Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03266445
Study type Interventional
Source Massachusetts General Hospital
Contact Aurora Quaye, MD
Phone 617-726-2000
Email aquaye@partners.org
Status Not yet recruiting
Phase Phase 4
Start date October 5, 2018
Completion date February 26, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05583916 - Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery N/A
Completed NCT03213314 - HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies N/A
Enrolling by invitation NCT05534490 - Surgery and Functionality in Older Adults N/A
Recruiting NCT04792983 - Cognition and the Immunology of Postoperative Outcomes
Recruiting NCT04612491 - Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
Recruiting NCT04444544 - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed NCT04204785 - Noise in the OR at Induction: Patient and Anesthesiologists Perceptions N/A
Completed NCT03432429 - Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
Completed NCT04176822 - Designing Animated Movie for Preoperative Period N/A
Recruiting NCT05370404 - Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain: N/A
Not yet recruiting NCT05467319 - Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS Phase 3
Recruiting NCT04602429 - Children's Acute Surgical Abdomen Programme
Completed NCT03124901 - Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor N/A
Completed NCT04595695 - The Effect of Clear Masks in Improving Patient Relationships N/A
Recruiting NCT06103136 - Maestro 1.0 Post-Market Registry
Completed NCT05346588 - THRIVE Feasibility Trial Phase 3
Completed NCT04059328 - Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
Recruiting NCT03697278 - Monitoring Postoperative Patient-controlled Analgesia (PCA) N/A
Completed NCT03355547 - Observation of Atelectasis Using Lung Ultrasonography in Children Undergoing General Anesthesia: the Cohort Study for Evaluation of the Relationship Between the Incidence and Severity of Upper Respiratory Tract Infection and the Magnitude of Anesthesia-induced Atelectasis
Recruiting NCT04776954 - Comparison of Normothermia Maintenance Between Resistive Blanket and Forced Air Warming Systems in Renal Transplant Surgery N/A