- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01125059
Methadone Versus Placebo in Spine Fusion
April 21, 2015 updated by: Dhanesh Gupta, Northwestern University
The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study
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?
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Hypothesis:
- 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.
- We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern Memorial Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- ASA physical status I, II, and III, male and non-pregnant female
- English-speaking patients
- Ages 18-75 years
- Undergoing elective one or two level posterior lumbar interbody fusion
Exclusion Criteria:
- Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.
- 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).
- history of substance abuse at any time in the past
- known QT prolongation
- Non-elective operations (i.e., cancer or trauma)
- severe hepatic impairment (serum albumin < 3.0 g/dL in the presence of a history of liver disease)
- pregnancy
- inability to operate a patient-controlled analgesia device
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Methadone Group
0.2 mg/kg IV methadone
|
0.2 mg/kg methadone IV bolus
Other Names:
|
Placebo Comparator: Placebo Group
5 mL saline bolus
|
3 mL saline IV bolus
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hydromorphone postoperative opioid consumption (POC) at 48 hours
Time Frame: 48 hrs
|
PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU
|
48 hrs
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraoperative remifentanil consumption
Time Frame: the 8 hours prior to arrival in the recovery room
|
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)
|
the 8 hours prior to arrival in the recovery room
|
pain at rest and with movement (numerical Rating Scale, NRS)
Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
|
the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)
Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
|
the number of occurrences of ventilatory depression during each evaluation interval
Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
|
number of occurrences of nausea (resulting in treatment)
Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
|
recorded emesis
Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
|
occurrence of pruritus
Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
|
|
Hydromorphone postoperative opioid consumption (POC)
Time Frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs
|
PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU
|
1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dhanesh K Gupta, M.D., Northwestern University Feinberg School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
May 11, 2010
First Submitted That Met QC Criteria
May 17, 2010
First Posted (Estimate)
May 18, 2010
Study Record Updates
Last Update Posted (Estimate)
April 22, 2015
Last Update Submitted That Met QC Criteria
April 21, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Pain, Postoperative
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Opioid
- Narcotics
- Respiratory System Agents
- Antitussive Agents
- Methadone
Other Study ID Numbers
- STU00027431
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Postoperative Pain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
Ankara City Hospital BilkentRecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | SternotomyTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Aydin Adnan Menderes UniversityCompleted
-
Aydin Adnan Menderes UniversityCompletedAcute Postoperative Pain | Chronic Postoperative PainTurkey
-
Maimonides Medical CenterCompletedPOSTOPERATIVE PAINUnited States
-
University Hospital, AntwerpUnknown
-
VA Office of Research and DevelopmentRecruitingTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty (Postoperative Pain)United States
-
VA Office of Research and DevelopmentCompletedTotal Knee Arthroplasty (Postoperative Pain) | Total Hip Arthroplasty(Postoperative Pain)United States
Clinical Trials on Methadone
-
Pontificia Universidad Catolica de ChileCompletedPain, Postoperative | Opioid Use | Methadone Overdose of Undetermined IntentChile
-
Washington University School of MedicineCompleted
-
University of Southern DenmarkCompletedPain, Postoperative | Pain, Post Operative | Analgesics, Opioid | MethadoneDenmark
-
Washington University School of MedicineCompleted
-
The Miriam HospitalUnknownOpioid-Related DisordersUnited States
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)RecruitingChronic Pain | Opioid Use Disorder | MethadoneUnited States
-
Washington University School of MedicineNational Institute of Neurological Disorders and Stroke (NINDS)WithdrawnPolyneuropathy | HIV-associated NeuropathyUnited States
-
Washington University School of MedicineCompleted
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedOpiate DependenceUnited States
-
University of VirginiaCompleted