Clinical Research Directory

Superficial vs Deep Serratus Anterior Plane Block for Analgesia After Mammoplasty

The serratus anterior plane block (SAPB) is an ultrasound-guided fascial plane block used for perioperative analgesia in thoracic and breast surgeries. This technique involves the injection of local anesthetic into either the superficial or deep interfascial plane around the serratus anterior muscle at the mid-axillary line, targeting the lateral cutaneous branches of the intercostal nerves and providing analgesia to the anterolateral thoracic wall. The present prospective, comparative, single-blind clinical study aims to compare the postoperative analgesic efficacy of superficial and deep SAPB techniques in patients undergoing mammoplasty surgery. The primary objective is to evaluate total opioid consumption within the first 24 hours postoperatively,while secondary outcomes include postoperative pain scores,additional analgesic requirements, postoperative nausea and vomiting, patient satisfaction, time to first mobilization, and vital signs within the first 24 hours postoperatively. The results of this study may help determine the more effective SAPB technique for improving postoperative pain control and reducing opioid use in patients undergoing mammoplasty.

B4P Trial - BLOOM43 for Preconditioning

The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer. This study aims to understand a participant's experience of the device, including its usability and acceptability. Participants will use the device to precondition their breast the evening before undergoing surgery (mastectomy with immediate autologous and/or implant-based reconstruction).

Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Perioperative Negative Emotions in Breast Cancer Surgery Patients

A multicenter, randomized, double-blind, sham-controlled trial to investigate the effects of a single session of intraoperative transcutaneous auricular vagus nerve stimulation (taVNS) on perioperative negative emotions (anxiety and depression), pain, nausea, sleep, and recovery in patients undergoing elective breast cancer surgery.

Breathing Interventions for Postoperative Breast Surgery Patients

This randomized controlled trial aims to evaluate the effects of pranayama and pursed-lip breathing exercises on postoperative pain, anxiety, and vital signs in patients undergoing breast surgery. Postoperative pain and anxiety are common problems that can negatively affect recovery, physiological stability, and overall well-being. Non-pharmacological interventions such as breathing exercises may help reduce these adverse outcomes and support recovery. Participants will be randomly assigned to one of three groups: a pranayama breathing exercise group, a pursed-lip breathing exercise group, or a control group receiving routine postoperative care. Breathing exercises will be performed three times daily for five minutes. Outcomes including pain, anxiety, and vital signs will be measured at baseline (pretest), postoperative day 1, and postoperative day 2. The findings of this study are expected to provide evidence on the effectiveness of breathing exercises as supportive nursing interventions in the postoperative care of breast surgery patients.

CO2Lift and T-Junction Breakdown Rates Evaluation After Breast Reduction Surgery Pilot Trial

The goal of this pilot study is to determine the feasibility of a larger randomized controlled trial evaluating CO₂Lift® Pro Carboxy Gel to reduce wound breakdown after bilateral breast reduction in adult female patients undergoing elective bilateral breast reduction surgery. The main question it aims to answer is: Is it feasible to recruit, retain, and treat patients while maintaining blinding and monitoring safety? Exploratory questions include: (1) Does CO₂Lift® reduce the incidence of wound breakdown compared with placebo? (2) Is CO₂Lift® safe and well-tolerated in the postoperative period? Researchers will compare CO₂Lift® applied to one breast to placebo (Vaseline®) applied to the contralateral breast to see if CO₂Lift® can improve wound healing and tissue oxygenation. Participants will: * Undergo bilateral breast reduction surgery. * Receive CO₂Lift® on one breast and placebo on the other, starting immediately after surgery and daily in clinic from postoperative days 1 to 6. * Attend weekly postoperative follow-up visits for 12 weeks for wound assessment and monitoring of adverse events. * Have standardized photographs and near-infrared spectroscopy measurements taken to evaluate tissue oxygenation and healing.

A Retrospective Analysis of Robot-Assisted Versus Endoscopic Breast-Conserving Surgery for Breast Cancer

Robotic surgical systems provide notable advantages including enhanced dexterity, a magnified three-dimensional high-definition view, and high-resolution imaging, thereby improving operative stability and precision. These features make robotic systems particularly suitable for procedures performed within confined operative spaces. As the breast is a solid organ without a natural cavity, robotic systems demonstrate strong adaptability for breast surgery. Robot-assisted breast-conserving surgery (RABCS) is one of the currently utilized robotic techniques in clinical breast cancer surgery. However, as robotic breast surgery remains in its early stage of development, evidence regarding the clinical outcomes of RABCS remains limited in the literature. Therefore, this study compares the surgical outcomes of endoscopic breast-conserving surgery and robot-assisted breast-conserving surgery in breast cancer patients, aiming to assess and elucidate the clinical value of RABCS.

The Impact of Breast Surgery on Patients' Quality of Life

The investigators aim to document the surgery-specific and overall Quality of life parameters of patients undergoing all types of breast surgery at the University Hospital of Basel

Omission of Axillary Lymph Node Dissection in Case of Tumor Spread to Lymph Nodes in the Armpit in Breast Cancer

SENOMAC-ULTRA enrols patients who are planned for upfront surgery for a breast cancer that has spread to lymph nodes in the armpit, and that have been detected already prior to surgery by imaging, e.g. ultrasonography. In this situation, a full axillary lymph node dissection, removing more than 10 lymph nodes from the arm pit, is unnecessarily extensive in about half of the patients. More extensive surgery leads to a risk for arm lymphedema and functional problems with the arm and shoulder region, which should be avoided if not beneficial for diagnosis or prognosis. This trial seeks to ascertain that less extensive surgery, performed by only removing the first lymph node/s in the armpit (the sentinel lymph node/s) and the known metastatic lymph nodes (targeted axillary dissection, TAD), offers non-inferior survival outcomes to a full axillary lymph node dissection.

Development and Usability Evaluation of an Arm Circumference Measurement Tool For Patients Undergoing Breast Surgery

The aim of this study is to develop an arm circumference measurement device that can be used by both patients and nurses in the follow-up of upper extremity lymphedema, which may occur as a result of breast cancer surgery, and to evaluate its usability. This study also seeks to determine whether the developed device can offer a more accurate, faster, and more practical alternative compared to traditional tape measurements. The main questions it aims to answer are: Is there a significant difference in intra-observer reliability between the measurements taken by nurses and patients using the arm circumference measurement device and those taken using a traditional tape measure? Is there a significant difference in inter-observer reliability between the measurements taken by nurses and patients using the arm circumference measurement device and those taken using a traditional tape measure? Is there a significant difference in the measurement results obtained by nurses and patients when using the arm circumference measurement device compared to a traditional tape measure? Do nurses and patients experience a difference in the duration of arm circumference measurements when using the measurement device versus a traditional tape measure? Is there a difference in the satisfaction levels of nurses and patients regarding arm circumference measurements performed with the measurement device versus a traditional tape measure? This study will be conducted in two phases: the first phase involves the development of the arm circumference measurement tool, and the second phase involves the evaluation of its usability through a double-blind, two-group, crossover randomized controlled trial.

Serratus Posterior Superior Intercostal Plane Block, Versus Erector Spinae Facial Plane Blocks

Mastectomy is currently the most effective treatment for breast cancers in women. postoperative pain management carries a high degree of difficulty, as the breast has complex innervation involving the intercostal (T1-T7), superficial cervical plexus (supraclavicular nerves) and brachial plexus .While severe acute pain is observed in approximately 40% of post-mastectomy patients, moderate-to-severe pain is observed in almost one-third of them .

Ultrasound-guided Pectoral Nerve Blocks, Thoracic Erector Spinae Plane Block and Serratus Anterior Plane Block for Breast Surgery

The study will compare ultrasound-guided Pectoral nerve block, Erector Spinae Plane block, and Serratus anterior plane block for pain management following elective breast surgeries

Safety & Performance of CANOpus PINtuition Surgical Marker Navigation

The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are: 1. Can the Canopus Marker be safely and effectively used to mark tissue for surgical removal? 2. What is the satisfaction level of radiologists, surgeons, and patients with the use of the Canopus Marker? Participants will: * Have the Canopus Marker implanted into the tumor or nearby tissue using ultrasound guidance. * Undergo surgery where the Canopus Marker will help guide the surgeon to the tumor, and the marker will be removed along with the tumor. This surgery is performed using an FDA cleared and CE-marked detection device (Sirius Pintuition Detector). * Attend a follow-up visit two weeks after surgery to assess any adverse events and overall satisfaction.

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.

PARTial BREast RECONstruction With Chest Wall Perforator Flap

The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.

EVALUATION OF POSTOPERATIVE NEUROCOGNITIVE IMPAIRMENT

In this prospective study, the effects of different anesthesia methods (total intravenous anesthesia and inhaled anesthesia) on neurocognitive function will be examined in patients undergoing breast-conserving surgery without axillary lymph node dissection. Mini-Mental State Examination and Mini-Cog tests will be administered at specific intervals pre and postoperatively. Anesthesia management will follow standard protocols, and the researcher will not intervent in these processes. The relationship between the type of anesthesia and neurocognitive outcomes will be evaluated based on the collected data.