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

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03266445
Enrollment
76
Registered
2017-08-30
Start date
2018-10-05
Completion date
2022-02-26
Last updated
2018-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid-use Disorder, Pain, Acute, Surgery

Keywords

relapse, buprenorphine/naloxone, opioids, narcotics, post-surgical pain

Brief 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.

Detailed 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.

Interventions

DRUGbuprenorphine/naloxone

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

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 8mg prior to surgery. Each group will have identical perioperative treatment plans. Primary outcome measured is pain scores following surgery.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain scores24 hours after surgeryLevel 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.

Secondary

MeasureTime frameDescription
Postoperative opioid consumption24 hours, 48 hours and 72 hours after surgeryAmount of opioids needed for pain control postoperatively
Post-operative pain scores48 hours, 72 hours after surgeryLevel 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.
Presence, severity of substance abuse1 month after surgeryParticipants will complete questionnaires to identify the presence and severity of substance abuse.These values will be compared with baseline values obtained preoperatively.

Contacts

Primary ContactAurora Quaye, MD
aquaye@partners.org617-726-2000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026