This study was a prospective, double-blind clinical trial that was conducted during the period of 2014 - 2013. Groups of patients were selected among the admitted patients for elective cesarean from Imam Khomeini hospital in Ahvaz, Iran. Setting the power at 80% and the values for α, β, Zα, and Zβ at 0.05, 0.2, 1.96, and 0.84, respectively, the sample size was calculated to include 40 subjects in each of the case and control groups. After approval of the Ethics Committee of Ahvaz Jundishapur University of Medical Sciences (ajums.rec.1392.40) and written consent was taken from 80 pregnant women between 40 - 18 years, women with their first or second pregnancy and the American Society of Anesthesiologists (ASA) classes I and II were candidates for elective cesarean and were selected as the inclusion criteria of study. The subjects were randomly divided into two groups of 40 individuals for laser and controlled groups through a computer - generated list of random numbers. The exclusion criteria of the study included individuals determined as the patients with previous classical incision, malignancy, benign tumors with the possibility to become malignant, sensitivity to light such as lupus, history of epilepsy or seizure, the patient's refusal of spinal anesthesia, elevated ICP, coagulopathy, infection of the skin or soft tissue around the insertion of the needle, and peripheral neuropathy of lower limb. After arriving to the operating room, patients received 10 mL/kg Ringer's lactate solution. Monitoring equipment employed were electrocardiogram, pulse oximetry, and sphygmomanometer; spinal anesthesia was done with 12 mg bupivacaine 0.5% (Astrazeneca Co. Germany) in the sitting position at the L4 - L5 space with midline technique. After ensuring the neuroxial block with the lack of sense with the tip of a needle at dermatome T4, the patients were operated as by Pfannenstiel incision.
During operation, at 5 minute intervals, systolic and diastolic blood pressure, oxygen saturation, and heart rate were monitored.
The treatment were done in the surgery room after the end of surgery and before the bandage. Laser group was treated with the combination of IR and red lasers (PLP-IR 808 nm - 200 mW, PLP-R 650 nm - 100 mW). For the control group, lasers were set to “off” during the treatment as placebo. Lasers were designed and manufactured by Canadian optic and laser center (COL Center). The power density for red laser was 0.1 W/cm
2 and for IR laser was 0.2 W/cm
2 (
Figures 1 and
2).
The points and locations irradiated in patients
Laser radiation to surgical site
The incisions were treated by the red laser, 1 J/cm2 for 10 seconds, and IR laser, 2 J/cm2 for 10 seconds. The total combination dose was 3 J/cm2 (1 J Red + 2 J IR) on the surgical suture. The size of the incisions was between 7 - 10 cm2, therefore, the total energy was between 21 - 30 J, depending on the size of the incision line.
The surrounding tissue was treated with the same combination of lasers with the interval of 2 cm, three points above and three points below the suture and each point’s area was equal 1 cm2. Each point was treated for 15 seconds by Red and IR. The total dose for each point was 4.5 J/cm2 (3 J IR + 1.5 J Red), and the total energy was 27 J.
The patients and anesthesia resident who completed the questionnaires were blinded to the patient groups and did not know the study groups. Only the operator of the LLL was aware of the study group. Considering the end of anesthesia, as the onset of pain through Visual Analogue Scale (VAS), a measure, which is considered the least pain equal to zero and the worst imaginable pain of 10, were examined at 1, 4, 8, 12, 16, and 24 hours and they received intravenous Pethidine 0.3 mg/kg in the presence of pain with VAS equal to three or greater than that. The severity of postoperative pain, first request of tranquilizer, and total consumed Pethidine after 24 hours were recorded in the questionnaire by the assistant of anesthesia who didn’t know about patient groups. Side effects including nausea, vomiting, dizziness, and hypotension were also studied at stated hours.
2.1. Statistical Methods
Data were reported as the mean ± standard deviation (SD). In order to compare the groups after analyzing the normal distribution and homogeneity of variances, the Independent sample t-test, repeated measure test, and Bonferroni post hoc test were applied. Significant level of data was considered as P < 0.05. Statistical analyses were performed using SPSS software (version 16).