Efficacy and Safety of Photobiomodulation for Postoperative Pain After Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversidad Nacional Autonoma de Honduras
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provided written informed consent prior to any study-related procedure.
Aged between 18 and 40 years at the time of enrollment.
Singleton pregnancy with a gestational age between 37+0 and 41+6 weeks confirmed by first-trimester ultrasound or reliable last menstrual period.
Single fetus in cephalic presentation.
Disqualifiers
Pregestational diabetes mellitus or gestational diabetes requiring insulin therapy or with inadequate glycemic control.
Medical conditions affecting normal wound healing or inflammatory response (e.g., systemic lupus erythematosus, scleroderma, immunodeficiencies, or chronic systemic corticosteroid/immunosuppressive therapy).
Active chorioamnionitis, sepsis, active systemic infection, or pre-existing skin infection at the surgical site.
Complicated cesarean delivery with operative time exceeding 90 minutes, surgical drain placement, or intraoperative organ injury.
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation Therapy (MitoQUAD® Belt System)
DeviceThe Sham Photobiomodulation Device is an inactive placebo unit designed to serve as a control intervention. It is physically identical to the active MitoQUAD® Belt system in appearance, size, shape, weight, color, timer display, audible signals, and user operation, but delivers no therapeutic red or near-infrared light energy. The sham device is applied transcutaneously over a sterile transparent dressing covering the Pfannenstiel surgical wound using the exact same treatment schedule:Session 1: Applied approximately 30 minutes post-cesarean delivery. Session 2: Applied at 24 hours post-surgery. Session 3: Applied between 36 and 48 hours post-surgery. Each session lasts 15 minutes. Participants in this control arm receive identical standard institutional post-cesarean multimodal analgesia. Application procedures, duration, and patient positioning are indistinguishable from the experimental group to maintain study blinding.
Sham Photobiomodulation Device
DeviceThe Sham Photobiomodulation Device is an inactive placebo unit designed to serve as a control intervention. It is physically identical to the active MitoQUAD® Belt system in appearance, size, shape, weight, color, timer display, audible signals, and user operation, but delivers no therapeutic red or near-infrared light energy. The sham device is applied transcutaneously over a sterile transparent dressing covering the Pfannenstiel surgical wound using the exact same treatment schedule: Session 1: Applied approximately 30 minutes post-cesarean delivery. Session 2: Applied at 24 hours post-surgery. Session 3: Applied between 36 and 48 hours post-surgery. Each session lasts 15 minutes. Participants in this control arm receive identical standard institutional post-cesarean multimodal analgesia. Application procedures, duration, and patient positioning are indistinguishable from the experimental group to maintain study blinding.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Active PhotobiomodulationExperimental treatment 1 intervention
Group B: Sham Device ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Intensity at rest at 24 Hours
Measured using the Visual Analog Scale (VAS) for pain ranging from 0 (no pain) to 10 (worst imaginable pain) while the participant is at complete rest (supine or semi-recumbent position, without movement or coughing) at 24 hours post-cesarean delivery.
Time frame
24 hours post-surgerySecondary outcomes
1
Postoperative Pain Intensity at Rest at 48 Hours
Measured using the Visual Analog Scale (VAS) for pain ranging from 0 (no pain) to 10 (worst imaginable pain) while the participant is at complete rest (supine or semi-recumbent position) at 48 hours post-cesarean delivery.
Time frame
48 hours post-surgery2
Cumulative Rescue Analgesic Consumption
Total cumulative dose of rescue NSAIDs and opioids administered during the first 48 hours post-surgery to control breakthrough pain at rest, expressed as total milligrams and number of rescue doses required.
Time frame
First 48 hours post-surgery3
Surgical Wound Healing Assessment (REEDA Scale)
Clinical evaluation of the abdominal wound using the REEDA Scale (Redness, Edema, Ecchymosis, Discharge, Approximation). Total score ranges from 0 to 15, with lower scores indicating better wound healing
Time frame
48 hours post-surgery4
Time to First Effective Ambulation
Time elapsed from the completion of cesarean surgery to the participant's first autonomous unassisted ambulation (walking at least 5 steps), measured in hours
Time frame
Up to 48 hours post-surgerySponsors and contacts
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Source ClinicalTrials.gov