Postoperative Pain After Cesarean SectionBIOLUZCENCT07863960
Efficacy and Safety of Photobiomodulation for Postoperative Pain After Cesarean Section
A study testing Photobiomodulation Therapy (MitoQUAD® Belt System) in people with Postoperative Pain After Cesarean Section, run by Universidad Nacional Autonoma de Honduras at 1 site in Honduras.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain After Cesarean Section
- What is being tested?
- Photobiomodulation Therapy (MitoQUAD® Belt System)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteHonduras
- Study dates
- 1 Oct 2026to 1 Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Scheduled or emergency primary or repeat low-transverse segment cesarean section (maximum 1 prior cesarean delivery) performed via Pfannenstiel incision.
- Received neuraxial anesthesia (spinal, epidural, or combined spinal-epidural) according to institutional protocol.
- Skin closure executed using standardized technique (absorbable intradermal suture, nylon, or surgical staples).
Who cannot join
- 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.
- History of severe keloid formation or known abdominal hypertrophic scarring disorders.
- Chronic pain syndromes, fibromyalgia, chronic opioid use, or history of substance abuse.
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- Intraoperative conversion to general anesthesia or failure of planned neuraxial anesthesia.
- Body Mass Index (BMI) ≥ 40 kg/m² at late pregnancy.
- Known hypersensitivity or allergy to materials used in the photobiomodulation device or dressing.
- Concurrent participation in another clinical trial or receipt of an investigational product within 30 days prior to enrollment.
- Any significant medical, obstetric, or psychiatric condition that, in the judgment of the Principal Investigator, could compromise participant safety or protocol compliance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Honduras1 site, 1 recruiting
- Recruiting
Hospital Escuela
Tegucigalpa, Francisco Morazán Department
Ricardo Arturo Gutierrez Ramirez, MD, MSc., 97546940, ricardo.gutierrez@unah.edu.hn
Maria F. Díaz Álvarez, MD
About this study
Official title: Efficacy and Safety of Photobiomodulation on Postoperative Pain in Postpartum Women Undergoing Cesarean Section at Hospital Escuela and IHSS Tegucigalpa, Honduras: A Randomized, Double-Blind, Sham-Controlled Clinical 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.
Read the detailed description
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.
- Being tested
- Photobiomodulation Therapy (MitoQUAD® Belt System), Sham Photobiomodulation Device
- Keywords
- Photobiomodulation, Low-Level Light Therapy, Postpartum Pain, Cesarean Delivery, Multimodal Analgesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation Therapy (MitoQUAD® Belt System)Device
Also called 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.
Sham Photobiomodulation DeviceDevice
Also called Inactive Placebo Light Therapy 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.
| Study group | Role | What they receive |
|---|---|---|
| Active Photobiomodulation | Experimental | 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. Receives: Device: Photobiomodulation Therapy (MitoQUAD® Belt System) |
| Sham Device Control | Sham comparator | 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. Receives: Device: Sham Photobiomodulation Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours post-surgery
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Up to 48 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Oct 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain After Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, single-center, randomized, double-blind, sham-controlled, 2-arm parallel-group superiority clinical trial. Eligible postpartum women undergoing cesarean section are randomized in a 1:1 allocation ratio to receive either active photobiomodulation (MitoQUAD® Belt) or an inactive sham device, as an adjunct to standard multimodal analgesia. Randomization is generated using REDCap® central randomization software with permuted block sizes to guarantee allocation concealment. Participants in both arms receive three 15-minute device applications (at 30 minutes, 24 hours, and 36-48 hours post-cesarean). Quadruple masking is strictly enforced: participants, attending clinical staff, investigators, and outcome assessors are fully blinded to treatment allocation. The sham device is physically identical to the active unit in size, shape, weight, display, and operation.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional Autonoma de Honduras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo A Gutierrez Ramirez, MD, MSc, FACOG, Universidad Nacional Autonoma de Honduras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07863960
- Sponsor's protocol ID
- PGO-UNAH-49-11-2026
- Acronym
- BIOLUZCE
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
de Holanda Araujo AMP, de Sena KRR, da Silva Filho EM, Pegado R, Micussi MTABC. Low-level laser therapy improves pain in postcesarean section: a randomized clinical trial. Lasers Med Sci. 2020 Jul;35(5):1095-1102. doi: 10.1007/s10103-019-02893-3. Epub 2019 Oct 28.
PubMed 31659541