Clinical Research Directory

Comparison of Analgesic Effects of ACB Versus ACB Combined With BiFeS Block in Meniscopathy Surgery

Meniscopathy surgeries are commonly associated with moderate postoperative pain, particularly during early mobilization and rehabilitation. Inadequate postoperative analgesia may negatively affect functional recovery, delay ambulation, increase opioid consumption, and contribute to opioid-related adverse effects. Therefore, effective multimodal analgesic strategies are of considerable importance in patients undergoing arthroscopic knee procedures. Adductor canal block (ACB) is a widely used regional anesthesia technique that provides effective analgesia while largely preserving quadriceps muscle strength. However, its limited effect on posterior knee capsule innervation may result in insufficient control of posterior knee pain. Recently, the biceps femoris short head (BiFeS) block has been described as a novel motor-sparing fascial plane block targeting the posterolateral knee capsule and may provide additional analgesic benefit when combined with ACB. In this study, it was aimed to compare the postoperative analgesic efficacy of adductor canal block alone and adductor canal block combined with BiFeS block in patients undergoing surgery for meniscopathy.

Recto-intercostal Fascial Plane Block in Cholecystectomy

This study aims to evaluate whether an ultrasound-guided recto-intercostal fascial plane block performed before surgical incision in patients undergoing laparoscopic cholecystectomy reduces intraoperative opioid and volatile anesthetic consumption. Additionally, the study assesses its effects on postoperative pain and the incidence of nausea and vomiting.

Study of Nerve Injuries and Physical Exercise

This study will explore if combining exercise with sensory training can help improve sensory function and reduce pain after an injury to the nerves in the arm and hand. The study will look at how exercise affects the BDNF protein (which helps nerves grow), how it impacts sensation, and how it might help manage pain. Research has shown that exercise is good for brain health, enhancing abilities such as focus, memory, and the ability to cope with stress. It also helps the brain release BDNF, which helps nerve cell growth and plasticity. Higher levels of BDNF might improve sensory function, but no previous study has investigated the combination of exercise and sensory training. Study aims to investigate: * if it is possible to use a physical exercise program (using an exercise bike) for people with nerve injuries. * how easy it is to recruit participants, how well they stick to the program * if exercise can change BDNF levels and VO2max (a measure of fitness), and how these changes might relate to pain and sensory. * if it's possible to run a bigger, more detailed study in the future and check if it could be helpful for patients. The researchers believe that combining exercise with sensory training could help reduce pain and improve sensation compared to traditional sensory training methods. Participants will: * perform 30 minutes of exercise on a stationary bike, twice a week, for 6 weeks at a moderate level of effort. After the exercise, they will do 5-10 minutes of sensory training, with additional exercises to practice at home. The sensory training will follow a standard program designed to help retrain the brain to process sensory information. * be subject to a blood sample Results will include sensory function, pain evaluation, patient reported outcome measures.

Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy

The objective of this study is to conduct a randomized clinical trial to evaluate an opioid versus an opioid-free pathway of perioperative use of ketamine, ketorolac, and IV acetaminophen followed by the postoperative use of ketorolac, and oral acetaminophen for pain associated with robotic-assisted radical prostatectomy. Escalation to use of opioid treatment for the opioid-free constituents will be available if needed.

External Oblique Intercostal Block vs Erector Spinae Plane Block for Postoperative Analgesia After Laparoscopic Cholecystectomy

This randomized controlled study aims to compare the effects of the external oblique intercostal block (EOIB) and the erector spinae plane block (ESPB) on postoperative analgesia in adult patients undergoing elective laparoscopic cholecystectomy. Both EOIB and ESPB are ultrasound-guided regional anesthesia techniques currently used in clinical practice to improve postoperative pain control as part of multimodal analgesia strategies. Laparoscopic cholecystectomy is a common minimally invasive surgical procedure; however, patients may still experience postoperative pain that can increase opioid consumption and delay recovery. Identifying the most effective regional anesthesia technique may improve postoperative analgesia and patient recovery. In this study, eligible patients will be randomly assigned to receive either bilateral EOIB or bilateral ESPB in addition to standardized general anesthesia and postoperative patient-controlled analgesia. Postoperative pain scores, opioid consumption, quality of recovery, postoperative nausea and vomiting, and block-related complications will be evaluated during the first 24 hours after surgery. The study aims to provide comparative clinical evidence regarding the analgesic effectiveness of these two regional anesthesia techniques.

Comparison of Cumulative Opioid Consumption Between Variable-Rate Feedback Infusion and Fixed-Rate Basal Infusion Modes of Intravenous PCA Following Mixed Surgery

Perioperative pain management affects patient recovery. However, the rate of moderate to severe postoperative pain is as high as 73.8%, which hinders recovery and increases the risk of complications. Although opioids are the first-line analgesics, excessive use leads to adverse reactions. The traditional fixed-rate PCA mode is difficult to match the changes in postoperative pain. This study will compare different PCA mode optimization strategies, assuming that they can reduce opioid dosage, improve analgesic effect, and reduce adverse reactions, providing high-quality evidence-based basis for postoperative analgesia and promoting individualized and intelligent management.

Evaluation of Paro, a Therapeutic Assistance Robot in Analgesic Management During the Placement of a Peripheral Intravenous Line in Infants and Children.

Peripheral intravenous catheterization is one of the most frequently performed procedures in pediatric emergency departments and hospital units. It is often associated with significant anxiety in both children and their parents, which may exacerbate the pain experienced during the procedure, as fear and pain are closely interrelated. Effective management of pain and anxiety is therefore essential to optimize the child's well-being in the short, medium, and long term. The quality of pediatric analgesia relies on a multimodal approach combining pharmacological and non-pharmacological interventions. In recent years, several non-pharmacological strategies have been developed to reduce pain and anxiety. Among these, innovative technologies such as therapeutic assistance robots incorporating artificial intelligence have emerged; however, their clinical benefits remain to be established. The present study aims to evaluate the effectiveness of PARO, a therapeutic assistance robot designed in the form of a baby seal, in the management of pain during peripheral intravenous catheterization in children. The investigators will compare the effects of PARO in combination with standard care versus standard care alone during needle-related procedures. The primary objective is to determine whether the use of this device improves pain management in children undergoing skin puncture. This study is designed as a multicenter, randomized, open-label, superiority trial conducted across five pediatric centers. A total of 120 infants and children aged 12 months to 7 years undergoing peripheral intravenous catheterization will be enrolled. Pain will be assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) observational scale, which is validated for this age group. Secondary objectives include the assessment and comparison of procedural distress between groups using the PRIC (Procedural Restraint Intensity in Children) score, evaluation of heart rate variability, number of catheterization attempts, parental anxiety measured by the STAI (State-Trait Anxiety Inventory), and satisfaction levels among both parents and healthcare staff.

Virtual Reality-Assisted Nursing Intervention During Intrauterine Device Insertion

Effect of Virtual Reality-Assisted Nursing Intervention on Pain and Anxiety During Intrauterine Device Insertion: A Randomized Controlled Trial April 30, 2026 The aim of this study was to evaluate the effect of a virtual reality-assisted nursing intervention on participants' pain, anxiety, physiological parameters and comfort levels during Intrauterine Device (IUD) insertion. In this context, the study which hypothesises that the virtual reality application will reduce pain and anxiety during the procedure, support physiological stability, and enhance participants' comfort levels was designed as a randomised controlled trial.

Patients With Pancreatic Tumor: Use of an App to Monitor Progress in a Simple and Intuitive Way by Periodically Completing Targeted Questionnaires and Providing Educational and Informational Content (PancreasPlus).

Caring for people with pancreatic cancer requires good coordination between hospital care and care at home, with different healthcare professionals working closely together. Patients are also becoming more involved in managing their own care on a daily basis. However, this active involvement can be difficult if there is poor communication with healthcare teams, differences in skills or familiarity with digital tools, or systems that do not support patient participation. The PancreasPlus app was developed to support patients and caregivers by providing reliable information, self-monitoring tools, and a communication channel with healthcare professionals. The study aims to assess the feasibility, patient engagement, and perceived quality of routine use of the app. It is hypothesized that its use will improve engagement, perceived quality, reduce anxiety and unplanned hospital visits, without introducing technological or privacy risks. The app supports information and data collection but does not replace clinical decision-making. Objectives Primary objectives: Assess feasibility and patient engagement through questionnaire completion. Evaluate perceived service quality using the Client Satisfaction Questionnaire (CSQ-8). Secondary objectives: Monitor unplanned hospital visits and adherence to chemotherapy. Assess anxiety (HADS-A), nutritional status, and global quality of life (PROMIS Global). Evaluate usability and acceptability of the app (SUS, UTAUT2 short version). Endpoints Primary endpoints include questionnaire completion rates and perceived quality (CSQ-8 score). Secondary endpoints include unplanned hospital access, chemotherapy adherence, anxiety levels, nutritional status, quality of life, and app usability/acceptability. Methods This is a prospective, interventional, multicenter study with consecutive enrollment of eligible patients. Each participant will be followed for 3 months, with most activities conducted remotely via the app. At baseline (T0), patients receive study information, provide consent, undergo training, register in the app, and complete initial assessments (clinical, socio-demographic, PROMIS Global, HADS-A). At 12 weeks (W12), follow-up includes all outcome questionnaires and data on unplanned hospital visits. The app includes features such as a personal diary (symptoms, weight, BMI, appointments), interactive questionnaires with tailored feedback, and educational content on nutrition, prevention, emotional support, and patient rights. Population Inclusion criteria: adults (≥18 years) with pancreatic cancer, access to a smartphone/tablet (or caregiver support), ability to consent, and understanding of Italian. Exclusion criteria include severe cognitive impairment, inability to use the app or complete follow-up, or withdrawal of consent. Sample Size and Analysis A total of 185 patients will be enrolled (accounting for 10% dropout), based on an expected 70% engagement rate. Analyses will be conducted on both intention-to-observe and per-protocol populations. Engagement will be analyzed as questionnaire completion rates, while other outcomes will be analyzed using appropriate statistical models (e.g., logistic regression, ANCOVA, descriptive statistics). An interim analysis at 50% enrollment is planned to address potential low engagement.

Retroclavicular Block in Vascular Surgey

The retroclavicular (coracoid) approach for brachial plexus anesthesia is recognized for its facility and simplicity to perform . The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig . first described the block's use in the ED setting for a variety of indications . Because of its different needle entry point, the retro clavicular (RCB) approach offers an almost perpendicular needle-ultrasound (US) beam angle.

Life-Style Medicine for Chronic Musculoskeletal Pain in Older People

The goal of this clinical trial is to determine the clinical effectiveness of lifestyle medicine in reducing chronic musculoskeletal pain in older adults, as measured by pain intensity, pain interference, self-management efficacy, stress level, sleep quality, healthier diet, better quality of life, and cost-effectiveness, compared to a waitlist control group. Participants will be randomly assigned to either the intervention or the waitlist group. The intervention group will meet the health coach face-to-face for four sessions to negotiate and set personalized health goals. The waitlist control group will continue to receive usual care without any additional intervention for 24 weeks. Both groups will complete three assessments: at the start of the study, one month after the intervention, and three months after the intervention. The waitlist control group will be offered the same intervention after completing the study.

Rectroclavicular Block in Orthopedic Surgey

The ultrasound-guided retroclavicular approach to the infraclavicular region (RAPTIR) brachial plexus block has gained popularity as a relatively easy-to-perform nerve block that provides reliable and dense anesthesia to the upper extremity with a single injection. The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig first described the block's use in the ED setting for a variety of indications . This nerve block has classically been described to provide extensive anesthesia for procedures distal to the shoulder, such as elbow dislocations, distal radius fractures, and surgical procedures.

Dexmedetomidine in Postoperative Analgesia

There is a high incidence reaching up to 45%; of severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery, which is often significant enough to interfere with initial recovery and rehabilitation.Various peripheral nerve blocks have been used to reduce intraoperative anesthetic requirements to improve rapid recovery and reduce postoperative pain.

Virtual Reality as a Method for Pain and Anxiety Control During First Trimester Procedural Abortion

The goal of this clinical trial is to learn whether use of a virtual reality (VR) headset showing a meditative nature video will help reduce pain and anxiety during a first trimester procedural abortion. Investigators will enroll 72 patients undergoing a first trimester procedural abortion with usual care to manage pain and anxiety compared to use of a VR headset in addition to usual care to see if use of the VR headset will decrease pain and anxiety and increase satisfaction with the procedure.

Dose-Response Effects of a Brief Audio-Guided Mindfulness Intervention for Acute Pain

This project is a single-site, three-arm, randomized controlled trial investigating whether different length audio-recorded mindfulness practices differentially decrease pain among patients in a waiting room awaiting orthopedic care.

Analgesic Consumption in the Early Postoperative Period: A Prospective Observational PACU Study

Postoperative pain remains a significant clinical challenge that directly affects patient recovery, functional outcomes, and overall quality of care. Inadequate pain control in the early postoperative period is associated with delayed mobilization, increased risk of complications, prolonged hospital stay, and the development of chronic pain. The post-anesthesia care unit (PACU) represents a critical phase in which pain is actively assessed and managed, and analgesic consumption during this period serves as an objective indicator of analgesic requirements and effectiveness of perioperative pain strategies. This prospective observational study aims to identify patient-related, surgical, and anesthesia-related factors influencing analgesic consumption in the early postoperative period among adult patients admitted to the PACU following elective surgery. No additional interventions will be performed, and all perioperative management will follow routine clinical practice. Data will be collected prospectively from clinical records, anesthesia charts, and PACU monitoring forms. The primary outcome is total analgesic consumption during the PACU stay. Secondary outcomes include pain intensity assessed using a standardized pain scale at PACU admission and discharge, requirement for rescue analgesia, incidence of postoperative nausea and vomiting, and length of stay in the PACU. The findings of this study are expected to contribute to the identification of patients at higher risk for increased analgesic requirements and to support the development of individualized pain management strategies, ultimately improving perioperative care quality and patient outcomes.

Efficacy and Safety of Etoricoxib+Diacerein in Osteoarthritis.

The goal of this clinical trial is to learn if fixed-dose combination etoricoxib 90 mg + diacerein 50 mg capsule works to treat knee/hip osteoarthritis-associated pain in adults. It will also learn about the safety of the drug. The main questions it aims to answer are: Does etoricoxib+diacerein reduce pain intensity as per WOMAC scale after 60 days? What medical problems do participants have when taking etoricoxib 90 mg+diacerein 50 mg capsule for 60 days? Researchers will compare the test drug etoricoxib 90 mg+diacerein 50 mg capsule to an active comparator (meloxicam 15 mg + diacereina 50 mg) to see if drug ABC works to treat pain in patients with osteoarthritis. Participants will: Take drug the test or comparator drugs every day for 60 days. Visit the clinic once a month for health and outcomes follow-up. Keep a diary of their symptoms, pain intensity, WOMAC scale, adverse events, rescue medication use, other used drugs, and treatment adherence.

Aerobic Exercise and Its Impact on Sensory, Musculoskeletal, and Psychosocial Aspects in Migraine

Migraine is a neurological disorder associated with high levels of disability and changes in sensory processing, musculoskeletal function, and psychosocial factors. Aerobic exercise is a low-cost, non-pharmacological strategy that has shown potential benefits for migraine management, but its effects on sensory perception and musculoskeletal function are not yet fully understood. This randomized controlled trial will investigate the effects of a supervised aerobic exercise program combined with pain neuroscience education compared with an active control condition in women aged 18 to 48 years diagnosed with migraine. Participants will be randomly allocated to either an intervention group, which will perform supervised aerobic exercise three times per week for 16 weeks and receive one session of pain neuroscience education, or a control group, which will receive recommendations for unsupervised physical activity at home. Outcomes related to migraine-related disability, self-reported symptoms, sensory sensitivity, and musculoskeletal function will be assessed at baseline and after the intervention period. Questionnaires will also be collected at a 6-month follow-up. The results of this study may contribute to the development of accessible and low-risk non-pharmacological treatment strategies for people with migraine.

Management of Moderate to Severe Monotraumatic Pain With Sublingual Sufentanil in an Emergency Situation.

Pain is a common reason for emergency department (ED) visits. However, studies suggest that emergency physicians may not always provide optimal analgesic treatment due to various factors, such as time constraints, demographic factors like gender and age, and concerns about opioid use. As a result, patients with moderate to severe pain often experience long delays before receiving analgesia and may even be discharged with unresolved pain or suboptimal treatment. Additionally, diagnostic procedures for patients with isolated trauma (e.g., clinical examinations, radiographs) can lead to variations in pain levels, making it difficult to assess the effectiveness of analgesia. A commonly used treatment for moderate to severe pain is intravenous opioid administration. However, this approach requires longer wait times, complex titration, and significant resources (beds, nurses, equipment), which may be limited during peak hours. While oral opioids require fewer resources, their delayed onset and limited titratability restrict their use for severe pain. The sublingual sufentanil tablet (30 mcg), delivered via a single-dose applicator, was developed for patients with moderate to severe pain in emergency or outpatient surgical settings. Its unique pharmacokinetic and pharmacodynamic properties could offer advantages in non-invasive acute pain management. Sublingual sufentanil received market authorization in June 2018 for the treatment of moderate to severe acute pain in adults and is already used in many hospitals. However, further studies are needed to confirm its effectiveness and potential superiority in pain management. The objective of this study is to evaluate the effectiveness of 30 mcg sublingual sufentanil in patients admitted for moderate to severe pain due to isolated trauma. This will be compared to the standard pain management protocol used in the Clermont-Ferrand emergency department, focusing on pain score variations using a numerical rating scale (0-10)

Effect Of Game-Based Breathing Exercise On Pain, Fear, And Anxiety In Children During Venipuncture

Venipuncture is one of the most common invasive procedures in children and is often associated with significant pain, fear, and anxiety.This randomized controlled study will aim to evaluate the effects of a video game-based breathing exercise intervention on pain, fear, and anxiety levels in children aged 7-12 years undergoing routine venipuncture. While the intervention group will receive a video game-based breathing exercise using the BREATHING+ system in addition to standard care, the control group will receive routine venipuncture procedures only. The study population will consist of children aged 7-12 years who meet the inclusion criteria and whose parents/legal guardians provide informed consent. Participants will be randomly assigned to intervention and control groups. Pain, fear, and anxiety levels will be assessed at three time points: before the procedure, during the procedure, and immediately after the procedure. Data will be collected using the Visual Analog Scale (VAS), Children's Anxiety Scale-State (CAS-S), and Children's Fear Scale (CFS), along with a structured questionnaire form. All assessments will be conducted at the predefined time points.

Quality of Life and Functional Outcomes in Laryngeal Cancer Patients

Laryngeal squamous cell carcinomas are head and neck malignancies that directly affect both swallowing and voice functions and are associated with a significant deterioration in patients' quality of life throughout the treatment process. The aim of this study is to evaluate quality of life, voice and swallowing functions, pain, anxiety-depression levels, and patient satisfaction at the pre-treatment period and at the 3rd, 6th, and 12th months post-treatment in patients with laryngeal malignancies, using validated questionnaires, in order to: Elucidate the course of functional recovery following treatment, Individualize rehabilitation and follow-up strategies, and Examine the relationship between functional outcomes and oncological survival.

Solving SCI Pain: Pain Recovery Tools for SCI

Brief Summary The goal of this clinical trial is to evaluate whether a neuroscience-informed, peer-led self-management program can promote behavior change and reduce pain interference in adults with spinal cord injury (SCI) and chronic pain. The primary aim is to support participants in developing practical, sustainable strategies for managing chronic pain through education, reflection, and consistent application of self-management tools. The program is designed to shift participants from passive recipients of care to active agents in their own pain management process. Chronic pain is highly prevalent among individuals with SCI, and many report that traditional treatments - primarily pharmacological - provide limited relief and are accompanied by significant side effects. There is a growing need for accessible, non-clinical interventions that empower individuals to manage pain based on the latest neuroscience and behavior change principles. Solving SCI Pain intervention is a 7-week, multi-component program grounded in brain-based pain science, neuroplasticity, and behavior change models. The main questions it aims to answer are: * Does the intervention lead to meaningful changes in behavior that support pain self-management? * Does it reduce pain interference in everyday life? Participants will: * Attend three 2-hour group education sessions focused on the neuroscience of pain, the role of fear-avoidance, pain-related beliefs, and body-based self-regulation tools (e.g., movement, Graston, percussion massage, and red light therapy). * Participate in four individual coaching sessions (up to 1 hour each) designed to help them reflect on their experiences, overcome barriers, and integrate the tools into daily life. * Follow individualized coaching recommendations and provided resources to support each participant's unique engagement with cognitive and body-based tools over the 7-week period, including light journaling, goal setting, and guided reflections. * Complete brief check-ins every four days to monitor progress, engagement, and self-reported outcomes. Group and coaching sessions will be recorded and transcribed to support qualitative analysis, allowing researchers to understand how the intervention is experienced and delivered. This will help refine the program for future implementation and scaling. The study prioritizes accessibility, relevance, and peer involvement to address the real-world needs of individuals living with SCI and chronic pain.

Opioid-Sparing Joint Replacement

The goal of this clinical trial is to evaluate whether an opioid-sparing postoperative pain regimen can reduce opioid consumption and maintain effective pain control in adults undergoing anterior total hip arthroplasty for osteoarthritis. The main questions it aims to answer are: * Does an opioid-limited regimen result in lower postoperative opioid use compared with a standard opioid prescription? * Does the opioid-limited regimen provide comparable or improved postoperative pain control and patient satisfaction?

Effects of S-ketamine on Perioperative Opioid Consumption

This study is a triple-blind randomized controlled trial conducted at a tertiary care hospital in Brussels. It investigates whether a single dose of S-ketamine can reduce opioid (morphine) consumption in the first 24 hours after elective laparoscopic gynecological surgery in relatively healthy adult patients (ASA 1-2). The goal is to assess S-ketamine's effectiveness within a standardized postoperative pain management protocol.