Clinical Research Directory

Suzetrigine (Journavx) as Multimodal Therapy for Pain Management in Adults Undergoing Surgery for Hip Fracture

The goal of this clinical trial is to learn whether suzetrigine (Journavx®), when added to standard multimodal pain management, can reduce opioid use while providing adequate pain control in adults undergoing surgery for an acute hip fracture. The study will enroll adults aged 18 years or older with femoral neck, intertrochanteric, pertrochanteric, or subtrochanteric hip fractures requiring operative treatment at Beth Israel Deaconess Medical Center. Although enrollment is open to adults aged 18 years and older, the study population is expected to consist predominantly of older adults. The main questions the study aims to answer are: * Does treatment with suzetrigine as part of multimodal pain therapy reduce postoperative opioid consumption, measured as morphine milligram equivalents (MME), during the index hospitalization through 72 hours after surgery or hospital discharge, whichever occurs first? * Does suzetrigine provide effective postoperative pain control and have an acceptable safety and tolerability profile in adults undergoing hip fracture surgery? Researchers will compare participants receiving suzetrigine plus standard multimodal analgesia with matched historical BIDMC patients who underwent similar hip fracture surgery between 2020 and 2025 and received standard multimodal analgesia without suzetrigine. Historical controls will be matched on factors including age, sex, fracture type, surgery type, surgeon, ASA class, opioid-naïve status, regional anesthesia, and relevant comorbidities. Participants in the prospective study will: * Receive a 100-mg oral loading dose of suzetrigine before surgery, followed by 50 mg orally every 12 hours for up to 14 days or until pain resolves, whichever occurs first. * Receive standard multimodal pain management, which may include acetaminophen, nonsteroidal anti-inflammatory medications when appropriate, regional anesthesia, and rescue opioid medication as clinically needed. * Complete pain assessments during hospitalization and at follow-up time points, with opioid use recorded and converted to MME. * Complete follow-up assessments at approximately Days 7, 14, and 28 after surgery, including pain, medication use, adverse events, treatment adherence, and patient-reported outcomes. * Record study medication use, missed doses, rescue opioid use, and adverse events after hospital discharge when applicable.

Pericapsular Nerve Group Block Versus Intrathecal Morphine for Pain After Hip Surgery

Pain after hip replacement surgery is often severe and is commonly treated with opioids, which may cause nausea, vomiting, sedation, difficulty passing urine and slow breathing. This study will compare two ways of controlling pain in adults having hip surgery under spinal anesthesia. One group will receive morphine added to the spinal injection. The other group will receive an ultrasound-guided pericapsular nerve group (PENG) block, in which local anesthetic is injected near the nerves that carry pain signals from the hip joint. Participants will be assigned to one of the two groups by chance. Sixty-four adults aged 18 to 65 years will take part, with 32 in each group. Pain scores at rest and during movement, the total amount of morphine used through a patient-controlled pump, the time until the first request for extra pain medicine, the amount of additional paracetamol used, side effects such as nausea and vomiting, and complications related to the block will be compared between the groups during the first 48 hours after surgery.

Improving Shared DECISion-making in oldEr Hip Fracture Patients Living With Frailty

Title Improving shared decision-making in older hip fracture patients living with frailty Aim To use routinely information normally collected by the NHS, and interviews with patients, families, and healthcare professionals, to produce an aid to help patients make decisions about hip fracture treatment that reflects what is important to them. Background Breaking a hip after a fall is common in older adults. The risk of dying is high after a hip fracture, especially if the person does not have surgery. Most UK patients have surgery even if they are very frail. Patients who are at a very high risk of dying still have surgery to help control the pain. However, this is not the same in all countries and recent studies show pain can be well controlled with medications and nerve-numbing drugs. Whilst the risk of dying is still much higher without surgery, to some frail older adults there are more important things to them than living longer like being able to walk and look after themselves. Some people may choose end-of-care instead of an operation if surgery means they won't be able to do these things afterwards. To help frail older people make the decision that is best for them, they need information about all treatment options and what their life is likely to be like after. This information needs to be easy to understand. Why the research is important This research will give frail older people with hip fractures the information they need to make decisions that focus on what is most important to them. We will make a guide to present the information in a way that is easy to understand and will help patients make decisions alongside healthcare professionals. Design We will complete 4 Work Packages (WPs): WP1: What do we already know about the link between frailty and the ability for older people to move and look after themselves after hip fracture? • We will review all current studies that look at what frail older peoples' lives are like after having a hip fracture and combine all the information in these studies. This will stop us from repeating work already done and show us any gaps in knowledge. WP2: Can we use how frail someone is and other information to predict their ability to move and look after themselves after a hip fracture? • We will use data the NHS collects to explore links between frailty, health and social issues, and a person's ability to move, walk, and care for themselves after hip fracture. I will see if these factors predict which people will do better after a hip fracture. WP3: What factors affect treatment decisions in frail adults with a hip fracture? • We will interview older hip fracture patient with frailty, families, and healthcare staff to explore how decisions are made about hip fractures and how we can improve this. WP4: Creating and testing an aid to help older patients with frailty make decisions about hip fracture treatment • We will work with patients to design a decision aid to improve shared decision-making in hip fracture care. We will test out the aid on orthopaedic wards in Southampton and improve it based on feedback.

Mobility and Activity of Daily Living Outcomes After a Hip Fracture.

Hip fractures in especially older adults cause severe clinical and functional impacts. Despite improved surgical care, one year mortality remains 14-30%, and fewer than half of the survivors regain their pre-fracture functional status. After a hip fracture, patients are primarily concerned with what they will be able to do in daily life. Wihout accurate predictions of mobility and Activities of Daily Life (ADL) independence, it is difficult to set realistic expectations and make appropriate decisions regarding treatment and rehabilitation. While there have been advancements in developing predictive models for mortality following hip fractures, there is a notable gap in models focused on predicting functional recovery. This study aims to develop and validate a machine learning-based model that can predict mobility and ADL independence three months after obtaining a hip fracture.

Population Pharmacokinetics and Pharmacodynamics of Ciprofol

The goal of this observational study is to learn how the anesthetic drug ciprofol works in older adults who are having limb surgery under general anesthesia at Shanghai Geriatric Medical Center. The study will help researchers build a population model to better understand how the drug moves through the body (PK) and how it affects patients (PD). This model may help doctors use a Target-Controlled Infusion (TCI) system to adjust the drug dose more precisely. The main question it aims to answer is: Does ciprofol work safely and effectively in older adults during orthopedic surgery? Participants already receiving ciprofol as part of their regular anesthesia care will: 1. Provide blood samples at different time points during and after surgery. 2. Have their vital signs and anesthesia-related data recorded before, during, and after surgery. 3. Be monitored for side effects and recovery indicators such as the Aldrete score and signs of postoperative delirium. Researchers will use this information to: 1. Build and test a population PK/PD model for ciprofol. 2. Simulate recommended TCI dosing plans. 3. Explore how individual responses to ciprofol relate to recovery and safety outcomes. This study may help improve anesthesia care for elder adults by making drug dosing safer and more effective.

Pre- and Postoperative Chest Therapy With Positive Expiratory Pressure (PEP) to Prevent Hospital-acquired Pneumonia

The goal of this clinical trial is to investigate whether pre- and postoperative treatment with systematic PEP therapy can prevent hospital-acquired pneumonia in patients with hip frac-ture. It will also learn about the barriers regarding PEP therapy in this group of patients. * Does pre- and postoperative treatment with systematic PEP therapy prevent hospital-acquired pneumonia in patients with hip fracture? * Which barriers do participants have regarding PEP therapy in this group of patients? Researchers will compare systematic PEP therapy to no intervention besides standard treat-ment to see if systematic therapy with PEP can prevent hospital-acquired pneumonia. Participants will: * Receive systematic PEP therapy during hospitalization or no intervention besides standard treatment * Register the PEP therapy four times daily on a paper checklist. Failure to perform the treatment and the reason must also be documented on the checklist.

Frailty Intervention in Postoperative Hip Fracture Inpatients

Hip fracture is a big health concern in older adults, and can lead to increased risk of death, reduced level of independence \& mobility, reduced quality of life, and higher likelihood of admission to nursing homes. Frailty is a medical condition associated with ageing that results in a reduced ability to do daily tasks. A frail older adult is also less able to recover well from conditions that may affect their wellbeing (for example, infections, falls resulting in injuries or hospital admissions). Frailty is common in older adults with hip fractures. There has been increasing research showing that frailty can be slowed down and improved by a combination of nutritional supplementation and exercise. However, most of the research in this area has been in frail older adults living at home or in nursing homes. The exercise or nutritional programs in these studies tend to be carried out over weeks or months. There are very few studies looking at older adults in hospital and how exercise and nutrition help with frailty over shorter periods of time, even more so in patients who have sustained an injury. There is, however, very little research in hospital based frailty programs in older patients who have suffered major trauma. It is well known that standing up and starting to walk soon after a hip fracture improves time to recovery, reduces hospital length of stay and death. Hence, physiotherapy on the first day after hip fracture surgery is now recommended. However, there needs to be more research to aid in developing physiotherapy and exercise programs that are safe and doable in the care of hip fracture patients despite limited resources in our healthcare system. Similarly, although malnutrition is common in frail older adults with hip fractures, the benefits of nutritional supplementation in these patients is not fully understood. It is known that having a hip fracture puts a person at risk of muscle breakdown and increasing protein intake is recommended to help reduce this risk. Research on exercise and nutrition based frailty programs specific to hip fracture patients is strongly needed, specifically the development of that are doable and safe in the hospital setting that can help improve outcomes in hip fracture patients after surgery. The investigators believe that a multicomponent exercise and nutrition based frailty program will be safe, doable and acceptable in frail older adults after hip fracture surgery.

Rehabilitation in the Home After Hip Fracture

Hip fractures are common, especially in older adults, and they can have a big impact on health and quality of life. In Australia, hip fractures are a significant healthcare challenge. After surgery, patients often need rehabilitation to regain mobility, but this usually involves long hospital stays. The RITH4Hips trial will determine if a program where patients receive rehabilitation at home (instead of in the hospital) is similar to conventional inpatient rehabilitation. Objectives: The main goal of this study is to find out if rehabilitation at home after surgery for a hip fracture works as well as rehabilitation in the hospital. The investigators also want to see if the home rehabilitation program can reduce the time spent in a hospital bed and improve other aspects like quality of life, mobility, and pain management. Methods: This study will involve older adults who have had surgery due to a low-trauma hip fracture. Participants will be randomly assigned to either the usual care inpatient rehabilitation or the Rehabilitation in the Home (RITH) program. The investigators will measure outcomes such as how well patients can move, how much pain they experience, how their quality of life improves, and how much time they spend in the hospital. Expected Outcomes: The investigators expect that the home rehabilitation program will be just similar to inpatient rehabilitation in helping patients recover mobility. The investigators also hope to find that it will reduce the time patients spend in a hospital bed, improve their quality of life, reduce fear of falling, and lessen the burden on carers. Additionally, the investigators aim to show that the home program is more cost-effective than hospital-based rehabilitation.

Effect of Transcranial Direct Current Stimulation on Postoperative Delirium in Elderly Patients

To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing the incidence of postoperative delirium (POD) in elderly patients undergoing hip fracture surgery. This single-center, double-blind, randomized controlled trial will enroll participants aged 65 years and older, scheduled for elective hip surgery under spinal anesthesia. Participants will be randomly assigned to either the active-tDCS group or the sham-tDCS group. The active-tDCS group will receive two sessions: one pre-surgery and one post-surgery, with electrodes positioned over the left dorsolateral prefrontal cortex and the right supraorbital area. Each session includes 15-second ramp-up phase at the start, 20 minutes simulation with 2 mA current and 15-second ramp-down phase at the end. The sham-tDCS group will receive two sham procedures with no actual current delivered. Functional brain activity will be monitored before and after each session or sham procedure to assess changes in cortical activation and connectivity using functional near-infrared spectroscopy (fNIRS). The primary outcome measure will be the incidence of POD, assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). Secondary outcomes include the severity of delirium, postoperative pain, anxiety, depression, cognitive function, and sleep quality.

Time on Feet After Hip Fracture Event

With simple technology investigators can map how long it takes for a patient with a hip fracture to be helped and encouraged to stand and walk in the days following the injury. A small sensor on the thigh can measure advanced data regarding movement patterns. The limited research results available show that patients spend too much time lying down or sitting, which can lead to poorer recovery, complications, and an increased risk of death. The project maps the current situation in orthopedic emergency care as well as in orthopedic geriatric care, which is provided in a modern building with single rooms and private bathrooms. In addition to better understanding the significance of different care models, the project aims to present baseline data that future intervention studies can use as control material. The project will also connect the activity level of the patients during the hospital stay with ongoing rehabilitation studies in community follow-up care.