Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03266445
• Other study ID #: 2017P001425
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 5, 2018
• Est. completion date: February 26, 2022

Study information

• Verified date: October 2018
• Source: Massachusetts General Hospital
• Contact: Aurora Quaye, MD
• Phone: 617-726-2000
• Email: aquaye[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: February 26, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Opioid-use Disorder
• Pain, Acute
• Surgery

Intervention

Drug:
• buprenorphine/naloxone
The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

References & Publications (13)

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

Huang A, Katznelson R, de Perrot M, Clarke H. Perioperative management of a patient undergoing Clagett window closure stabilized on Suboxone® 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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Roberts DM, Meyer-Witting M. High-dose buprenorphine: perioperative precautions and management strategies. Anaesth Intensive Care. 2005 Feb;33(1):17-25. Review. — View Citation

Schuckit MA. Treatment of Opioid-Use Disorders. N Engl J Med. 2016 Jul 28;375(4):357-68. doi: 10.1056/NEJMra1604339. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain scores	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
Secondary	Postoperative opioid consumption	Amount of opioids needed for pain control postoperatively	24 hours, 48 hours and 72 hours after surgery
Secondary	Post-operative pain scores	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
Secondary	Presence, severity of substance abuse	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

External Links

•   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.