Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
NCT ID: NCT03266445
Last Updated: 2018-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
76 participants
INTERVENTIONAL
2018-10-05
2022-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FULL-BUPRENORPHINE
Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone
buprenorphine/naloxone
The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
LOW-BUPRENORPHINE (control)
Participants will be randomly assigned to have their daily dose of buprenorphine/naloxone reduced to 8mg on the day of surgery
No interventions assigned to this group
Interventions
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buprenorphine/naloxone
The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* on buprenorphine or buprenorphine/naloxone dose of greater than 8mg for at least 30 days
* ASA health class I-III
Exclusion Criteria
* Significant pulmonary or cardiac disease
* Renal insufficiency with a glomerular filtration rate less than 30ml/min
* Liver cirrhosis with a Model for End-Stage Liver Disease (MELD) score of greater than 25
18 Years
65 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Aurora Naa-Afoley Quaye
Instructor M.D.
Principal Investigators
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Aurora Quaye, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Central Contacts
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References
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McLellan AT, Lewis DC, O'Brien CP, Kleber HD. Drug dependence, a chronic medical illness: implications for treatment, insurance, and outcomes evaluation. JAMA. 2000 Oct 4;284(13):1689-95. doi: 10.1001/jama.284.13.1689.
Scott CK, Dennis ML, Laudet A, Funk RR, Simeone RS. Surviving drug addiction: the effect of treatment and abstinence on mortality. Am J Public Health. 2011 Apr;101(4):737-44. doi: 10.2105/AJPH.2010.197038. Epub 2011 Feb 17.
Degenhardt L, Bucello C, Mathers B, Briegleb C, Ali H, Hickman M, McLaren J. Mortality among regular or dependent users of heroin and other opioids: a systematic review and meta-analysis of cohort studies. Addiction. 2011 Jan;106(1):32-51. doi: 10.1111/j.1360-0443.2010.03140.x. Epub 2010 Nov 4.
Schuckit MA. Treatment of Opioid-Use Disorders. N Engl J Med. 2016 Jul 28;375(4):357-68. doi: 10.1056/NEJMra1604339. No abstract available.
Gordon AJ, Lo-Ciganic WH, Cochran G, Gellad WF, Cathers T, Kelley D, Donohue JM. Patterns and Quality of Buprenorphine Opioid Agonist Treatment in a Large Medicaid Program. J Addict Med. 2015 Nov-Dec;9(6):470-7. doi: 10.1097/ADM.0000000000000164.
Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. doi: 10.1177/0310057X0503300104.
Bryson EO. The perioperative management of patients maintained on medications used to manage opioid addiction. Curr Opin Anaesthesiol. 2014 Jun;27(3):359-64. doi: 10.1097/ACO.0000000000000052.
McCormick Z, Chu SK, Chang-Chien GC, Joseph P. Acute pain control challenges with buprenorphine/naloxone therapy in a patient with compartment syndrome secondary to McArdle's disease: a case report and review. Pain Med. 2013 Aug;14(8):1187-91. doi: 10.1111/pme.12135. Epub 2013 May 3.
Huang A, Katznelson R, de Perrot M, Clarke H. Perioperative management of a patient undergoing Clagett window closure stabilized on Suboxone(R) for chronic pain: a case report. Can J Anaesth. 2014 Sep;61(9):826-31. doi: 10.1007/s12630-014-0193-y. Epub 2014 Jul 2.
Kornfeld H, Manfredi L. Effectiveness of full agonist opioids in patients stabilized on buprenorphine undergoing major surgery: a case series. Am J Ther. 2010 Sep-Oct;17(5):523-8. doi: 10.1097/MJT.0b013e3181be0804.
Macintyre PE, Russell RA, Usher KA, Gaughwin M, Huxtable CA. Pain relief and opioid requirements in the first 24 hours after surgery in patients taking buprenorphine and methadone opioid substitution therapy. Anaesth Intensive Care. 2013 Mar;41(2):222-30. doi: 10.1177/0310057X1304100212.
Kelly AM. The minimum clinically significant difference in visual analogue scale pain score does not differ with severity of pain. Emerg Med J. 2001 May;18(3):205-7. doi: 10.1136/emj.18.3.205.
Wilkinson KM, Krige A, Brearley SG, Lane S, Scott M, Gordon AC, Carlson GL. Thoracic Epidural analgesia versus Rectus Sheath Catheters for open midline incisions in major abdominal surgery within an enhanced recovery programme (TERSC): study protocol for a randomised controlled trial. Trials. 2014 Oct 21;15:400. doi: 10.1186/1745-6215-15-400.
Related Links
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Center for Behavioral Health Statistics and Quality. Behavioral health trends in the United States: Results from the 2014 National Survey on Drug Use and Health. 2015. HHS Publication No. SMA 15-4927, NSDUH Series H-50.
Other Identifiers
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2017P001425
Identifier Type: -
Identifier Source: org_study_id
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