Clinical Research Directory

Evaluation of Virtual Reality for Reducing Opioid Use After Cardiac and Thoracic Surgery

This clinical trial aims to evaluate the efficacy of virtual reality (VR) as an adjunctive therapeutic method to reduce opioid consumption during the postoperative period of cardiac and thoracic surgeries. Conducted at InCor/HCFMUSP, this single-center, prospective, randomized trial will include 60 patients aged 16 to 40 undergoing procedures such as valve replacements, pulmonary decortication, and video-assisted thoracic surgeries. Patients will be randomized into three groups. The Interactive VR group receives standard anesthesia protocol combined with interactive VR therapy using games and immersive environments. The Passive VR group receives standard protocol combined with passive 360-degree immersive videos. The Control group receives standard anesthesia protocol without VR intervention. The intervention occurs in three daily sessions lasting 30-45 minutes each over the first five postoperative days or until hospital discharge. The primary objective is to measure the reduction in total opioid consumption through medical prescriptions and patient-controlled analgesia (PCA) pump usage. Secondary objectives include pain intensity assessed by the Visual Analogue Scale (VAS), incidence of postoperative nausea and vomiting (PONV), duration of mechanical and non-invasive ventilation, length of stay in the ICU and hospital, occurrence of paralytic ileus, patient satisfaction, and cognitive status using the Mini-Mental State Examination (MMSE). Opioids are standard for postoperative pain but are associated with adverse effects like respiratory depression. VR offers an innovative approach by creating immersive environments that serve as cognitive distractions to modulate pain perception and reduce anxiety. The study anticipates that VR will enhance pain control and improve recovery metrics, serving as a safe and scalable complement to traditional postoperative management.

MedSMA℞T Mobile ED

The goal of this clinical trial is to learn if a new smartphone-based intervention can help with factors related to opioid misuse in parents and adolescent/early adult children. The main question it aims to answer is: • Can this intervention improve knowledge of, and attitudes towards, opioid misuse over traditional opioid-related counseling alone? Participants will, in addition to receiving opioid counseling: * Join an online meeting with research staff to test the smartphone-based intervention * Report demographic information * Complete surveys about opioids * Complete a family medication safety plan * Complete surveys after 3, 6, and 9 months

Fentanyl Versus Opioid Free Multimodal Analgesia for Perioperative Pain Control in Children With Mild to Moderate Obstructive Sleep Apnea

Emphasize that the usage of multimodal analgesia in managing perioperative pain in children with mild to moderate Obstructive Sleep Apnea undergoing adenotonsillectomy may achieve the same efficacy of fentanyl with less respiratory complications and less opioid-related side effects.

Two Post-Operative Pain Protocols at Discharge for Orthopaedic Patients

This is a single-center, pilot randomized controlled trial designed to evaluate the feasibility of a definitive trial comparing opioid-free discharge prescriptions to usual care (which includes opioids) in patients undergoing major orthopaedic surgery. The main objective is to inform the design and feasibility of the definitive RCT.

Acute Preoperative Pain and Chronic Post-surgical Pain in Emergency Surgery

Studies evaluating postoperative pain as a risk factor for CPSP are almost exclusively carried out in the context of scheduled surgery. As a result, the preoperative pain studied as a risk factor for chronicity is essentially a state of pain that has persisted for several weeks or even several months. In emergency surgeries, patients are subject to acute preoperative pain of varying intensity and the duration of which may vary by a few days. A few studies have highlighted the intensity of acute preoperative pain as a factor favouring moderate to severe postoperative pain. At this point, no study has addressed the long-term consequences of this intense preoperative pain the emergency context. An evaluation in the field of emergency surgery, where the preoperative pain is often intense and limited in time, would enable us to identify more precisely the impact of acute pain on the incidence of CPSP. The investigators are hypothesising that the occurrence of CPSP at 3 months in patients undergoing emergency orthopaedic or abdominal surgery is associated with acute preoperative pain.

Opioid Consumption After Thoracotomy and Factors Affecting Postoperative Acute Pain

Thoracic surgery operations constitute a significant portion of surgical procedures performed in hospitals. In the United States, more than 50,000 thoracic surgical procedures are performed annually, and more than 80% of these patients experience moderate to severe postoperative pain requiring opioid administration, which increases the risk of complications . It has also been reported that chronic pain develops in approximately 50% of patients after thoracic surgery . Thoracic surgery is commonly associated with severe, multifactorial pain during the postoperative period and is among the surgical branches with a high risk of developing chronic pain Despite advances in understanding postoperative pain mechanisms and improvements in pain management, inadequate postoperative pain control remains an unresolved healthcare problem. Higher acute pain scores are associated with less effective ventilation and coughing, increased incidence of lower respiratory tract infections, and prolonged ICU and hospital stays . In the management of acute postoperative pain after thoracic surgery, clinicians have sought alternatives to thoracic epidural analgesia to avoid its potential adverse effects. Truncal blocks such as thoracic paravertebral block, erector spinae plane block, and serratus anterior block have been used to reduce postoperative pain . Additionally, various other analgesic techniques such as patient-controlled analgesia (PCA) and multimodal analgesia have been employed. Historically, the cornerstone of acute postoperative pain control has been systemic opioids administered via oral, intravenous, or thoracic epidural routes . Although opioids provide excellent pain relief, they are associated with significant side effects that can adversely affect recovery . With the increasing use of ultrasonography (USG), truncal blocks have become more widespread. Alongside the development of Enhanced Recovery After Thoracic Surgery (ERATS) protocols, efforts have been made to reduce opioid use, leading to differing opinions regarding the management of acute pain after thoracic surgery. To prevent opioid use disorder and potential side effects, opioid-free or opioid-sparing approaches are now being encouraged in perioperative pain management . Conversely, some studies suggest that intraoperative opioid administration may have favorable effects on postoperative acute and chronic pain. Previous research has reported that the average daily opioid consumption after thoracic surgery is approximately 30 morphine milligram equivalents (MME) . Although video-assisted thoracoscopic surgery (VATS) has become more common, thoracotomy cases still constitute a large proportion of thoracic surgery procedures. Moreover, severe postoperative pain after thoracic surgery is most commonly associated with the thoracotomy incision itself. While some studies have suggested that new truncal block techniques may provide effective analgesia and reduce opioid consumption after thoracotomy, further studies are needed to determine which blocks are most commonly preferred and how opioid consumption patterns have changed with the adoption of these newer regional techniques. A review of the current literature reveals that the factors influencing acute pain after thoracotomy have not been sufficiently evaluated. Therefore, a re-evaluation of the factors affecting acute pain following thoracotomy, considering recent developments in pain management, is necessary. Furthermore, examining the relationship between perioperative opioid consumption, postoperative complications, and hospital length of stay in this patient population will provide valuable contributions to the literature. The aim of this study is to evaluate the amount of opioid consumption following thoracotomy and to investigate whether perioperative opioid use affects acute pain, postoperative complications, and the length of hospital stay.

Impact Evaluation of the Therapeutic Initiative's Prescribing Portrait and Therapeutics Letter on Opioid Use by Dentists

The aim of this study is to estimate the impact of providing personalized prescribing data and educational materials on opioid prescribing to dentists in British Columbia, Canada. The main research questions are: 1. What is the impact of an intervention on the use of opioids for dental pain? The intervention includes a personalized prescribing report (a "Portrait"), brief educational summary, and patient education materials; and 2. Does the impact of the intervention increase when dentists are also invited to attend facilitated audit-and-feedback group sessions and to develop a practice improvement plan? Using administrative health data, the prescribing of those in different combinations of materials in the Early Group will be compared to those in the Delayed Group to estimate the impact of the materials on prescribing by the dentists.

Study on the Relationship Between Opioid Drugs and the Therapeutic Efficacy of Immunotherapy

Relationship between pain and the efficacy of immunotherapy: Does the degree of pain control affect the therapeutic efficacy of ICIs? Does the use of opioid drugs independently affect the efficacy of immunotherapy?

Erector Spinae Block in Reducing Peri-operative Opioid Consumption in Total Abdominal Hystrectomy

Hystrectomy is a surgical procedure that involves removal of uterus from the body of patient using a lower abdominal incision. This is an extremely painful procedure which causes discomfort and greatly increases opioids consumption in the peri-operative period. This can be reduced by using nerve blocks such as Erector spinae plane block.

GLP-1R Agonist Treatment for Opioid Use Disorder

The goal of this clinical trial is to learn if semaglutide can reduce illicit opioid use in adults in outpatient treatment for opioid use disorder, and who are receiving either buprenorphine or methadone maintenance treatment. The main question it aims to answer is: • Does semaglutide increase the likelihood that participants will refrain from using illicit and nonprescribed opioids? The investigators will compare semaglutide to a placebo (a needle prick that contains no drug) to see if semaglutide works to reduce use of illicit and nonprescribed opioids. The participants will: * Take semaglutide or a placebo every week for 12 weeks * Visit the clinic every week for urine drug screening and pregnancy testing, vital signs, and to complete mental health and drug use questionnaires * Complete smartphone surveys sent at set times during the study

The Effect of Opioid Free Anesthesia Using Ultrasound-Guided Bilateral Transversus Abdominus Plane Block and Dexmedetomidine Infusion

This study aimed to determine the effects of Opioid-free anesthesia using dexmedetomidine and bilateral Transversus abdominis plane block on the quality of recovery, incidence of Opioid-free anesthesia, and post-operative pain and delirium in morbid obese patients undergoing gynecological surgeries.

Perioperative Analgesia Modes in Minimally Invasive Esophagectomy

This study was designed to compare analgesic efficacy and safety of different perioperative analgesic modes in minimally invasive esophagectomy for esophageal cancer.

Low-Dose Ketamine Infusion During Burn Wound Care

The current standard of care (SOC) (i.e. fentanyl and midazolam) offers limited efficacy for preventing or relieving pain. Ketamine infusions may provide the benefits of analgesia, minimize adverse events, and reduce opioid use. The purpose of this study is to determine if adding a low dose ketamine infusion during wound care will safely provide pain relief for patients with burn injury.

Role of High Frequency RTMS in Management of Opioid Use Disorder

This study aims to evaluate the role of repetitive Transcranial Magnetic Stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (DLPFC) in reducing pain, decreasing craving, alleviating withdrawal symptoms, lowering relapse rates, reducing impulsivity, and improving cognitive function in patients with Opioid Use Disorder, while also evaluating associated factors.