Clinical Research Directory

A Study Evaluating Efficacy and Safety of VX-993 for Acute Pain After a Bunionectomy

The purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of VX-993 in treating acute pain after a bunionectomy.

Comparison of IV Analgesia Protocols After the Regional Block's Effect Diminishes in Thoracic Surgery

The purpose of this study is to compare the effectiveness of three different intravenous (IV) patient-controlled analgesia (PCA) regimens-Fentanyl, Tramadol, and Ibuprofen-in managing postoperative pain and respiratory performance in patients undergoing Video-Assisted Thoracoscopic Surgery (VATS). While regional blocks like Erector Spinae Plane (ESP) block provide effective early analgesia, their effect typically diminishes after 8-12 hours, leading to potential 'rebound pain.' This study specifically investigates the period following the duration of the regional block's action. The primary goal is to evaluate which IV PCA protocol better controls pain (Visual Analog Scale scores) and supports better respiratory performance (measured by incentive spirometry) during the first 72 hours post-surgery

Understanding the Acute Pain Phenotype in Patients Undergoing Surgery

The goal of this observational study is to learn about how regional anesthesia (numbing medication) affects pain in patients with different psychosocial phenotypes such as different levels of concern about pain, sleep issues, and anxiety, who are having surgery. The main questions are: 1. Do psychosocial factors such as concerns about pain, sleep, anxiety affect the effectiveness of regional anesthesia? 2. Do psychosocial factors and regional anesthesia affect the amount of opioids used after surgery? 3. Do psychosocial factors and regional anesthesia affect development of chronic postsurgical pain?

ESKetamine Low-dose vs Ketamine Low-dose for Severe Acute Pain in Emergency Units, Comparison of PsychodyslEptic Effects

Almost 30% of painful patients in emergency departments (ED) describe their pain as severe (i.e. a Verbal Numerical Rating Score VNRS ≥ 6 on a scale ranging from 0 to 10). The management of such severe pain needs to be rapid and safe, and for this purpose intravenous (IV) morphine titration is still the gold-standard. However, morphine titration takes up considerable caregiver time, as patients need to be monitored and treated progressively with small quantities of morphine every 5 minutes until analgesia. This is sometimes difficult to reconcile with a saturating flow of patients, and overcrowding in ED is proven to significantly delay time-to-analgesia, and even lead to deleterious under-treatment. Finally, the opioid crisis is a major concern, explaining why strategies are being advocated to develop other ways of managing severe acute pain in the ED and to limit the use of opioids. Recent studies show that ketamine administered in small IV doses ("low-dose" ketamine LDK: 0.2 to 0.3 mg/kg) possesses potent analgesic activity as well as interesting anti-hyperalgesic and anti-allodynic properties. Compared with morphine, LDK does not induce respiratory depression, but can sometimes induce disturbing psychodysleptic effects. These may include a sensation of unreality, fatigue, anxiety, dizziness or hallucinations. According to studies, 30-80% of LDK-treated patients experience psychodysleptic effects. However, two recent studies suggest that slow IV injections of LDK (over 10 minutes) may improve patient tolerance, although these slow infusions do not totally reduce this discomfort. Pharmacologically, ketamine is a racemic mixture of 2 isomers: esketamine S(+), which is dextrorotatory, and arketamine R(-), which is levorotatory. In recent years, a new formulation containing only esketamine has been made available to hospitals in some northern European countries, and more recently in France. Esketamine appears to have twice the analgesic efficacy of racemic ketamine, and studies on healthy volunteers or in peri-operative settings suggest that it is also better tolerated psychologically than ketamine. For the moment, however, scientific data are lacking, and no comparative trial has yet been conducted in the ED setting. The investigators plan to conduct in their ED a prospective, single-center, randomized, double-blind study aiming to compare the tolerance and efficacy of esketamine versus racemic LDK in patients presenting with severe acute pain (VNRS ≥ 6/10).

Continuous Adductor Canal Block in Outpatient Total Knee Arthroplasty

Total knee arthroplasty (TKA) is a frequent performed surgery. Many institutions are implementing outpatient programs for this surgery and adequate pain management is an important feature. Analgesic duration of single shot nerve blocks is limited to no more than 24h. Conversely, the use of continuous nerve block (CNB) through a perineural catheter and infusion of local anesthetic may increase duration of analgesia and provide better outcomes. The purpose of this study is to evaluate effectiveness and safety of using CNB in patients undergoing primary TKA, and its effects on patients' quality of recovery. We hypothesize that continuous adductor canal block would lead to a better quality of recovery in patients undergoing primary TKA.

Efficacy and Safety of High-Concentration 35 kDa Hyaluronan Gel for Herpes Zoster-Associated Pain

This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of topical 10% high-concentration 35 kDa hyaluronan (HA35) gel in subjects with herpes zoster-associated pain (ZAP). Eligible participants will receive a single topical application of the study gel. The primary objective is to assess rapid pain reduction within 2 minutes and 24hours after application. Secondary objectives include evaluation of analgesic duration, local tolerability, erythema improvement, and overall safety throughout the observation period. This is a minimal-risk, non-pharmacological supportive care intervention.

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.

A Study of LY4515100 in Participants With Pain Following Third Molar Removal

The purpose of this study is to evaluate the safety and efficacy of LY4515100 and see how a single oral dose compares with placebo in acute postsurgical pain after removing impacted third molars. For each participant, the study may last approximately 6 weeks and will include a stay in a Clinical Research Unit (CRU) after third molar removal.

The Role of NaV1.8 in Human Pain Models

This study aims to understand how NaV1.8, a specific type of sodium channel found in peripheral nerves, contributes to different types of pain in humans. To address this, suzetrigine, a highly selective blocker of the NaV1.8 channel, is used. While current pain medications often have side effects that limit their use, NaV1.8 is a promising target for new, non-opioid pain treatments because it is primarily located in the nerves that send pain signals to the brain. This study is a randomised, placebo-controlled double-blind crossover microdosing trial. This means that very small, safe amounts of the drug are injected directly into the skin of healthy volunteers to observe its effects locally. This approach ensures the drug works only at the injection site with negligible exposure to the rest of the body. Healthy volunteers will undergo six different types of brief, controlled pain tests to see which ones are reduced by blocking NaV1.8. These tests are as follows: * Electrical stimulation: Brief electrical pulses delivered onto the skin. * Mechanical stimulation: A standardised "pin-prick" stimulation of the skin. * Chemical stimulation: An injection of fluid containing capsaicin (the active component of chilli peppers) superficially into the skin. * Heat stimulation: An injection of hot fluid superficially into the skin. * Cold stimulation: An injection of cold fluid superficially into the skin. * Acid stimulation: An injection of acidic fluid superficially into the skin. By comparing the effects of suzetrigine against a placebo and a standard local anaesthetic (lidocaine), the study will help determine which specific pain modalities critically depend on NaV1.8.

Retrospective Analysis of Pain After Nerve Block in Surgical Patients

This is a retrospective study looking at patients who received a nerve block for surgery and assessing pain after the nerve block resolves, with or without an educational intervention, over two periods of time.

Comparing the Postoperative Analgesic Efficacy of Anterior Iliac Block and Ilioinguinal-iliohypogastric Block in Inguinal Hernia Surgery

The primary aim of this study is to compare two postoperative analgesia techniques used in patients undergoing inguinal hernia surgery-(1) the anterior iliac block and (2) the ilioinguinal/iliohypogastric block-in terms of postoperative analgesia duration and patient satisfaction. Effective postoperative analgesia in inguinal hernia surgery is crucial for improving patient comfort and reducing opioid consumption. Although ilioinguinal and iliohypogastric nerve blocks are commonly used for this purpose, their relatively limited dermatomal coverage may result in inadequate analgesia in some cases. The recently described Anterior Iliac Block has been proposed as an alternative to conventional techniques, offering potentially wider neural spread and more effective postoperative pain control. However, the efficacy and safety of this novel block have not yet been sufficiently evaluated in the literature.

The Implementation of a Post-operative Communication App to Improve Pain Control and Opioid Use

Digital communication tools are becoming ubiquitous in healthcare, though their impact on patient/provider communication, healthcare utilization, and outcomes remains poorly established. M Health Fairview (MHFV) in collaboration with the Center for Learning Health System Sciences (CLHSS) Rapid Eval team will be evaluating one such communication application: OPY, which leverages the Epic-Care Companion functionality to remove barriers in communicating with the patient's care team. This project will evaluate the effectiveness of a digital, post-operative patient engagement tool (Epic-Care Companion made available through MyChart), OPY, which has the goal of preventing patients from becoming addicted to opioids or to suffer from opioid misuse or diversion. In the proposed pragmatic trial, standard care with education available in MyChart and the patient after visit summary will be augmented by OPY. OPY is available to patients starting the same day they go home from surgery with a new opioid prescription. OPY provides a daily interactive experience that collects patient pain and side-effect information, provides advice for pain management, and uses behavioral "nudges" to encourage timely weaning and responsible disposal of opioid medications. The primary goal of this project is to evaluate the effect of two versions of OPY on measures of opiate use relative to the standard of care in a pragmatic randomized controlled trial.

Effects of Breastfeeding, Virtual Reality, and Stress Ball on Pain, Anxiety, Cortisol Levels, and Comfort During Episiotomy Repair

The goal of this clinical trial is to learn about the effects of three different interventions-breastfeeding, using a stress ball, or wearing virtual reality (VR) goggles-on pain, anxiety, and stress during episiotomy repair (stitching) after childbirth. It also aims to examine how these methods affect a mother's comfort after the procedure. The main questions it aims to answer are: Does breastfeeding, using a stress ball, or using VR goggles lower the mother's pain and anxiety during the repair? Do these interventions reduce the mother's biological stress levels, measured by saliva cortisol tests? Do these methods lead to higher postpartum comfort levels for the mother in the first 24 hours after birth? Researcher will compare these three intervention groups to a "control group" (mothers receiving standard hospital care) to see which approach is most effective. Participants will: Be randomly assigned to one of four groups: Breastfeeding, VR Goggles, Stress Ball, or Standard Care. Use their assigned intervention throughout the entire episiotomy repair process. Provide saliva samples before and after the procedure to measure stress hormones (cortisol). Rate their pain and anxiety levels using clinical scales twice: once before the procedure begins and once immediately after it is finished. Complete a survey about their comfort levels between 6 and 24 hours after the delivery.

Does Patient Testimonial Improve the Pain Relief Derived From a Brief Intervention

This project is a single-site, two-arm, randomized controlled trial investigating whether providing patients in an orthopedic clinic waiting room an audio-recorded mindfulness practice decreases their pain relative to an injury management control condition.

Little NIRVANA for Pediatric Pain and Anxiety

The aim of this study is to test the feasibility of using Little NIRVANA (augmented reality (AR)) for managing anxiety and pain for children 2-8 years old during hospital emergency peripheral intravenous (PIV) insertions. The investigators hypothesize that Little NIRVANA plus a numbing cream will reduce pain and anxiety for patients undergoing PIV placement in the emergency department (ED) when compared to the cream alone. It is anticipated that using the Little NIRVANA will not increase the ED length of stay, failed PIV placement attempts, or the need for additional intervention.

Virtual Reality Intervention to Reduce Pain in Women Undergoing Elective Oocyte Cryopreservation

This randomized controlled study evaluates whether exposure to relaxing virtual reality (VR) scenery prior to oocyte retrieval can reduce pain in women undergoing elective oocyte cryopreservation. Many women experience discomfort before and after oocyte retrieval. Virtual reality has been shown to reduce pain in various medical settings by providing distraction and relaxation. In this study, participants are randomly assigned to receive either routine care alone or routine care combined with a VR-based relaxation intervention while waiting for the procedure. Pain is assessed using validated questionnaires and standardized scales before and after oocyte retrieval. The results of this study may help determine whether VR can serve as a simple, safe, and non-pharmacological method to improve patient comfort during elective egg freezing.

Detection of Electrodermal Activity in Pain 1

The goal of this study is to investigate the association between self-reported pain and electrodermal activity and to develop an algorithm that detects pain-related changes in electrodermal activity in healthy volunteers undergoing a cold pressor test. The study is exploratory. The main research questions are: Can pain be detected using electrodermal activity, and do psychological variables, including stress, affect the electrodermal response to pain? Study Design: The study has two arms. Methodology: Thirty-seven healthy volunteers perform an experimental pain task while their electrodermal activity is recorded and complete questionnaires. The participants are randomized 1:1 to either the cold pressor test alone or the cold pressor test combined with a mild experimental stressor (Stroop task). Analysis: Discriminant analysis will be used to differentiate between mild, moderate, and severe pain levels. Secondary outcomes include assessing the influence of the mild stressor on the pain response. This study is exploratory, generating hypotheses for subsequent phases of the project.

Healthy Children and Virtual Reality Mediation of Simulated Pain

The objective of this study is to develop central nervous system (CNS) biomarkers of pain experienced during medical procedures and pain relief induced by Virtual Reality Pain Alleviation Therapy (VR-PAT). The study team plans to use innovative functional near-infrared spectroscopy (fNIRS) to identify and quantify the targeted CNS biomarkers. The ultimate goal of this project is to optimize the CNS biomarkers for predicting and/or monitoring response to virtual reality (VR)-based pain reduction approaches for pain management in clinical trials. 20 healthy children will be recruited for a 1-hour research visit where they will wear a blood pressure cuff to simulate pain and an fNIRS neuroimaging device while playing an immersive/engaging VR game, a passive VR video, and an iPad game.

Comparison of Erector Spinae Plane Block (ESPB) With the Combination of Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) in the Management of Postoperative Sternotomy Pain in Patients Undergoing Cardiac Surgery Via Sternotomy

This study aims to compare the effectiveness of two regional anesthesia techniques in managing pain for participants undergoing cardiac surgery via sternotomy. The investigators will evaluate whether the Erector Spinae Plane Block (ESPB) or a combination of the Superficial Parasternal Intercostal Plane Block (SPIPB) and Serratus Anterior Plane Block (SAPB) provides better pain control and recovery outcomes.

Acute Effects of LLLT on Pain Threshold and Pain Tolerance

Pain is defined by the International Association for the Study of Pain as "an unpleasant sensory and emotional experience associated with, or resembling that associated with, actual or potential tissue damage." Low-Level Laser Therapy (LLLT) has gained attention as a safe, noninvasive intervention with analgesic and anti-inflammatory effects. This study examines whether a single session of LLLT can produce immediate changes in pain threshold and pain tolerance in healthy adults, compared to a sham laser control.

Dexmedetomidine and Dexamethasone Added as Adjuvant Infraclavicular Brachial Plexus Block in Upper Limb Surgery

The aim of this study was to investigate the effect of dexmedetomidine and dexamethasone added during USG-guided infraclavicular block on block onset time, total block time and time to first analgesic need in patients undergoing upper extremity surgery.

Clinical Utility of the Numerical Verbal Scale (NVS) and the Pain and Functional Activity Scale (PFAS) in the Management of Rescue Analgesia in Acute Postoperative Pain. Randomized Study.

Adequate postoperative pain management, along with mobilization and early oral nutrition, is the foundation for optimal recovery after surgery. Unidimensional pain scales (Numerical Verbal Rating Scale - NRS, Visual Analogue Scale - VAS, Categorical Scale - CRS, Facial Pain Scale - FPS) do not adequately reflect a patient's actual analgesic needs. Basing analgesic treatment on the classic algorithm of administering opioids if pain is greater than 4 on the NRS, without considering functional impairment, has been shown to be a cause of overtreatment in surgical wards. The Functional Activity Score (FAS) is the simplest scale, designed for bedside application and geared toward therapeutic decision-making. R: Able to perform any activity; B: Pain prevents some activity; C: Unable to perform any activity. Given the need to standardize functional limitation when measuring postoperative pain, we propose the Pain and Functional Activity Scale (PFAS), which combines the NVA (Non-Visual Analogue Scale) with the Functional Activity Scale. Specifically, pain on movement would be recorded using the NVA in motion (NVAm), along with functional limitation (A, B, or C). The rescue analgesia treatment algorithm adapted to the PFAS would involve treating patients with pain greater than 4 on the NVA whenever it represents a severe limitation of their functional activity (C). In this study, we aim to evaluate whether there are significant differences in the proportion of patients who meet the criteria for needing rescue analgesia according to the NVA compared to the proportion of patients who meet the criteria for needing rescue analgesia established by the PFAS, during the 2-day postoperative period. To this end, an experimental, longitudinal, prospective, randomized, single-blind study for the data analyzer will be carried out, where a group that will receive rescue analgesia if VNS\>4 and another if VNSm\>4 + FAS C will be compared in the first two days of postoperative surgical patients of the surgeries selected in the EOXI of Vigo.

Effects Of Intravenous Oxytocin On Peripheral Sensory Afferents Using Microneurography

The goal of this clinical trial is to learn if oxytocin reduces pain in a small area of skin after pulses of non-burning heat by changing how nerves in the heated area react to pressing a thin, bendable plastic bristle and a thick, non-bending plastic bristle in adult, healthy participants. The man questions it aims to answer are: Does oxytocin increase the number of times a fiber which normally responds only to the thin bristle fires (sends a signal) after the heat pulses. Does oxytocin raise the number of times a fiber which normally responds only to the thick bristle fires (sends a signal) after the heat pulses. Researchers will compare oxytocin to a placebo (a look-alike substance that contains no drug) to see if oxytocin ABC works to change how nerves react to light touch and painful pressing in an area of sensitized skin. Participants will: Receive an intravenous injection of oxytocin or placebo on one occasion On the same day, a needle will be put near nerve fibers to record their firing before and after a few cycles of short heating of the skin.

Quadro-Iliac vs Thoracolumbar Interfascial Plane Block for Analgesia After Single-Level Lumbar Disc Surgery

The investigators aim to compare the postoperative analgesic efficacy of the classical thoracolumbar interfascial plane block and the Quadro-iliac plane block for postoperative analgesia management after lumbar disc surgery.