Clinical Research Directory

Mindfulness in Fracture Recovery and Reduction of Opioid Reliance: Evaluating the Feasibility of Implementing a Brief, Mindfulness-based Intervention to Manage Pain and Anxiety Before and After Fracture Surgery

Breaking a bone is not only physically painful but also emotionally overwhelming. Patients often experience intense pain, anxiety, and uncertainty as they are rushed to hospital, undergo emergency treatment, and prepare for surgery. After surgery, many continue to struggle with pain and rely on opioid medications, which carry serious risks including addiction. In the context of our current opioid epidemic, it's critical that alternative treatment strategies are urgently evaluated. Mindfulness is a practice that helps people focus on the present and has been shown to reduce stress and pain in other settings. In this trial, patients with broken arms or legs who need surgery at Hamilton General Hospital will be randomly assigned to one of two groups who will listen to a two-part, audio recording before and after surgery. Those in the interventional group will engage in a 7-minute audio-guided mindfulness exercise before surgery to help reduce anxiety, and another 7-minute audio-guided mindfulness exercise after surgery to help manage pain. Those in the control group will listen to a 7-minute educational audio recording before surgery and again after surgery. The main goal is to see if this approach is practical-can enough patients be recruited, and will they complete the audio recordings? The study will also look at early signs of whether the intervention helps reduce pain, anxiety, and opioid use six weeks after surgery. If feasible, a larger study can be conducted to determine if these exercises can help patients manage pain and reduce their need for opioids after surgery. If successful, this simple, low-cost approach could be widely used in hospitals to support recovery and reduce reliance on pain medications.

Opioid Analgesic Reduction Study

The goal is to provide health care professionals, including dentists, with the best possible evidence for clinical decision making when deciding upon analgesics for acute post-surgical pain management, a double-blind, stratified randomized clinical trial will be conducted to test the hypothesis that a combination of over-the-counter non-opioid containing analgesics is at least as, if not more, effective (non-inferior) than the most commonly prescribed opioid analgesic. The impacted 3rd molar extraction model will be used due to the predictable severity of the post-operative pain and generalizability of results. This double-blind, prospective, stratified, randomized pragmatic clinical trial will use the impacted 3rd molar extraction pain model.

Non-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3

This study is being done to answer the question: what is the effect of Vagal Nerve Stimulation (VNS) dosing on opioid withdrawal responses in individuals with a history of Opioid Use Disorders (OUDs)? Eligible participants will be in the study for one week in an inpatient research hospital stay, have an MRI scan, and have a follow-up call 1-3 months after their inpatient stay. Participants will complete several psychiatric questionnaires/interviews, physiological monitoring with several devices, brain imaging, and VNS testing.

Facilitating Opioid Care Connections

In response to the opioid crisis in New York State (NYS), where the propose project will take place, the Unified Court System (UCS) developed a new treatment court model - the opioid court model (OCM) - designed around 10 practice guidelines to address the flaws of existing drug courts and reduce overdose (OD), opioid use disorder (OUD), and recidivism via rapid screening and linkage to medication for opioid use disorder (MOUD). In 2018, NYS began to expand the OCM across NYS. Yet, given the innovation of the OCM, the exact barriers to implementation in disparate counties with a range of resources - and the strategies to overcome them - are largely unknown. The research team proposes to integrate evidence-based implementation strategies to refine and evaluate the Opioid Court Model Rigorous Implementation Science for Effectiveness (OCM RISE) intervention, an implementation intervention that will allow the OCM, as framed by the 10 practice guidelines, to be scaled up across NYS.

A Pain and Coordination Plan for Reduced Opioid Use After Accidental Injuries

This clinical trial aims to lower the number of people who use opioids and improve the quality of health in patients who have experienced accidental injury by implementing a Pain and Coordination Plan (PAC-plan). The PAC-plan will be given upon discharge from the hospital. The main questions this study aims to answer are: * Can the PAC-plan reduce opioid use in patients after accidental injuries? * Can the PAC-plan increase quality of life in patients after accidental injuries? * Is implementation of the PAC-plan after accidental injuries cost-effective? Participants will be randomly assigned to the PAC-plan or usual care. The PAC-plan includes: * an opioid management plan upon discharge from the hospital * an appointment with his/her general practitioner within 2-4 weeks after discharge * the general practitioner will be given the opportunity for increased collaboration with the hospital specialists Participants in both groups will be asked to answer questionnaires about their health at discharge, and at 6 and 52 weeks after discharge from the hospital. In addition, the researchers will use data from the Norwegian Prescription Database to measure use of opioids and other relevant drugs, the Norwegian Patient Registry (NPR) and the Norwegian Registry for Primary Health Care (KPR) for the use of health care services and Statistics Norway for data on sick leave and other social security benefits.

Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients

The goal of this clinical trial is to learn if ketamine, given during surgery, can help improve recovery for adults with serious orthopedic trauma. The study will test whether ketamine reduces pain, lowers the need for opioids, and improves mental health outcomes like depression and post-traumatic stress disorder (PTSD). The main questions it aims to answer are: Does ketamine reduce pain after surgery compared to standard anesthesia? Does ketamine reduce the amount of opioids patients need for pain control? Does ketamine improve symptoms of depression and PTSD after orthopedic trauma? Researchers will compare patients who receive ketamine during surgery with those who receive standard anesthesia without ketamine to see if ketamine helps improve both physical and psychological recovery. Participants will: Be randomly assigned to receive either a single dose of ketamine or standard anesthesia during surgery. Report their pain using a simple pain scale (Visual Analog Scale, VAS). Complete short surveys about mood and mental health (PHQ-9 for depression and PCL-5 for PTSD) at several time points after surgery. Allow the research team to review their electronic medical records to measure opioid prescriptions during recovery. Attend follow-up visits in clinic or by secure telehealth (e.g., Zoom) at 1-7 days, 2-3 weeks, 6 weeks, 3 months, and 6 months after surgery

Machine-Learning Prediction and Reducing Overdoses With EHR Nudges

The goal of this cluster randomized clinical trial is to test a clinician-targeted behavioral nudge intervention in the Electronic Health Record (EHR) for patients who are identified by a machine-learning based risk prediction model as having an elevated risk for an opioid overdose. The clinical trial will evaluate the effectiveness of providing a flag in the EHR to identify individuals at elevated risk with and without behavioral nudges/best practice alerts (BPAs) as compared to usual care by primary care clinicians. The primary goals of the study are to improve opioid prescribing safety and reduce overdose risk.

Pain Alleviation With Testosterone in Opioid-Induced Hypogonadism

The aim of this trial is to evaluate whether testosterone replacement results in greater improvement in pain perception, pain tolerance, sexual function, fatigue, and quality of life when compared with placebo in men with chronic spinal pain treated with opioids who have opioid-induced hypogonadism (low testosterone).

Effects of Erector Spinae Plane Block on Postoperative Pain Following Lumbar Fusion Surgery

The purpose of this study is to determine if the method for injecting local anesthesia affects patients' pain and opioid usage after surgery. The investigators will compare subcutaneous anesthesia, injections of anesthesia under the skin, to a method called erector spinae plane block (ESPB). An ESPB injection involves placing local anesthesia along the muscles and bones in the back, using a special type of x-ray called fluoroscopy for guidance. The Investigators will use patient reported outcomes (PROs) and track subjects' opioid usage to find out if there is a difference between ESPB and subcutaneous anesthesia. The investigators hypothesize that patients who get ESPB injections will use less opioids and report less pain after lumbar fusion surgery compared to patients who receive subcutaneous anesthesia injections.

Evaluation of the Safety and Effects of Psychoactive Substances in People With Past Opioid Use

The purpose of this study is to understand how kratom affects people. In this study, kratom will be compared with another substance and a placebo (an inactive substance). Researchers will also study how the substances move through and affect the body. This includes examining how the body absorbs, processes, and eliminates the drug (pharmacokinetics), as well as how the drug affects the body and how it may make you feel (pharmacodynamics). The information collected will help researchers better understand the effects and potential risks of kratom.

Virtual Reality and Olfactory Stimuli Multimodal Intervention to Reduce Post-Operative Pain and Anxiety in Patients Undergoing Cardiothoracic Surgery

Patients who undergo cardiothoracic surgery often experience pain and anxiety around the time of surgery. Currently, treatments for pain and anxiety around the time of surgery include opioids and benzodiazepines, which can have severe side effects and can be ineffective. Interventions combining virtual reality with olfactory stimuli are a promising alternative to opioids and benzodiazepines in the treatment of pain and anxiety around the time of surgery. The aim of this study is to evaluate the feasibility of a virtual reality and olfactory stimuli multimodal intervention in patients undergoing cardiothoracic surgery. In addition, the investigators will evaluate the preliminary effects of the VR/OS intervention on patient pain and anxiety before and after cardiothoracic surgery. Patients who meet study inclusion criteria and are undergoing cardiothoracic surgery may participate in this study. Patients have an equal being assigned to undergo the virtual reality and olfactory stimuli intervention or continue getting usual medical care with their doctor. If the patient is assigned to receive the virtual reality and olfactory stimuli intervention, the first therapy session will take place approximately two to four weeks before surgery. This will involve wearing a virtual reality headset and scented necklace for approximately 10 minutes. The second session will occur 90 minutes before the surgery. Additionally, for each day the patient recovers in the hospital after surgery, the patient will receive one session in the afternoon. During the patient's in-hospital recovery at night, they will receive lavender scented therapy.

Exparel vs. Marcaine ESP Block for Post-cardiac Surgical Pain

The goal of this pilot study is to describe and compare Ultrasound-Guided Erector Spinae Plane (ESP) Blocks using Exparel® (bupivacaine liposome injectable suspension) to Marcaine® (bupivacaine hydrochloride) for pain management and outcomes after cardiac surgeries.

Pregabalin Plus Lofexidine for the Outpatient Treatment of Opioid Withdrawal

A placebo-controlled trial in which male and female outpatients with an opioid use disorder who express interest in extended-release injectable naltrexone (XR-NTX) are randomized 1:1 to lofexidine/pregabalin or lofexidine/pregabalin placebo for withdrawal management and offered XR-NTX if after completing withdrawal.

Encouraging Abstinence Behavior in a Drug Epidemic: Optimizing Dynamic Incentives

Combatting the rise of the opioid epidemic is a central challenge of U.S. health care policy. A promising approach for improving welfare and decreasing medical costs of people with substance abuse disorders is offering incentive payments for healthy behaviors. This approach, broadly known as "contingency management" in the medical literature, has repeatedly shown to be effective in treating substance abuse. However, the use of incentives by treatment facilities remains extremely low. Furthermore, it is not well understood how to design optimal incentives to treat opioid abuse. This project will conduct a randomized evaluation of two types of dynamically adjusting incentive schedules for people with opioid use disorders or cocaine use disorders: "escalating" schedules where incentive amounts increase with success to increase incentive power, and "de-escalating" schedules where incentive amounts decrease with success to improve incentive targeting. Both schemes are implemented with a novel "turnkey" mobile application, making them uniquely low-cost, low-hassle, and scalable. Effects will be measured on abstinence outcomes, including longest duration of abstinence and the percentage of negative drug tests. In combination with survey data, variation from the experiment will shed light on the barriers to abstinence more broadly and inform the understanding of optimal incentive design.

ENDOblock: Bilateral Superficial Cervical Blocks With Local Wound Infiltration in Thyroid Surgery

This is a single center, prospective, double-blinded randomized controlled trial comparing the efficacy of bilateral superficial cervical plexus blocks (BSCPB) with local wound infiltration vs placebo with local wound infiltration in reducing thyroid surgery postoperative pain. Primary outcomes assessed are post operative pain, quality of life/recovery, post operative nausea/vomiting and opioid use.

Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

The purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy. This study will determine 1) whether the most commonly used non-narcotic medications provide pain relief comparable with the most commonly prescribed narcotic medications in patients undergoing arthroscopic knee surgery, and 2) whether patients' characteristics (gender, pre-operative knee symptoms, workers compensation status and employment status) affect pain level following surgery or medication usage.

Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.

Patient Utilization of Opioid Destruction Bags in the Post-op Period

This is a study on how patients use and store opioid pain medications at home after surgery and what happens to left over pills when patients are done taking them. Participants will be taught the proper storage and destruction of opioid pain medications, then contacted in 6-8 weeks about pain medication used, stored disposed of.

Autonomic Neural Blockade in Bariatric Surgery

The purpose of this research is to evaluate if autonomic nerve block (ANB- blocking pain and nausea signals) decreases pain and anti-nausea medication requirements as well as the experience of pain/nausea during the first 72 hours after sleeve gastrectomy or gastric bypass surgery. Participants will be randomly assigned either to the standard of care or the ANB group before surgery. As part of standard of care, in both groups, laparoscopic bariatric surgery will be initiated with local anesthetic injected into the abdominal wall. In the ANB group, participants will be given an additional injection of local anesthetic medication to block nerves on and around the stomach.

Autonomic Neural Field Block for Visceral Pain in Minimally Invasive Left-Sided Colectomy

Effective postoperative pain control is a core component of enhanced recovery after surgery (ERAS) pathways in colorectal surgery; however, postoperative pain following minimally invasive left-sided colectomy remains a persistent clinical challenge. Standard multimodal analgesic strategies primarily target somatic pain pathways and may inadequately address visceral postoperative pain, which is mediated through autonomic afferent neural pathways. Residual visceral pain is associated with increased opioid consumption, postoperative nausea and vomiting, delayed recovery, and prolonged length of stay. This prospective, multicenter observational registry evaluates the feasibility and real-world outcomes of an intraoperative autonomic neural field block targeting the superior hypogastric and inferior mesenteric plexuses during minimally invasive left-sided colectomy. The technique is performed under direct visualization as an adjunct to standard ERAS-based analgesic care. The primary outcome is postoperative opioid consumption within the first 24 hours after surgery. Secondary outcomes include opioid use through 48 hours, postoperative nausea and vomiting, antiemetic use, pain scores, length of stay, and readiness for discharge. Data from this registry will inform future comparative studies and help define the role of autonomic neural modulation in perioperative pain management for colorectal surgery.

Opioid Use Post-Discharge After Ambulatory Distal Arm Surgery

The aim of this study is to determine if a standardized evidence-based opioid prescription following elective hand and forearm surgery at Toronto Western Hospital (TWH) will decrease the number of unused opioid pills consumed by patients while still maintaining adequate pain control as compared to usual treatment. Currently, no standardized prescription exists at our institution.

Lumbar Steroid Use in Patients Undergoing Posterior Lumbar Decompression

This study seeks to evaluate the impact of intra-operative topical epidural steroid usage in patients undergoing 1-2 level lumbar laminectomy. The study will examine post-operative opioid usage, length of stay, return to work, and patient reported outcomes following these procedures.

Better Experiences in Substance Treatment: A Brief Alcohol-focused Intervention Tailored for Patients in Opioid Agonist Treatment

This study will help determine the feasibility and acceptability of a brief opioid-informed alcohol intervention in patients receiving prescribed buprenorphine for opioid use who are currently drinking alcohol. It will also provide initial information on whether the intervention improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.

Enhanced Recovery After Major Surgery and Chronic Pain for Total Knee Arthroplasty

The goal of this interventional clinical trial is to assess opioid consumption 24-48 hrs post anesthesia block among patients undergoing total knee arthroplasty. The main question it aims to answer is: 1\. Is there a difference in opioid consumption 24-48 hours post block administration among patients that receive an adductor canal catheter (ACC) versus adductor canal block (ACB)? Participants will be: * Randomized to receive an adductor canal catheter (ACC) or a sham adductor canal catheter. * Asked to use the Diagnotes application to communicate with the pain doctor while the catheter is in place. * Follow up for up to 6 months post-operation. Researchers will compare the interventional group (ACC) to the control group (sham ACC + ACB) to see if there is difference in opioid consumption and chronic pain at 6 months post-operation.