Clinical Research Directory

Comparison of Lidocaine With and Without Adrenaline for Reducing Ecchymosis

Sponsor: Chulalongkorn University

Summary

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

Official title: The Effect of Lidocaine With Adrenaline Versus Lidocaine Without Adrenaline on Reducing Ecchymosis in Women Undergoing Contraceptive Implant Insertion and Removal: A Randomized Double-Blinded Controlled Trial

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