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Laser Therapy for Pain After C-Section (PBMT Trial)

N/A
Recruiting
Led By Harsha Shanthanna, MD
Research Sponsored by McMaster University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
• Women aged ≥18 years with planned C-Section under spinal anesthesia.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months

Summary

This trial is testing a light+laser device to reduce C-section pain and reduce need for medications that can affect the baby.

Who is the study for?
This trial is for women over 18 years old who are planning to have a C-section with spinal anesthesia. It's designed to help those looking for pain relief options after surgery that won't affect their baby, as traditional strong pain medications might.
What is being tested?
The study is examining the effectiveness of photo-biomodulation therapy (PBMT), which combines light and laser applied directly to the wound. The treatment will be administered twice daily to see if it reduces post-surgery pain immediately and also six weeks later.
What are the potential side effects?
While specific side effects of PBMT aren't detailed here, similar therapies sometimes cause mild skin irritation or redness at the site of application. Generally, PBMT is considered low-risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale
Secondary study objectives
Incidence of adverse effects due to PBMT
Incidence of patients with clinically important postoperative nausea/vomiting (PONV).
Incidence of persistent pain
+6 more
Other study objectives
Incidence of any adverse effects related to the use of home-based PBMT
Incidence of chronic postsurgical pain
Incidence of delayed or abnormal wound healing or surgical site infection
+1 more

Side effects data

From 2017 Phase 3 trial • 224 Patients • NCT02375971
10%
Retinal haemorrhage
9%
Pneumonia
7%
Anaemia
6%
Nasopharyngitis
6%
Dermatitis diaper
6%
Bronchopulmonary dysplasia
6%
Pyrexia
6%
Gastrooesophageal reflux disease
4%
Sepsis
4%
Retinopathy of prematurity
3%
Vomiting
3%
Apnoea
3%
Conjunctivitis
3%
Perinatal brain damage
3%
Conjunctival haemorrhage
3%
Rhinitis
3%
Urinary tract infection
3%
Inguinal hernia
1%
Osteopenia
1%
Oxygen saturation decreased
1%
Hydrocephalus
1%
Upper respiratory tract infection
1%
Pneumonia respiratory syncytial viral
1%
Respiratory failure
1%
Renal failure
1%
Pneumonia bacterial
1%
Hepatic failure
1%
Bronchitis
1%
Gastroenteritis
1%
Bronchospasm
1%
Haemodynamic instability
1%
Viral infection
1%
Cough
1%
Diarrhoea
1%
Respiratory syncytial virus bronchiolitis
1%
Atelectasis
1%
Pulmonary hypertension
1%
Respiratory symptom
1%
Wheezing
1%
Cerebral cyst
1%
Cardiac arrest
1%
Pulmonary vein stenosis
1%
Staphylococcal infection
1%
Rhinovirus infection
1%
Hydrocele
1%
Bradycardia
1%
Gastrointestinal stoma complication
1%
Cytomegalovirus infection
1%
Anaemia neonatal
1%
Tubulointerstitial nephritis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Laser
Ranibizumab 0.1 mg
Ranibizumab 0.2 mg

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ActiveExperimental Treatment1 Intervention
Application of photo-biomodulation
Group II: PlaceboPlacebo Group1 Intervention
Inactive PBMT
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Laser therapy
2013
Completed Phase 4
~990

Find a Location

Who is running the clinical trial?

McMaster UniversityLead Sponsor
917 Previous Clinical Trials
2,615,185 Total Patients Enrolled
3 Trials studying Pain
1,107 Patients Enrolled for Pain
Harsha Shanthanna, MDPrincipal InvestigatorSJHH and McMaster University
3 Previous Clinical Trials
495 Total Patients Enrolled
1 Trials studying Pain
402 Patients Enrolled for Pain
~12 spots leftby Dec 2024
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