Photobiomodulation to help pain after cesarean delivery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind, sham-controlled trial, postpartum women undergoing cesarean delivery receive three 15-minute sessions of active photobiomodulation or sham treatment within 48 hours after surgery, in addition to standard multimodal analgesia. The goal is to see if red and near-infrared light from the MitoQUAD belt reduces pain scores, lowers rescue analgesic use, aids wound healing, and speeds ambulation. Primary and secondary outcomes include pain intensity, analgesic use, wound healing, time to ambulation, maternal satisfaction, and adverse events. The study is conducted at Hospital Escuela in Tegucigalpa, Honduras, enrolling 210 participants aged 18–40. It is designed as a parallel-group, superiority trial with centralized randomization and sham control.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Escuela
  Tegucigalpa, Francisco Morazán Department, Honduras Recruiting

Study contacts

• Study coordinator: Ricardo A. Gutierrez-Ramirez, MD, MSc
• Email: ricardo.gutierrez@unah.edu.hn
• Phone: 97546940

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Interferential Current vs TENS for Pain After Cesarean Section

  This study tests whether interferential current therapy or conventional TENS can reduce pain and improve comfort after cesarean delivery, compared with placebo, in first-time mothers.

  Recruiting Muğla Sıtkı Koçman University · Muğla · NCT07847502

• Predictors of severe pain within 24 hours after cesarean delivery with spinal anesthesia

  This study will look at which pre-, intra-, and post-operative factors are linked to severe pain in the first 24 hours after an elective cesarean done with spinal anesthesia.

  Recruiting Bursa City Hospital · Bursa, Nilüfer · NCT07789301

• Combined spinal-epidural versus erector spinae plane block for pain after elective cesarean

  We will test whether an erector spinae plane block provides as much or better postoperative pain relief than combined spinal-epidural analgesia for women undergoing elective cesarean section.

  Recruiting Bursa City Hospital · Bursa, Nilüfer · NCT07411521

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.