Clinical Research Directory

Biopsychosocial Risk Influences on the Development and Generation of Early-Onset Chronic Pain

The purpose of the study is to discover the underlying subtypes of chronic musculoskeletal pain (muscle and joint pain) in youth. Specifically, the researchers are looking for different profiles of brain and immune system signals that affect how the body feels pain, and how these pain profiles are shaped by a person's medical history, psychology, and social environment. The goal is to develop more precise treatments for chronic pain in young people. Primary Aim: The investigators want to identify subtypes of childhood-onset chronic pain (pain lasting more than 3 months) that affects the musculoskeletal system. To do this, the study will enroll teens and young adults (ages 14-26 years) who were diagnosed with chronic pain in childhood (before the age of 18) or have a pediatric rheumatic disease or major surgery that places them at risk for developing chronic pain. The researchers will look at participants' childhood medical histories and treatments, their current pain and other symptoms, sensory tests of pain and immune system markers found in their blood. The investigators will use this information to find different clinical and neuroimmune profiles of chronic pain. They will also be able to identify the profiles of those who are at risk for chronic pain (because of a rheumatic disease or past surgery) but never develop long term pain. Secondary Aim: The study will look at how medical history, treatments, and different lifestyle factors (like sleep and physical activity), and psychosocial factors (mood, coping, social support) influence the pain experience in subgroups of chronic pain identified in the primary aim. By understanding specific behavioral and psychosocial risk and protective factors-the researchers hope to better understand why some young people develop long-lasting pain and others do not and also how better treatments can be developed for those who do have chronic pain.

Serratus Anterior Plane Block and Transthoracic Plane Block in Pectus Surgery

The most important problem in the postoperative period in patients scheduled for pectus deformity correction surgery is pain. Due to the catastrophic neurological complications of thoracic epidural analgesia, the tendency towards plane blocks has been increasing in recent years. Serratus Plane Block (SAP Block), performed under ultrasound guidance, is used to treat pain in thoracic surgery. However, whether it has an effect on sternum pain is still controversial and there are not enough studies. Transversus thoracic plane block (TTP Block) provides effective analgesia in sternotomies. For this reason, we aimed to show that the TTP block added to the SAP block will provide more effective analgesia in order to provide adequate analgesia for the pressure and pain sensation of the bars placed on the sternum in pectus surgery.

ES Catheter vs Cryoablation After Pectus Surgery

Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups: * Time to achieve short-term physical therapy goals and long-term functional outcomes * Compare immediate and long-term postoperative opioid use * Compare numbness on chest of postoperative day 1 and the return of sensation to baseline * Compare the incidence of neuropathic pain and other complications Participants will receive surveys for up to 12 months postoperatively.

Postoperative and Chronic Pain Genetic Spine and Pectus Surgery Study

This will be an open label, prospective study to determine the association between specific genotypes, epigenetics and behavioral factors, with the phenotypes, defined by pain perception, postoperative pain, analgesic and side effect responses to perioperative opioids, chronic postoperative pain and gene expression in adolescents following major spine surgery.

Chest Wall Deformities Beyond the Chest Wall

Pectus excavatum (PE) and pectus carinatum (PC) are chest wall deformities that may influence respiratory function, physical capacity, posture, and quality of life. This observational, cross-sectional study aims to provide a comprehensive and multidimensional evaluation of children with PE and PC and compare their findings with healthy controls. By examining multiple aspects of respiratory and physical function, postural characteristics, and quality of life, the study seeks to provide a broader understanding of the overall impact of these deformities.

Phrenic Infiltration as Cryoanalgesia Adjuvant for Early Postoperative Pain Following the Nuss Procedure

The goal of this observational ambispective study is to compare the effectiveness of two pain management strategies in pediatric patients undergoing the Nuss procedure for pectus excavatum. The main questions it aims to answer are: Does the addition of phrenic Infiltration as Cryo Adjuvant (PhICA) to earlier percutaneous intercostal cryoanalgesia (EPIC) reduce postoperative pain scores compared to EPIC alone? Does the combined EPIC + PhICA technique reduce the need for rescue tramadol compared to EPIC alone? Do the two approaches differ in: length of hospital stay, time to transition to oral therapy, and time to mobilization? Are there any side effects Researchers will compare patients who received EPIC alone to patients who received EPIC + PhICA to see if the combined technique provides superior pain control. Participants: Received either EPIC alone or EPIC combined with PhICA as part of their surgical anesthesia plan Had pain levels assessed using the Numeric Rating Scale (NRS) at regular postoperative intervals Were monitored for rescue tramadol requirements, medicaments taken, length of hospital stay, and mobilization timing Were monitored for any technique-related complication

Pectus Excavatum Camouflage (IT)

The clinical study evaluates the use of a custom-made medical-grade polycaprolactone-PCL Pectus scaffold implantation with Autologous Fat Grafting for pectus excavatum camouflage (IT). The study aims to demonstrate the safety and clinical performance of the insertion of an absorbable "medical-grade polycaprolactone-PCL Pectus Scaffold" in the thorax region with Autologous Fat Grafting in the correction of congenital Pectus Excavatum unsuitable for conventional treatment with stable cardio-respiratory function. The PCL Pectus Scaffold-based design has the potential to induce sustained regeneration to fill large volume pectus excavatum defects, with the added benefit of being light weight and absorbable, thus not affecting the patients function capacity and reducing the risk of implant-related complications.

SPSIPB Versus SAPB for Postoperative Analgesia After Minimally Invasive Repair of Pectus Excavatum

This prospective observational cohort study will compare postoperative analgesic outcomes in patients undergoing minimally invasive repair of pectus excavatum. Participants will be grouped according to the regional analgesia technique applied as part of routine clinical care: serratus posterior superior intercostal plane block or serratus anterior plane block. The primary outcome will be total opioid consumption during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, rescue analgesic requirement, opioid-related adverse effects, patient satisfaction, mobilization time, and length of hospital stay.

Pectus Excavatum Camouflage

The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes. The implanted scaffold acts as absorbable frame to support the growth of cells. The substance used for the scaffold is absorbable, it's similar to the substance used for sutures and stitches, and it's already Therapeutic Goods Administration (TGA) approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.

Does Acupressure Decrease Post-operative Nausea and Vomiting (PONV) After the Pectus Excavatum Correction (NUSS) Procedure?

Post-operative nausea and vomiting (PONV) is not only unpleasant for patients but also can delay hospital discharge and increase cost of stay. In some cases, when severe vomiting occurs, pain scores seem to be increased. The overall incidence of PONV is 30% and increases to 79% in patients at high risk for this post-operative outcome. The NUSS procedure is considered to be a procedure with a high risk for the outcome of nausea and vomiting.

Identification of Best Postoperative Analgesia Method Following a Minimally Invasive Repair of Pectus Excavatum

Pectus excavatum is the most common chest wall deformity in children, accounting for 90% of all congenital chest wall deformities. It occurs in one to eight per 1000 live births. The severity of the pectus deformity may become more noticeable during pubertal growth spurs and repair is therefore usually performed in the teenage years. A common operative procedure to repair a pectus deformity is the minimally invasive repair of pectus excavatum (MIRPE). The MIRPE involves the substernal placement of a contoured metal bar secured to the lateral aspect of the ribs. This metal bar allows for correction of the concave deformity by applying constant outward pressure to the underside of the sternum. Although the cosmetic results are excellent, patients do report significant pain from the constant pressure exerted on the chest wall from the metal bar. Pain management approaches tend to differ on both the provider and institutional level. There is a lack of evidence regarding which postoperative analgesia method is best. To address this research gap, this proposal aims to conduct a randomized controlled trail using the three most commonly used methods; 1) patient controlled analgesia (PCA); 2) erector spinae blocks (ESB) with continuous infusion pumps; and 3) video-assisted intercostal nerve cryoablation (INC).

Field-test and Psychometric Validation of the Pectus Excavatum Evaluation Questionnaire in the Dutch Pectus Excavatum Population

A questionnaire that can measure disease severity from the patients perspective in patients with pectus excavatum already exists in English (Pectus Excavatum Evaluation Questionnaire; PEEQ). This questionnaire was recently translated into Dutch. Before this Dutch version can be used, it needs to be tested by a number of patients. Data will be collected at three moments: 1. Preoperatively: The PEEQ will be completed on paper during the outpatient clinic visit. 2. Postoperatively: The PEEQ will be completed electronically 2 months post-surgery. 3. Test-retest reliability: The PEEQ will be administered electronically at least two weeks after a previous assessment.

Intraoperative Cryoanalgesia Versus Thoracic Epidural Block in MIRPE (Minimally Invasive Repair of Pectus Excavatum)

The main objective of this study is to compare epidural blockade with cryoanalgesia of the intercostal nerves as an analgesic method in the postoperative period of minimally invasive repair of pectus excavatum (MIRPE).

Comparative Analysis Of Modified Vs. Classical Nuss Technique In The Surgical Correction Of Pectus Excavatum "

Although the NUSS technique has become the standard minimally invasive procedure for correcting this deformity, there is a lack of comparative data between the classic and modified NUSS techniques. This research aims to fill this gap by comparing these two methods in terms of various outcomes, such as operative time, postoperative pain control, length of stay in the intensive care unit, and overall cosmetic results. This study addresses the need to optimize surgical techniques to improve patient outcomes. By evaluating these two approaches, the research seeks to provide insights that could lead to better management strategies for patients with pectus excavatum, potentially influencing future clinical practices.

Percutaneous Intercostal Cryoneuromodulation Onset Timing.

Percutaneous Intercostal Cryoneurolysis is a promising technique that addresses acute postoperative pain after Nuss procedure for pectus excavatum. However its onset timing has not yet been determined. A physical examination would assess the variation of chest skin sensitivity to soft touch, cold (water at 4°C), and heat (water at 40°C) through days following the cryoneurolysis procedure.

Effectiveness of One-Minute Versus Two-Minute Cryoanalgesia in Nuss Surgery

Intercostal nerve cryoanalgesia has become a popular method for managing postoperative pain after Nuss procedure, showing greater effectiveness compared to epidural anesthesia and patient-controlled analgesia. However, the optimal duration of cryoanalgesia remains unknown. Most protocols use a two-minute cryoablation, although histological studies show similar changes with both one-minute and two-minute applications. This is a pilot, single-center, randomized, double-blind study comparing the effectiveness of one-minute versus two-minute cryoanalgesia in treating pain in patients undergoing correction of pectus excavatum using the Nuss procedure. The aim of the project is to evaluate the validity of the research procedure and determine the sample size for the main study. Preliminary data on postoperative pain intensity, opioid consumption, duration of surgery, length of hospital stay, and complications will be analyzed.

Investigation of the Effectiveness of Telerehabilitation Training in Pectus Excavatum Deformity

The aim of this study is to investigate the effectiveness of telerehabilitation-based exercise training in addition to Vacuum Bell therapy on physical fitness, respiratory functions, posture and psychosocial factors in boys aged between 10-14 years diagnosed with pectus excavatum.

Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

The physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. These functional benefits outweigh the aesthetic benefits associated with anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated. Assessment of Effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods. Anatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by MRI, and 2) of the heart by echocardiography. Noninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (VO2max). Subjective assessment of functional gain between the initial and final balance sheet, based on EVA scales, valued by patients, parents and doctors.