Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
2018年10月5日 更新者:Aurora Naa-Afoley Quaye、Massachusetts General Hospital
A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post Operative Opioid Use Disorder Symptoms
The aim of this study is to determine the effect of continuation of buprenorphine/naloxone in patients with history of Opioid Use Disorder (OUD) scheduled for surgery compared to reduced dose buprenorphine/naloxone prior to surgery on pain scores, opioid consumption, depressive symptoms and severity of substance use dependence- including record of problematic use of any non-prescribed opioids, alcohol and illicit narcotics.
研究概览
详细说明
Opioid use disorder (OUD) is characterized by non-remitting cycles of remission and opioid abuse relapse.
It is associated with a high rate of psychiatric and physical co-morbidity when left untreated.
Buprenorphine and buprenorphine/naloxone are effective opioid maintenance therapy (OMT) for OUD, however, treatment of acute post-surgical pain in patients taking buprenorphine is perceived to be challenging.
Although not substantiated in clinical studies, the combination of high receptor binding affinity, long half-life, and partial mu opioid receptor agonism with buprenorphine/naloxone are thought to inhibit the analgesic actions of full mu opioid receptor agonists, potentially making standard postoperative pain control strategies less effective.
There is no evidence based standard of care for optimal acute pain management strategies for patients taking buprenorphine and most recommendations are based upon provider opinion- occasionally conflicting along specialty lines.
Some providers, mainly consisting of surgeons and anesthesiologists, recommend that buprenorphine should be discontinued at least 72 hours prior to elective surgery and replaced with low dose opioid agonists, in the interim.
Other providers, mainly comprising of psychiatrists, contend that these patients should be maintained on buprenorphine throughout the peri-operative period at either a full or reduced dose to prevent an indeterminate risk of substance abuse relapse that can occur as consequence to the abrupt termination buprenorphine in the highly stressful surgical period.
This study aims to inform this important unresolved question in the clinical care of this growing population.
The investigators seek to determine the effectiveness of managing postoperative pain in patients with OUD where buprenorphine/naloxone is continued perioperatively compared to patients where buprenorphine/naloxone is reduced to a lower dose.
Longitudinally, the investigators also intend to determine if there is a difference in substance abuse relapse in patients where buprenorphine/naloxone is continued vs. held by using self assessments and communication with the participant's buprenorphine provider.
研究类型
介入性
注册 (预期的)
76
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- currently taking buprenorphine or buprenorphine/naloxone daily for treatment of opioid use disorder by DSM-V criteria
- on buprenorphine or buprenorphine/naloxone dose of greater than 8mg for at least 30 days
- ASA health class I-III
Exclusion Criteria:
- Unable to consent to the study
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:FULL-BUPRENORPHINE
Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone
|
The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
其他名称:
|
|
无干预:LOW-BUPRENORPHINE (control)
Participants will be randomly assigned to have their daily dose of buprenorphine/naloxone reduced to 8mg on the day of surgery
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Post-operative pain scores
大体时间:24 hours after surgery
|
Level of pain on a Visual Analog Scale of 0-100 (0=no pain; 100=worst pain imaginable) This scale will be used to quantify the varying degrees of pain or discomfort experienced by the participant.
|
24 hours after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Postoperative opioid consumption
大体时间:24 hours, 48 hours and 72 hours after surgery
|
Amount of opioids needed for pain control postoperatively
|
24 hours, 48 hours and 72 hours after surgery
|
|
Post-operative pain scores
大体时间:48 hours, 72 hours after surgery
|
Level of pain on Visual Analog Scale 0-100 (0= no pain 100= worst pain imaginable) We will compare the results of the 48 and 72 hour time-points with the 24 hour time-point.
|
48 hours, 72 hours after surgery
|
|
Presence, severity of substance abuse
大体时间:1 month after surgery
|
Participants will complete questionnaires to identify the presence and severity of substance abuse.These values will be compared with baseline values obtained preoperatively.
|
1 month after surgery
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Aurora Quaye, MD、Massachusetts General Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2018年10月5日
初级完成 (预期的)
2021年12月31日
研究完成 (预期的)
2022年2月26日
研究注册日期
首次提交
2017年8月28日
首先提交符合 QC 标准的
2017年8月28日
首次发布 (实际的)
2017年8月30日
研究记录更新
最后更新发布 (实际的)
2018年10月9日
上次提交的符合 QC 标准的更新
2018年10月5日
最后验证
2018年10月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2017P001425
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
不
IPD 计划说明
IPD will only be available to researchers involved in the study.
All data will be collected and stored securely using the Redcap system to preserve privacy and confidentiality.
Information regarding substance abuse history, including illicit narcotic use, will remain confidential and personal identifiers will be removed during data storage.
Only members of the research team will have access to the data that participants have consented to provide.
Participants will be informed that they have the right to not answer any question that makes them feel uncomfortable.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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