The Use of Photobiomodulation for Pain and Healing in Cesarean Section
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Nove de Julho
About this trial
Good incisional wound healing and postoperative pain are the primary concerns regarding cesarean delivery, as it can lead to serious complications and delayed recovery for patients. Both pharmacological and non-pharmacological interventions have been investigated to promote effective analgesia and favorable healing of the cesarean surgical incision. Among the therapies under investigation for this purpose, photobiomodulation (PBM) stands out. Photobiomodulation consists of the use of low-intensity therapeutic light, and several publications have emphasized its analgesic properties and its capacity to promote wound healing across various etiologies. This study aims to evaluate the analgesic and wound-healing effects of PBM on the skin surgical incision following cesarean section. This will be a randomized controlled clinical trial in which 30 women undergoing elective cesarean delivery will be randomly allocated into two groups: a control group or a photobiomodulation group. All participants will receive standard hospital treatment for analgesia and postoperative wound care, combined with an active PBM protocol consisting of 3 J per point (658 nm) applied to the incisional area and 4.5 J per point (830 nm) applied around the wound, delivered immediately postoperatively, as well as 24 and 48 hours after surgery. The control group will undergo PBM with the laser device turned off, using the same protocol. Patients will be assessed before and after each PBM session, at 24 and 48 hours, and at 5, 10, and 40 days postpartum, to evaluate pain intensity using the Visual Analog Scale (VAS) and the McGill Pain Questionnaire, as well as wound healing using the REEDA scale. Clinical wound characteristics, epidemiological data, analgesic consumption during the inpatient period, and the occurrence of adverse events will be used as secondary outcomes. A two-way repeated-measures ANOVA will be used for comparisons between groups and across time points.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women undergoing cesarean section, regardless of whether indicated during labor or electively by maternal request;
Under follow-up at the Mandaqui Hospital Complex "Bispa Keila Campos Costa Ferreira" by the local Obstetrics team;
Admitted to the Hospital for delivery (either by referral or spontaneous demand) with adequate prenatal care (minimum of 7 visits);
Aged between 18 and 45 years;
Disqualifiers
Women with multiple gestation;
Women with uncontrolled systemic diseases;
Women with active infectious conditions as an indication for pregnancy resolution (e.g., patients with chorioamnionitis);
Women with a prior diagnosis of coagulation disorders;
Trial design
Design model
Parallel
Treatments tested in this trial
Photobiomodulation (PBM)
RadiationPBM device with an output power of 100 W, equipped with a Red Laser probe (658 nm) delivering 3 Joules per point over 6 points along the incision, and an Infrared probe (830 nm) delivering 4.5 Joules per point, applied to as many points as necessary to cover the entire perimeter around the incision, with a 1-cm distance between each point and from the incision itself.
Placebo PBM
RadiationPBM device switched off
Standard Hospital Treatment
Other interventionStandard individualized analgesic and wound-healing treatment for the surgical incision, as routinely provided by the hospital's healthcare team, under the coordination and evaluation of the patients' routine clinical care staff. The women will remain under the clinical routine prescribed by their attending medical team.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Treatment GroupActive comparator 2 interventions
Group B: Controlled GroupPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Pain Intensity
The presence of pain in the cutaneous reference region of the cesarean wound will be assessed using a Numerical Pain Scale (NPS) / The NPS is an aid in measuring the intensity of pain felt by the patient, an important instrument to verify progress and analyze the treatment instituted. The participant should be asked about their level of pain, where 0 means total absence of pain and 10 the maximum pain level.
Time frame
Baseline" or "Day 1" , immediately after cesarean, immediately before and PBM session on 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean2
Intensity Pain
The presence of pain in the cutaneous reference region of the cesarean wound will be assessed using a McGill Pain Questionnaire (Brazilian Portuguese validated version).
Time frame
Time Frame: Baseline" or "Day 1" , immediately after cesarean, 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean3
Cesarean Wound Healing
Edema and local wound healing will be assessed using the REEDA scale (Hill, 1990), which evaluates the inflammatory process and tissue repair following perineal trauma. Five healing parameters are assessed: redness, edema, ecchymosis, discharge, and approximation of wound edges (coaptation). Each item is scored from 0 to 3 by the evaluating clinician, with a maximum total score of 15 points indicating the poorest wound healing.
Time frame
24 and 48 hours after cesarean, and 05, 10 and 40 days after cesareanSecondary outcomes
1
Amount of analgesic medications used (dosage, mg, and regimen)
For the inpatient phase, this information will be extracted directly from the participants' medical records, as these data are routinely collected by the clinical care team. After hospital discharge, this information will be collected via telephone at 5, 10, and 40 days post-procedure, through an anamnesis/video consultation with the participants.
Time frame
Immediately after cesarean, 24 and 48 hours after cesarean, and 5, 10, and 40 days post-procedure,2
Occurrence of postoperative complications
For the inpatient phase, this information will be collected on-site by the research team. After hospital discharge, this information will be collected via telephone through an anamnesis/video consultation with the participants. During the video consultation, a visual assessment of the surgical incision's progression will be performed to investigate the following complications: Inflammatory signs (flogistic signs); Presence of pus; Presence of moisture/exudate; Presence of granulation tissue; Incisional bulging/raised areas; Local edema; Local hyperemia; Suture dehiscence; Local hematoma; Incisional bleeding; Local discharge/exudate; Scar fistulization; Scar retraction/contracture; Suture loss (missing stitches); Orange-peel edema (peau d'orange).
Time frame
Baseline" or "Day 1" , immediately after cesarean, 24 and 48 hours after cesarean, and 05, 10 and 40 days after cesarean3
Functionality
This information will be collected via telephone interview through an anamnesis with the participants. The following questions will be asked: Are you able to hold your baby in your arms while standing? Are you able to take a shower standing up by yourself? Are you able to go up and down stairs or steps? Have you experienced any discomfort during bowel movements?
Time frame
5, 10, and 40 days post-procedure4
Adverse effects
Any adverse effect related to PBM founded after study will be report
Time frame
immediately postoperatively, as well as 24 and 48 hours after surgery.Locations
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Source ClinicalTrials.gov
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