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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

Status: Recruiting
Location: See location...
Intervention Type: Device, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• individuals 18-60 years of age;

• ASA I or II; no comorbidities (no pre-existing diseases);

• indication for rhinoplasty;

• regardless of gender identity.

Locations
Other Locations
Brazil
Hospital Paulista de Otorrinolaringologia
RECRUITING
São Paulo
Contact Information
Primary
Cinthya CG Duran, PhD
cinthya.cgduran@gmail.com
5511981628831
Time Frame
Start Date: 2026-01-30
Estimated Completion Date: 2030-11-30
Participants
Target number of participants: 60
Treatments
Experimental: Photobiomodulation Group
Participants will receive active photobiomodulation (PBM) one hour before rhinoplasty, in addition to standard surgical and perioperative care.
Sham_comparator: Simulation of Photobiomodulation Group
Participants will receive a sham photobiomodulation procedure one hour before rhinoplasty, in addition to standard surgical and perioperative care.
Related Therapeutic Areas
Sponsors
Leads: University of Nove de Julho

This content was sourced from clinicaltrials.gov