Background Data regarding the analgesic effects of melatonin after the surgery is scare. So far, only one study has investigated the analgesic effect of melatonin during cesarean section. Objective : The present study was performed to investigate the effect of preoperative oral melatonin on pain intensity after cesarean section during spinal anesthesia. Methods In a double-blind randomized controlled clinical trial study, 204 patients undergoing elective cesarean section with class 1 and 2 anesthesia (ASA) were enrolled. Patients were randomly divided into 3 groups of 68 patients. Patients in group A were given 5 mg melatonin tablets, patients in group B were given 10 mg melatonin tablets, and group C was given placebo. All patients underwent spinal anesthesia with the same anesthesia protocol. Pain intensity, nausea, vomiting, pruritus and headache were assessed and recorded 2, 6, 12 and 24 h after surgery. The time of first dose of analgesia, the amount of opioid consumed within 24 h, and the time to resume physical activity was also recorded. Statistical analysis of data was performed using SPSS 20 software. Results Repeated measurements of pain intensity during the study showed that in all 3 groups pain intensity was significantly reduced during the study, p < 0.001, respectively. The intensity of pain was significantly different in groups B and C, groups B and A and groups A and C, P < 0.001, respectively. The pain reduction was greatest in group B, followed by group A and group C, respectively. The time interval between the end of surgery and the patient's need for analgesia was significant in group B compared to group A (P = 0.035) and C (P < 0.001) and also in group A compared to group C (P = 0.011). The mean dose of opioid was significantly least in group B, p < 0.001. The mean time to resume physical activity was also shortest in group B, p < 0.001 Headache and nausea/vomiting were observed in 7 patients (10.7%) group A and 7 patients (10.7%) in group C. None of the patients in group B developed complications. Conclusion The results of the present study showed that the use of 10 mg of melatonin before cesarean section with spinal anesthesia is not only safe, but also reduces the severity of patients' pain, increases the duration of postoperative analgesia, reduces the need for analgesics after surgery and resumption of physical activity.
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