Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT07863960

Efficacy and Safety of Photobiomodulation for Postoperative Pain After Cesarean Section

Sponsor: Universidad Nacional Autonoma de Honduras

View on ClinicalTrials.gov

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 (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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2026-10-01

Completion Date

2027-02-01

Last Updated

2026-10-07

Healthy Volunteers

Yes

Conditions

Postoperative Pain After Cesarean Section

Interventions

DEVICE

Photobiomodulation Therapy (MitoQUAD® Belt System)

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.

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.

Inclusion Criteria: 1. Provided written informed consent prior to any study-related procedure. 2. Aged between 18 and 40 years at the time of enrollment. 3. Singleton pregnancy with a gestational age between 37+0 and 41+6 weeks confirmed by first-trimester ultrasound or reliable last menstrual period. 4. Single fetus in cephalic presentation. 5. Scheduled or emergency primary or repeat low-transverse segment cesarean section (maximum 1 prior cesarean delivery) performed via Pfannenstiel incision. 6. Received neuraxial anesthesia (spinal, epidural, or combined spinal-epidural) according to institutional protocol. 7. Skin closure executed using standardized technique (absorbable intradermal suture, nylon, or surgical staples). Exclusion Criteria: 1. Pregestational diabetes mellitus or gestational diabetes requiring insulin therapy or with inadequate glycemic control. 2. Medical conditions affecting normal wound healing or inflammatory response (e.g., systemic lupus erythematosus, scleroderma, immunodeficiencies, or chronic systemic corticosteroid/immunosuppressive therapy). 3. Active chorioamnionitis, sepsis, active systemic infection, or pre-existing skin infection at the surgical site. 4. Complicated cesarean delivery with operative time exceeding 90 minutes, surgical drain placement, or intraoperative organ injury. 5. History of severe keloid formation or known abdominal hypertrophic scarring disorders. 6. Chronic pain syndromes, fibromyalgia, chronic opioid use, or history of substance abuse. 7. Intraoperative conversion to general anesthesia or failure of planned neuraxial anesthesia. 8. Body Mass Index (BMI) ≥ 40 kg/m² at late pregnancy. 9. Known hypersensitivity or allergy to materials used in the photobiomodulation device or dressing. 10. Concurrent participation in another clinical trial or receipt of an investigational product within 30 days prior to enrollment. 11. Any significant medical, obstetric, or psychiatric condition that, in the judgment of the Principal Investigator, could compromise participant safety or protocol compliance.

Locations (1)

Hospital Escuela

Tegucigalpa, Francisco Morazán Department, Honduras