The Use of Photobiomodulation for Pain and Healing in Cesarean Section

The Use of Photobiomodulation for Pain and Healing in Cesarean Section: A Randomized, Controlled Clinical 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.

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. We also foresee a pilot interim analysis when recruitment reaches a size of 10 participants per group. This interim analysis will be performed using a two-way/means ANOVA to assess effect size and recalculate sample size, making adjustments to the design if necessary.

Inclusion Criteria:

• 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;
• Have undergone adequate prenatal follow-up;
• Have a mobile phone with internet access and a video-calling application.

Exclusion Criteria:

• 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;
• Women with grade 3 obesity (BMI ≥ 40 kg/m²);
• Women with photosensitivity;
• Women with more than 2 previous cesarean sections (repeated/recurrent cesareans).
• Women who, at the time of delivery, did not receive intraoperative prophylactic antibiotic therapy, who present secondary skin lesions from recent local shaving/trichotomy, or who were not submitted to preoperative surgical site degerming/preparation (all of which are measures that impact the reduction of surgical site infection risk);
• Parturients who presented clinical complications during the immediate pre-hospital, intra-hospital, or intrapartum period.