Effects of Photobiomodulation With Red and Infrared Low-level Laser Diodes in Individuals Undergoing Rhinoplasty at a Single Centre: Protocol for a Randomized, Double-blind, Controlled Clinical Trial
This single-centre, randomized, double-blind, sham-controlled clinical trial evaluates whether preoperative photobiomodulation (PBM) with red and infrared light can reduce early postoperative periorbital edema in patients undergoing primary open rhinoplasty with osteotomies. Sixty participants will be randomly assigned to receive active PBM or sham PBM one hour before surgery. The primary outcome is periorbital edema on postoperative day 3 measured using a validated ordinal clinical scale with standardized photographic documentation. Secondary outcomes include ecchymosis, postoperative pain, analgesic consumption, nasal tip skin thickness, and patient-reported functional and aesthetic outcomes. Participants will be followed for up to 12 months after surgery.
• individuals 18-60 years of age;
• ASA I or II; no comorbidities (no pre-existing diseases);
• indication for rhinoplasty;
• regardless of gender identity.