2005 Nov;190(5):752-6. doi: 10.1016/j.amjsurg.2005.07.015.'}, {'pmid': '14599609', 'type': 'BACKGROUND', 'citation': 'Taylor S, Voytovich AE, Kozol RA. Has the pendulum swung too far in postoperative pain control? Am J Surg. 2003 Nov;186(5):472-5. doi: 10.1016/j.amjsurg.2003.07.021.'}, {'pmid': '11133596', 'type': 'BACKGROUND', 'citation': 'Liu N, Kuhlman G, Dalibon N, Moutafis M, Levron JC, Fischler M. A randomized, double-blinded comparison of intrathecal morphine, sufentanil and their combination versus IV morphine patient-controlled analgesia for postthoracotomy pain. Anesth Analg. 2001 Jan;92(1):31-6. doi: 10.1097/00000539-200101000-00007.'}, {'pmid': '11732383', 'type': 'BACKGROUND', 'citation': 'Joris J, Kaba A, Lamy M. Transition between anesthesia and post-operative analgesia: relevance of intra-operative administration of analgesics. Acta Anaesthesiol Belg. 2001;52(3):271-9.'}, {'pmid': '15635517', 'type': 'BACKGROUND', 'citation': 'Carroll IR, Angst MS, Clark JD. Management of perioperative pain in patients chronically consuming opioids. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):576-91. doi: 10.1016/j.rapm.2004.06.009.'}, {'pmid': '10393880', 'type': 'BACKGROUND', 'citation': 'Yaksh TL, Hua XY, Kalcheva I, Nozaki-Taguchi N, Marsala M. The spinal biology in humans and animals of pain states generated by persistent small afferent input. Proc Natl Acad Sci U S A. 1999 Jul 6;96(14):7680-6. doi: 10.1073/pnas.96.14.7680.'}, {'pmid': '1539846', 'type': 'BACKGROUND', 'citation': 'Parker RK, Holtmann B, White PF. Effects of a nighttime opioid infusion with PCA therapy on patient comfort and analgesic requirements after abdominal hysterectomy. Anesthesiology. 1992 Mar;76(3):362-7. doi: 10.1097/00000542-199203000-00007.'}, {'pmid': '6128949', 'type': 'BACKGROUND', 'citation': 'Gourlay GK, Wilson PR, Glynn CJ. Pharmacodynamics and pharmacokinetics of methadone during the perioperative period. Anesthesiology. 1982 Dec;57(6):458-67. doi: 10.1097/00000542-198212000-00005. No abstract available.'}, {'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': '9743391', 'type': 'BACKGROUND', 'citation': 'Egan TD, Huizinga B, Gupta SK, Jaarsma RL, Sperry RJ, Yee JB, Muir KT. Remifentanil pharmacokinetics in obese versus lean patients. Anesthesiology. 1998 Sep;89(3):562-73. doi: 10.1097/00000542-199809000-00004.'}, {'pmid': '16105412', 'type': 'BACKGROUND', 'citation': 'Lemmens HJ, Brodsky JB, Bernstein DP. Estimating ideal body weight--a new formula. Obes Surg. 2005 Aug;15(7):1082-3. doi: 10.1381/0960892054621350.'}, {'pmid': '15155330', 'type': 'BACKGROUND', 'citation': 'Bowdle TA, Even A, Shen DD, Swardstrom M. Methadone for the induction of anesthesia: plasma histamine concentration, arterial blood pressure, and heart rate. Anesth Analg. 2004 Jun;98(6):1692-1697. doi: 10.1213/01.ANE.0000114085.20751.20.'}, {'pmid': '2286697', 'type': 'BACKGROUND', 'citation': "Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51."}, {'pmid': '15333398', 'type': 'BACKGROUND', 'citation': 'Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709. doi: 10.1213/01.ANE.0000133143.60584.38.'}, {'pmid': '19461298', 'type': 'BACKGROUND', 'citation': 'van Dorp EL, Kest B, Kowalczyk WJ, Morariu AM, Waxman AR, Arout CA, Dahan A, Sarton EY. Morphine-6beta-glucuronide rapidly increases pain sensitivity independently of opioid receptor activity in mice and humans. Anesthesiology. 2009 Jun;110(6):1356-63. doi: 10.1097/ALN.0b013e3181a105de.'}]}, 'descriptionModule': {'briefSummary': 'What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine each day? What is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?', 'detailedDescription': 'Hypothesis:\n\n1. We hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg IV morphine a day undergoing lumbar interbody fusion.\n2. We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA physical status I, II, and III, male and non-pregnant female\n* English-speaking patients\n* Ages 18-75 years\n* Undergoing elective one or two level posterior lumbar interbody fusion\n\nExclusion Criteria:\n\n* Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.\n* Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin).\n* history of substance abuse at any time in the past\n* known QT prolongation\n* Non-elective operations (i.e., cancer or trauma)\n* severe hepatic impairment (serum albumin \\< 3.0 g/dL in the presence of a history of liver disease)\n* pregnancy\n* inability to operate a patient-controlled analgesia device'}, 'identificationModule': {'nctId': 'NCT01125059', 'briefTitle': 'Methadone Versus Placebo in Spine Fusion', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study', 'orgStudyIdInfo': {'id': 'STU00027431'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Methadone Group', 'description': '0.2 mg/kg IV methadone', 'interventionNames': ['Drug: Methadone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': '5 mL saline bolus', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Methadone', 'type': 'DRUG', 'otherNames': ['Dolophine'], 'description': '0.2 mg/kg methadone IV bolus', 'armGroupLabels': ['Methadone Group']}, {'name': 'Saline', 'type': 'DRUG', 'otherNames': ['0.9 NaCl'], 'description': '3 mL saline IV bolus', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Dhanesh K Gupta, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwestern University Feinberg School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwestern University Feinberg School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Anesthesiology & Neurological Surgery', 'investigatorFullName': 'Dhanesh Gupta', 'investigatorAffiliation': 'Northwestern University'}}}}