Clinical Research Directory

Comparison of Lidocaine With and Without Adrenaline for Reducing Ecchymosis

This randomized, double-blinded controlled trial evaluates whether lidocaine with adrenaline reduces bruising (ecchymosis) more effectively than lidocaine without adrenaline among women undergoing contraceptive implant insertion or removal at King Chulalongkorn Memorial Hospital. Bruising is common after these procedures and may contribute to stigma and concealment behaviors; adrenaline's vasoconstrictive effect may lessen bleeding, prolong anesthesia, and reduce bruising, but the two formulations have not been directly compared in this setting. A total of 450 women aged ≥18 years will be enrolled and randomized 1:1 (sealed opaque envelopes) to receive either lidocaine with adrenaline or lidocaine without adrenaline during implant insertion or removal. Participants and outcome assessors will be blinded. During the procedure, blood loss, heart rate, blood pressure, and pain will be recorded. Post-procedure follow-up lasts 7 days: participants submit standardized photos of the procedure site via Line OA on Day 3 and Day 7 for bruise assessment and report pain onset and satisfaction with wound appearance/healing. Risks include transient effects potentially related to adrenaline (e.g., restlessness, palpitations, flushing, dizziness, brief increases in heart rate or blood pressure) and typical minor procedure-related effects (pain, mild bleeding, temporary discomfort). Vital signs will be monitored before and up to 30 minutes after anesthetic administration. Photo submission carries minimal privacy risk; images and data will be coded and stored securely with access limited to authorized personnel. If an adverse event is related to study participation and instructions were followed, medical costs and reasonable loss-of-time compensation will be covered. No insurance is provided. No direct benefit to participants is expected, but findings may improve clinical practice by reducing bruising and enhancing patient satisfaction with contraceptive implant services. Participation is voluntary; withdrawal is permitted at any time without affecting medical care. Collected data will be anonymized; investigators, the sponsor, and authorized ethics/regulatory bodies may review records as permitted by law. Data will be destroyed after study completion; no biological samples will be stored. Principal investigator contact: Assoc. Prof. Somsook Santibenchakul, MD, PhD, MPH, Department of Obstetrics and Gynecology, King Chulalongkorn Memorial Hospital, 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand; dr.somsook@gmail.com * Ethics inquiries: Research Ethics Committee, Faculty of Medicine, Chulalongkorn University, Ananda Mahidol Building, 3rd Floor, King Chulalongkorn Memorial Hospital, 1873 Rama IV Road, Pathumwan, Bangkok 10330, Thailand; +66 2 256 4493; medchulairb@chula.ac.th

Bridging the Healing Gap: A Single-Blind Clinical Trial Assessing the Efficacy of Carboxy-gel in Reducing Bruising and Pain Post-Liposuction

The goal of this clinical trial is to evaluate if CO2 Lift reduces bruising and pain after Liposuction. The study also aims to explore changes in patient satisfaction. The main questions this study seeks to answer are: * Does CO2 lift reduce the extent of bruising at 7 days post-surgery? * How does CO2 lift impact patient-reported pain and satisfaction? In this study, researchers will compare CO2 lift to a placebo (Vaseline) to see if the intervention has a positive effect. The study procedures include: * Baseline data collection of sociodemographic variables. Data collection of surgical variables, adverse events, pain scores, and satisfaction scores. * During the liposuction procedure the patient will receive CO2 Lift application to one arm, and/or one glute, and/or one half of the lower abdomen, and placebo (Vaseline) to the contralateral part. * Apply CO2 lift and Vaseline immediately after surgery, 12 hours later, and then once a day for 3 to 5 days depending of the risk of the flap/skin. * Postoperative follow-up with photos of treated areas at 24 hours, 3 days, and 7 days, with bruising quantified using Image J software.

The Effect of Chilled Needle on the Development of Pain and Ecchymosis in Subcutaneous Injection in Adults

Subcutaneous (SC) injection applications are the process of administering the drug to the loose connective tissue under the skin and is one of the most frequently applied parenteral drug administration methods among nursing practices. SC injections, which are frequently performed by nurses, often result in complications such as hematoma, ecchymosis and pain at the injection site. Although the field of healthcare is developing day by day, injection applications can still be painful and uncomfortable. These procedures increase the individual's stress levels before the procedure, causing them to experience fear and anxiety and reducing patient satisfaction. This may cause the application to fail or be repeated. Many nonpharmacological methods are applied to prevent or reduce these local side effects in subcutaneous injection applications. Cold application is accepted as an effective and easy-to-use method for SC injection. Cold application may also constrict peripheral blood vessels, reducing blood flow to the tissue and thus preventing ecchymosis. When the national and international literature is examined, there are studies using cold application to reduce pain and ecchymosis due to SC injection in adults. This study aimed to evaluate the effectiveness of cold injection, which is considered an alternative to cold therapy, in reducing pain and ecchymosis due to SC injection application. No study has been found in the literature evaluating the effectiveness of cold injection in preventing pain and ecchymosis due to SC injection application. Therefore, it is thought that this study will make a significant contribution to the literature and create a simple, comfortable and cost-free innovation. Preparation and use of cold injection is simple, easy and comfortable. It is anticipated that patients will be able to easily follow the procedure steps during the procedure. Therefore, this study aimed to examine the effect of the cooled needle on the development of pain and ecchymosis in SC injection application in adults.