An interventional study of Photobiomodulation Therapy (MitoQUAD® Belt System) and Sham Photobiomodulation Device in Postoperative Pain After Cesarean Section, sponsored by Universidad Nacional Autonoma de Honduras. Recruiting at 1 site in Honduras. Open to female participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Universidad Nacional Autonoma de Honduras · Not applicable, Interventional, and Treatment
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.
Cesarean delivery is associated with significant postoperative pain originating from both somatic abdominal wall trauma and visceral uterine traction. Standard pharmacologic management relies heavily on NSAIDs, acetaminophen, and opioids; however, opioids carry risks of sedation, nausea, constipation, and potential neonatal exposure via breastfeeding. Photobiomodulation (PBM) uses low-level light in red (630-660 nm) and near-infrared (810-850 nm) spectrums to activate mitochondrial cytochrome c oxidase, boosting ATP synthesis, modulating inflammatory cytokines (TNF-α, IL-1β, IL-6), and accelerating collagen synthesis and re-epithelialization. This single-center, randomized, double-blind, sham-controlled, parallel-group, superiority trial will enroll 210 postpartum women aged 18-40 undergoing elective or emergency cesarean delivery via Pfannenstiel incision under neuraxial anesthesia at Hospital Escuela in Tegucigalpa, Honduras. Eligible participants who provide written informed consent will be randomized 1:1 via REDCap® central randomization into two groups:Active PBM Group (n=105): Receives three 15-minute applications of the MitoQUAD® Belt device (emitting 630 nm, 660 nm, 810 nm, and 850 nm at 13.28 mW/cm²) placed over a sterile transparent dressing covering the surgical wound. Sham Control Group (n=105): Receives three 15-minute applications of an inactive sham device identical in physical appearance, timer display, and user operation. Application Schedule: Session 1 at 30 minutes post-surgery; Session 2 at 24 hours; Session 3 between 36-48 hours post-surgery. Both groups receive identical institutional multimodal analgesia. Primary outcome is pain intensity during movement at 24 hours post-surgery measured via Visual Analog Scale (VAS 0-10). Secondary outcomes include VAS pain at rest (24h, 48h) and movement (48h), cumulative rescue analgesic consumption (mg and doses), wound healing evaluated by the REEDA scale at 48 hours, time to first autonomous ambulation (hours), maternal childbirth experience evaluated by the CEQ2 questionnaire at discharge, and safety outcomes. Analyses will follow the Intention-To-Treat (ITT) principle.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
This study's planned enrollment of 210 is above the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Universidad Nacional Autonoma de Honduras is the lead sponsor of 13 studies on the registry; 8 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
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BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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Hypersensitivity
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Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive active photobiomodulation therapy using the MitoQUAD® Belt device placed over a sterile transparent dressing covering the Pfannenstiel surgical incision. Treatment consists of three 15-minute sessions applied at 30 minutes post-surgery, 24 hours post-surgery, and between 36-48 hours post-surgery, in addition to standard multimodal analgesia.
Device: Photobiomodulation Therapy (MitoQUAD® Belt System)
Participants receive a sham intervention using a inactive device externally identical in appearance, weight, dimensions, and operational interface to the active device. The sham device is applied over the surgical incision on the same 3-session schedule (15 minutes each at 30 min, 24 h, and 36-48 h post-cesarean), in addition to standard multimodal analgesia.
Device: Sham Photobiomodulation Device
The 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.
Also known as: Low-Level Light Therapy (LLLT), MitoQUAD Belt, Red and Near-Infrared LED Therapy
The 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.
Also known as: Inactive Placebo Light Therapy Device
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-surgery
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-surgery
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-surgery
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-surgery
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-surgery
Maternal Childbirth Experience and Satisfaction (CEQ2)
Maternal satisfaction with pain management and overall childbirth experience evaluated at hospital discharge using the Childbirth Experience Questionnaire version 2 (CEQ2)
Time frame: At hospital discharge (approximately 48 hours post-surgery)
Incidence of Treatment-Emergent Adverse Events
Frequency, severity, and causality of local adverse events (eruthema, skin irritation, thermal discomfort, burns) and systemic adverse events recorded during the trial
Time frame: Up to 48 hours post-surgery
Plan to share: Yes — De-identified individual participant data (IPD) collected during the trial, including primary pain scores, rescue analgesic consumption, REEDA wound scores, time to ambulation, and safety endpoints, will be made available upon reasonable academic request.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will become available beginning 6 months following primary publication of the trial results and will remain accessible for 3 years.
Access criteria: Data will be shared with qualified academic researchers for methodologically sound research proposals approved by an independent review committee. Proposals must be submitted directly to the Principal Investigator via email (ricardo.gutierrez@unah.edu.hn). Requestors must execute a formal Data Use Agreement (DUA).
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Universidad Nacional Autonoma de Honduras