Clinical Research Directory

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.

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.

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.

Comparison of the Postoperative Analgesic Efficacy of Classical and Modified Erector Spinae Plane Blocks After Lumbar Spinal Surgery

The investigators aim to compare the postoperative analgesic efficacy of the classical erector spinae plane block and the modified erector spinae plane block in the management of postoperative analgesia after lumbar disc surgery.

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.

Sufentanil Versus Ketamine Intranasally in the Management of Severe Acute Trauma-related Pain in Children.

Pain is one of the most common reasons for children to attend emergency departments, particularly following traumatic injuries such as fractures, sprains, or contusions. Despite advances in medical care, severe acute pain in children is still sometimes inadequately treated. One important reason is that intravenous pain medication can be technically difficult, stressful, or delayed in paediatric patients. Intranasal drug administration, which involves spraying medication into the nose, offers a rapid and needle-free way to relieve pain and is increasingly used in paediatric emergency care. Two medications can be administered through this route: ketamine and sufentanil. Intranasal ketamine is already widely used in children for pain management. Sufentanil is a potent opioid analgesic commonly used in adults and in anaesthesia but has been much less studied in children when administered intranasally. The aim of this study is to compare the effectiveness and safety of intranasal sufentanil and intranasal ketamine in children aged 6 to 17 years who present to the emergency department with severe traumatic limb pain. Both medications will be given in addition to standard care, including the routine use of an oxygen-nitrous oxide gas mixture (MEOPA), which is commonly used to reduce pain and anxiety in children. Children who take part in the study will be randomly assigned to receive either intranasal sufentanil or intranasal ketamine. Pain levels will be assessed at regular time points after medication administration using age-appropriate pain scales. Sedation level and possible side effects will also be closely monitored for a short period following treatment. The hypothesis of this study is that intranasal sufentanil will provide greater pain relief than intranasal ketamine 30 minutes after administration, without increasing the risk of adverse effects, when both are used alongside standard emergency care. The results of this study are expected to improve knowledge about fast, effective, and non-invasive pain relief strategies for children in emergency settings and may help optimise future pain management protocols in paediatric emergency care.

REctus Sheath Trial

Regional anesthesia techniques (or nerve blocks) are used to provide sensory blockade over the abdominal wall. The most established technique is thoracic epidural. This provides bilateral spread but is also associated with neuraxial complications, which has led to a decrease in clinical usage. The rectus sheath block (RSB) is an established regional anesthesia technique used to provide somatic analgesia to the midline anterior abdominal wall by depositing local anesthetic in the posterior rectus sheath, thereby targeting the terminal anterior branches of the lower thoracic intercostal nerves. The conventional approach involves placing the ultrasound (US) probe transversely across the rectus abdominis muscle and advancing the needle in-plane either lateral-to-medial or medial-to-lateral. While this technique achieves spread within the sheath, the cephalocaudal distribution of local anesthetic may be suboptimal, potentially limiting the extent of dermatomal coverage. A longitudinal probe orientation, with needle insertion from cephalad to caudad, may theoretically facilitate a more extensive cranio-caudal spread by aligning the injection axis with the anatomical fascial plane of the posterior rectus sheath. However, the relative efficacy of these two approaches has not been investigated in a controlled, comparative setting. Thus, this randomized, single-blinded trial aims to evaluate the dermatomal sensory distribution and ultrasound-assessed local anesthetic spread achieved by the transverse versus longitudinal in-plane approaches to ultrasound-guided RSB in healthy adult volunteers. To compare the dermatomal sensory block distribution, investigators will use dermatomal mapping with pinprick, and cold.

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.

Characterization of Acute Pain

This study aims to better understand how acute pain and responses to pain treatment can be measured in children and adolescents using a non-invasive device. Pain is usually assessed using self-reported or observational scales, which can be difficult to interpret, especially in pediatric patients. This study will evaluate whether a novel device, the AlgometRx Nociometer, can provide an objective measure of nociceptive pain. Participants ages 6 to 21 years who are undergoing elective surgery or bone marrow transplantation will be enrolled at Children's National Hospital. The device measures changes in pupil size in response to gentle electrical stimulation, which reflects activity in pain-related nerve pathways. Measurements will be taken before and after procedures and during routine hospital care, alongside standard pain assessments. This is an observational study. Participation will not change or guide any medical treatment, and all pain management will follow standard clinical care. The information collected may help improve future pain assessment and treatment for pediatric patients.

Ultrasound-Guided Regional Blocks for Postoperative Analgesia After Laparoscopic Cholecystectomy

Ultrasound (US)-guided recto-intercostal fascial plane block (RIFPB) is a recently described abdominal wall block performed by injecting local anesthetic between the rectus abdominis muscle and the costal cartilage of the 7th rib. Due to the cranial attachment of the rectus muscle, this technique provides effective analgesia to the sternal, epigastric, and upper-mid abdominal regions, corresponding to the T6-T10/11 dermatomal levels. RIFPB may be used as an adjunct technique for thoracic procedures or as a standalone block for abdominal surgery. Ultrasound-guided transversus abdominis plane block (TAPB) is performed by injecting local anesthetic into the fascial plane between the internal oblique and transversus abdominis muscles. TAPB provides sensory blockade of the anterolateral abdominal wall at the T6-L1 dermatomal levels and is widely used for postoperative analgesia following abdominal surgeries, including laparoscopic cholecystectomy. This study aims to compare the effectiveness of US-guided RIFPB and TAPB on postoperative pain control after laparoscopic cholecystectomy.

Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section

The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.

Virtual Reality Devices as an Adjunct to Usual Care for Patients With Sickle Cell Disease Experiencing Vaso-Occlusive Crises

This study aims to evaluate the use of virtual reality as an adjunct to standard care for patients with sickle cell disease experiencing vaso-occlusive crises.

Effectiveness of Retrolaminar Block in Lumbar Spine Fusion With Multimodal Analgesia

This randomized, blinded, controlled clinical trial aims to evaluate the effectiveness of ultrasound-guided retrolaminar block in reducing postoperative opioid consumption in patients undergoing lumbar spine fusion surgery under multimodal analgesia. The participants will: * Be randomly assigned in a 1:1 ratio to receive either a retrolaminar block with 0.25% bupivacaine plus epinephrine or a sham block (normal saline) prior to surgical incision. * Receive standardized multimodal analgesia. * Have follow-up by the Acute Pain Unit during the first 3 days, to assess opioid consumption (morphine) in 24 hours, pain intensity measured by Numeric Rating Scale, quality of recovery assessed by the QoR-15 questionnaire, intraoperative blood loss, and postoperative complications.