Clinical Research Directory

Evaluating the Efficacy of Force Modulating Tissue Bridge Device in Preventing Hypertrophic Scars Following Gender-Affirming Mastectomy

The goal of this randomized, prospective, interventional clinical trial is to evaluate the use of Brijjit® in reducing the incidence of hypertrophic scarring in individuals undergoing gender-affirming bilateral double incision mastectomies at a single-institution, single-surgeon site (Esther A. Kim, MD). Patients will serve as a self-control (one side of the chest receives intervention, the other serves as a control). Primary endpoints include scar appearance and quality. Secondary endpoints include patient perception of the scar using the Patient and Observer Scar Assessment Scale (POSAS). Participants will be taught how to apply Brijjit® at home if any units fall off before 6 weeks postop.

Reverse Fly Exercise On Supraspinatus Tendinitis In Patients Receiving Aromatase Inhibitors Therapy After Mastectomy

Reverse Fly Exercise On Supraspinatus Tendinitis In Patients Receiving Aromatase Inhibitors Therapy After Mastectomy

Single vs Multiple Injection Intertransverse Process Block in Breast Cancer Surgery

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of single Intertransverse Process Block (ITP) and multiple Intertransverse Process Block (ITP) in patients undergoing Breast Cancer Surgery. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire.

Long-term Outcomes of Lidocaine Infusions for Post-Operative Pain (LOLIPOP) Trial

The LOLIPOP Trial is a large (n=4,300 patients) pragmatic, international, multicentre, prospective, randomised, double blind, placebo-controlled, parallel assessment, safety and effectiveness superiority study.

Transverse vs. Longitudinal Serratus Anterior Plane Block in Breast Surgery

The aim of this prospective, randomized controlled trial is to compare the analgesic efficacy of transverse versus longitudinal ultrasound probe orientations during Serratus Anterior Plane (SAP) block in patients undergoing breast surgery. The study hypothesizes that the longitudinal approach (probe parallel to the ribs) may provide better craniocaudal spread of the local anesthetic, thereby resulting in lower postoperative Visual Analog Scale (VAS) scores and reduced opioid consumption compared to the standard transverse approach.

Interactive Design of Patient-Specific Molds for Tissue Shaping

The goal of this study is to develop clinical decision-support algorithms for designing participants-specific breast molds for tissue shaping. Autologous breast reconstruction is an important part of breast cancer rehabilitation for many participants. Our goal is to increase the efficiency of autologous breast reconstruction by helping the surgeon design participants-specific molds for shaping tissue into an acceptable breast form.

Affecting Factors for Chronic Pain After Mastectomy

Chronic post-mastectomy pain (CPMP) is a significant issue affecting many women after mastectomy. Factors like age, treatment type, and pre-surgery pain can increase the risk of developing this condition. By evaluating these factors, CPMP can be prevented more successfully and treatment strategies can be developed. This study aims to investigate the factors contributing to CPMP and contribute to the existing literature on this important topic.

Analgesic Efficacy of Combined PECS II and PIP Block Versus Thoracic Paravertebral Block Post-Mastectomy

Postoperative pain management is crucial for patients undergoing mastectomy for breast cancer. Regional analgesia techniques, such as the Thoracic Paravertebral Block (TPVB), are commonly used to reduce pain and opioid consumption; however, TPVB carries potential risks, including pneumothorax. Interfascial plane blocks, specifically the Pectoral Nerve II (PECS II) block combined with the Superficial Parasternal Intercostal Plane (PIP) block, have emerged as alternative techniques to provide comprehensive analgesia to both the lateral and anterior chest wall. The purpose of this randomized controlled trial is to evaluate and compare the analgesic efficacy and quality of postoperative recovery between a combination of ultrasound-guided PECS II and PIP blocks versus the standard Thoracic Paravertebral Block (TPVB) in patients undergoing mastectomy with or without axillary lymph node dissection (ALND). Participants will be randomly assigned to receive either the combined PECS II and PIP block or the TPVB following general anesthesia induction. Pain scores, total opioid consumption, time to first analgesic request, quality of recovery using the QoR-15 questionnaire, and potential block-related complications will be monitored and compared over the 24-hour postoperative period.

Contribution of Auriculotherapy in the Management of Mastectomy With Immediate Reconstruction by Latissimus Dorsi Flap (ATMAGD)

Over the past decade, more and more healthcare professionals are using auriculotherapy as a preventative and effective therapy for pain. This therapy is applied by odontologists, anesthetists, surgeons, etc., to alleviate chronic pain. The effects of auriculotherapy are known in particular in reducing preoperative anxiety, pain in cancer patients and postoperative pain. The aim of this study is to assess the effectiveness of adding auriculotherapy to the standard global anesthetic protocol, compared to this single reference protocol, on the incidence at 3 months post-intervention of Chronic Post-Surgical Pain, in patients operated for a mastectomy with reconstruction immediate by latissimus dorsi flap.

Biological and Clinical Underpinnings of Postoperative Pain - Mastectomy

Persistent pain after mastectomy remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after mastectomy and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims: 1. We will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery. 2. We will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases. 3. We will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery. 4. We will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.

A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.

Hybrıd Educatıon Based on Psychodynamıc Nursıng Theory of Women Undergoıng Mastectomy

Our study aims to investigate the effects of planned hybrid (web-based and face-to-face) group training to be given to women with mastectomies based on Psychodynamic nursing theory, on women's body value, social appearance anxiety and sexual life quality. Power analysis was performed for the study group of the study and intervention and control groups were created by randomization method (intervention group n = 30, control group n = 30). The study will be applied as a pretest-posttest experimental intervention method. In order to make an evaluation before and after the planned hybrid training, the situations that are most affected by women after mastectomy were analyzed in line with the literature and the data were collected from the Sociodemographic Characteristics Form, Body Value Scale-2, Social Appearance Anxiety Scale (SAAS), Sexual Quality of Life Scale-Female (SQOL-W). will be collected using. A standard information brochure containing information about mastectomy will be given to the intervention and control groups after the pre-test. Then, hybrid group training based on Psychodynamic Nursing Theory will be given to the intervention group by the researcher. A Whatsapp group will also be established to enable patients to communicate and ask questions. During the process, 9 web-based and 3 face-to-face group trainings will be held. A posttest will be administered to both groups at the end of the last group training, and a permanence test will be administered 1 month later via Google surveys on the Whatsapp group. SPPS program and Pearson Chi-square test, Independent Samples Test, McNemar, Pearson Chi-square test, ANOVA (Repeated Measures ANOVA) will be used to analyze the data. As a result of the study, in line with the research findings, the effect of hybrid group training based on Psychodynamic Nursing Theory on the body value, social appearance anxiety and sexual life quality of women who have undergone mastectomy will be evaluated.

Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) and Rhomboid Intercostal Block in patients undergoing Breast Cancer Surgery With Axillary Lymph Node Dissection. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire.

Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Prospective, monocentric, open-label study conducted in women requiring mastectomy and eligible for tumescent infiltrative anaesthesia. Blood samples will be collected during 48h after start of infiltration. Total and free lidocaine concentrations measurements will be determined by gas chromatography. Visual analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs and adverse effects will be collected. Population pharmacokinetic parameters will be estimated using NONMEM software and covariates influence on parameters variability will be tested. Primary outcome value: Population pharmacokinetic parameters with possible covariates influence on variability. Patients and period of study: n=30 patients enrolled during 24 months, total study duration: 30 months.

Effect of Patient-Anesthesiologist Gender Concordance and Analgesia Method on Postoperative Pain in Mastectomy Patients

This prospective observational study aims to evaluate the effect of anesthesiologist gender and patient-anesthesiologist gender concordance, as well as the analgesia method, on postoperative pain levels and analgesic requirements in patients undergoing elective mastectomy for breast cancer. The study will also investigate the impact of these factors on intraoperative and postoperative anesthesia-related complications. Findings are expected to contribute to the understanding of gender-based differences in patient outcomes and guide improvements in perioperative care.

The Role of Amnion Membrane Allografts in Nipple Preservation

The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing nipple sparing mastectomy (NSM). dHACM allografts are commercially available tissue membranes with biocompatible extracellular matrix and growth factors that have been shown to improve wound healing in patients with chronic and lower extremity wounds. To date, no study has evaluated the impact of dHACMs on NAC preservation following NSM. Investigators hypothesize that subareolar surgical implantation of dHACM allografts at time of NSM will reduce NAC necrosis and improve viability.

A Bionic Breast Project Using Neuroprosthesis to Reduce Chronic Pain After Mastectomy

This trial seeks to establish whether or not touch sensation can be restored to the breast via neural stimulation. Data will also be obtained to inform future feasibility (including safety), efficacy, and acceptability trials.

Assessment of the Interi Manifold in Implant-Based Breast Reconstruction

Patients with breast cancer that elect to undergo implant-based breast reconstruction (IBBR) often require the placement of a surgical drain. Surgical drains are used to manage dead space and prevent seroma formation or accumulation of fluid within the surgical field postoperatively. The most frequently used drain is a Jackson-Pratt (JP) drain, which is limited by poor surgical site coverage and low capacity, leading to inconsistent suction and prolonged time that a drain is left in place. The Interi Drain system is a novel, multi-branched manifold with a proprietary suction system that provides consistent suction and addresses many of the shortcoming of JP drains. The purpose of this study is to compare the Interi system to standard JP drains across outcomes including number of surgical drain sites, complication rates, time to drain removal, time to initiate tissue expansion, total fluid volume drained, and patient satisfaction.

Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer

The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction. The study will also look at quality of life, satisfaction with care, hospital resource use, and environmental impact. The main questions it aims to answer are: 1. Does the AMADeuS pathway control pain during the first 48 hours after surgery as well as usual hospital care? 2. Is the AMADeuS pathway as safe as usual hospital care during the first 30 days after surgery? 3. Can the AMADeuS pathway improve recovery, reduce hospital stay and hospital visits, and lower the environmental impact of care? Researchers will compare the AMADeuS pathway with usual hospital care. In the AMADeuS pathway, participants will have awake surgery with monitored anesthesia care, same-day discharge when safe, and follow-up that includes telemedicine. In the usual care group, participants will receive the hospital's standard perioperative care, which usually includes admission to the ward and follow-up visits at the hospital. Participants may be women 18 to 75 years old who need nipple-sparing or skin-sparing mastectomy with immediate prepectoral reconstruction for early breast cancer or to lower future breast cancer risk. Participants must be suitable for day surgery and telemedicine follow-up. This includes having home support during the first 24 hours after surgery and living close enough to the hospital for safe discharge. Participants will: * be assigned by chance to the AMADeuS pathway or to usual hospital care have mastectomy with immediate prepectoral reconstruction report their pain during the first 48 hours after surgery * be checked for medical problems during the first 30 days after surgery complete questionnaires about quality of life, symptoms, and satisfaction with care during follow-up * have follow-up visits either through telemedicine and planned local care support or through standard hospital follow-up, depending on the group they are assigned to

Investigation of the Effects of Serratus Posterior Superior Intercostal Plane Block and Serratus Anterior Plane Block on Perioperative Analgesia Management in Patients Scheduled for Mastectomy

This study aims to evaluate and compare the analgesic efficacy of two ultrasound-guided regional anesthesia techniques, the serratus anterior plane (SAP) block and the serratus posterior superior intercostal plane (SPSIP) block, in patients undergoing elective mastectomy surgery. Postoperative pain following mastectomy is a common and significant clinical problem that negatively affects patient comfort, delays mobilization, and may prolong hospital stay. Although systemic analgesics are commonly used, they are associated with adverse effects such as sedation, constipation, and potential dependency. In this randomized clinical study, female patients aged 18-75 years with ASA physical status I-III scheduled for elective mastectomy will be included after obtaining informed consent. Patients will be allocated into two groups to receive either SAP block or SPSIP block under ultrasound guidance prior to surgery. Standardized general anesthesia and perioperative analgesia protocols will be applied to all patients. The primary objective is to compare postoperative pain scores between the two groups using the Numeric Rating Scale (NRS). Secondary outcomes include time to first analgesic requirement, total analgesic consumption, intraoperative opioid use, and hemodynamic parameters. By comparing these two interfascial plane blocks, this study aims to identify a more effective analgesic technique that improves postoperative pain control, enhances patient comfort, and facilitates early mobilization following mastectomy.

A Study on Pain After Breast Reconstruction

The purpose of this study is to find out how common persistent postmastectomy pain (PPMP) is among people who have had a mastectomy and breast reconstruction surgery for their breast cancer. The study will also look at how effective regenerative peripheral nerve interface (RPNI) surgery is for reducing pain from neuropathic PPMP after breast reconstruction.

Selected Exercise Program on Upper Cross Syndrome Post-unilateral Mastectomy

The purpose of the study is to evaluate the therapeutic efficacy of exercise rehabilitation program on upper limb range and forward head posture post unilateral radical mastectomy.

Adding Amantadine or Duloxetine to Pregabalin on Occurrence of Post Mastectomy Pain Syndrome

This study aims to evaluate the additive effect of Amantadine or Duloxetine to Pregabalin on development of post mastectomy pain syndrome

Stellate Ganglion Block for Prevention of Post Mastectomy Depression

Complications after mastectomy include chronic pain and depression.