NCT05738239

Brief Summary

C-sections may result in a lot of pain that is distressing to the mother, and can impact bonding with the baby. Although there are medications used to treat strong pain, they are not good to use after C-sections because they can affect the baby. There is a need for a pain management option that can reduce the use of medications. The investigators are testing the effects of a combined light and laser device (photo-biomodulation therapy; PBMT), used on the wound twice daily, with respect to pain right after surgery, and pain that lasts longer than 6 weeks after surgery.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable pain

Timeline
Completed

Started Sep 2023

Longer than P75 for not_applicable pain

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

January 27, 2023

Last Update Submit

September 16, 2025

Conditions

Pain

Keywords

Postoperative wound painCaesarean sectionPhoto-biomodulation therapyLow-level LASERChronic post-surgical pain

Outcome Measures

Primary Outcomes (7)

  • Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale

    The 0-10 Numerical Rating Scale (NRS) (0=no pain, 10=worst possible pain, patient reported.

    Evening of surgery (8-9 pm)

  • Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale

    The 0-10 Numerical Rating Scale (NRS) (0=no pain, 10=worst possible pain, patient reported.

    Postoperative day 1, morning (9-10 am)

  • Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale

    The 0-10 Numerical Rating Scale (NRS) (0=no pain, 10=worst possible pain, patient reported.

    Postoperative day 1, noon (12-1 pm)

  • Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale

    The 0-10 Numerical Rating Scale (NRS) (0=no pain, 10=worst possible pain, patient reported.

    Postoperative day 1, evening (8-9 pm)

  • Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale

    The 0-10 Numerical Rating Scale (NRS) (0=no pain, 10=worst possible pain, patient reported.

    Postoperative day 2, morning (9-10 am)

  • Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale

    The 0-10 Numerical Rating Scale (NRS) (0=no pain, 10=worst possible pain, patient reported.

    Postoperative day 2, noon (12-1 pm)

  • Pain intensity with movement (elicited by asking the patient to move from supine to sitting position) using 0-10 Numerical Rating Scale

    The 0-10 Numerical Rating Scale (NRS) (0=no pain, 10=worst possible pain, patient reported.

    Postoperative day 2, evening (8-9 pm)

Secondary Outcomes (10)

  • Pain scores at rest

    7 time points: evening of surgery (8-9 pm); POD 1 and 2 at morning (9-10 am), noon (12-1 pm), and evening (8-9 pm).

  • The percentage of patients with moderate and severe pain

    Average of pain scores from 7 time points: evening of surgery (8-9 pm); POD 1 and 2 at morning (9-10 am), noon (12-1 pm), and evening (8-9 pm).

  • Total opioid dose used in hospital

    3 days: Day of surgery until discharge from hospital

  • Incidence of patients with clinically important postoperative nausea/vomiting (PONV).

    3 days: Day of surgery until discharge from hospital at 7 time points: evening of surgery (8-9 pm); POD 1 and 2 at morning (9-10 am), noon (12-1 pm), and evening (8-9 pm).

  • Incidence of severe sedation

    3 days: Day of surgery until discharge from hospital at 7 time points: evening of surgery (8-9 pm); POD 1 and 2 at morning (9-10 am), noon (12-1 pm), and evening (8-9 pm).

  • +5 more secondary outcomes

Other Outcomes (4)

  • Incidence of chronic postsurgical pain

    3 months postoperatively

  • Incidence of delayed or abnormal wound healing or surgical site infection

    3 months

  • Incidence of postpartum depression

    3 months

  • +1 more other outcomes

Study Arms (2)

Active

EXPERIMENTAL

Application of photo-biomodulation

Device: Laser therapy

Placebo

PLACEBO COMPARATOR

Inactive PBMT

Device: Laser therapy

Interventions

Laser therapyDEVICE

Biological effects of low-level LASER therapy have been studied for various clinical indications, including musculoskeletal conditions and some acute pain conditions. PBMT includes low level LASER (works on pain) and light-emitting diodes (LED) (works on wound healing).

ActivePlacebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged ≥18 years with planned C-Section under spinal anesthesia.

You may not qualify if:

  • Not willing
  • Language barrier or cannot communicate in English.
  • History of chronic ongoing pain needing daily opioid medications
  • High risk or twin/multiple pregnancy
  • C-Section planned under a general anesthetic.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Related Publications (2)

  • Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24.

    PMID: 18818022RESULT

  • Cheng K, Martin LF, Slepian MJ, Patwardhan AM, Ibrahim MM. Mechanisms and Pathways of Pain Photobiomodulation: A Narrative Review. J Pain. 2021 Jul;22(7):763-777. doi: 10.1016/j.jpain.2021.02.005. Epub 2021 Feb 23.

    PMID: 33636371RESULT

MeSH Terms

Conditions

PainPain, Postoperative

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Harsha Shanthanna, MD

    SJHH and McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Active PBMT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 22, 2023

Study Start

September 1, 2023

Primary Completion

December 31, 2025

Study Completion

February 1, 2026

Last Updated

September 22, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)