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Efficacy and Safety of Photobiomodulation for Postoperative Pain After Cesarean Section

Study acronym: BIOLUZCE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
Postoperative pain following cesarean section remains a major clinical challenge that can impair early maternal recovery, delay ambulation, and interfere with newborn care. Photobiomodulation (PBM) is a non-invasive light therapy that uses red and near-infrared light to reduce inflammation, stimulate cellular energy (ATP) production, and promote tissue repair. The purpose of this randomized, double-blind, sham-controlled clinical trial is to evaluate the efficacy and safety of portable photobiomodulation using the MitoQUAD® device as an adjunct to standard multimodal analgesia in postpartum women undergoing cesarean section. Participants (N=210) will be randomized (1:1) to receive either active PBM or a sham device in three 15-minute sessions (at 30 minutes, 24 hours, and 36-48 hours post-cesarean). Pain intensity, rescue analgesic use, wound healing, time to ambulation, maternal satisfaction, and adverse events will be monitored over 48 hours.
Trial Details
NCT Number NCT07863960
Lead Sponsor Universidad Nacional Autonoma de Honduras
Conditions
(from sponsor)
Postoperative Pain After Cesarean Section
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov