RANDOMIZED CONTROLLED SINGLE-BLIND TRIAL TO COMPARE THE EFFICACY AND SAFETY OF DICLOFENAC SODIUM VERSUS TRAMADOL FOR POST-LSCS ANALGESIA IN PATIENTS WITH PREECLAMPSIA

Abstract

: Effective postoperative analgesia following lower segment caesarean section (LSCS) is crucial for maternal recovery, especially in preeclamptic (PE) patients who have unique pathophysiological challenges. In this background, this randomized controlled single-blind trial aimed is to compare the efficacy and safety of diclofenac sodium versus tramadol for post-LSCS analgesia in patients with preeclampsia.

METHODS: A total of 200 post-LSCS patients with preeclampsia were randomly assigned to two groups. Group A (n=100) received intramuscular diclofenac sodium (75 mg every 8 hours for 2 days), followed by oral diclofenac (100 mg TDS for 5 days). Group B (n=100) received intramuscular tramadol (100 mg every 8 hours for 2 days), followed by oral tramadol (100 mg TDS for 5 days). Pain relief was assessed using the Visual Analogue Scale (VAS) and Verbal Response Scale (VRS), while clinical parameters, including blood pressure, weight changes, and renal and hepatic functions, were monitored preoperatively and postoperatively at 48 hours, 5 days, and 7 days. Statistical analysis was performed using SPSS version 2.0.

RESULTS: The demographic characteristics of both groups were comparable. Tramadol was more effective in pain control, with a significantly higher proportion of patients reporting mild pain on the 7th postoperative day (96% vs. 85%, p=0.09). Diclofenac sodium showed higher incidences of mild to moderate pain on the 2nd postoperative day compared to tramadol (p<0.0001). Weight reduction and blood pressure control were significantly better in the tramadol group, with notable reductions in systolic (p=0.002) and diastolic blood pressure (p=0.0001). No major adverse effects or complications were reported in either groups.

CONCLUSION: Tramadol provided superior postoperative pain relief and better hemodynamic stability, hematologic & biochemical parameters in preeclamptic patients compared to diclofenac sodium, making it a preferable choice for post-LSCS analgesia in this high-risk group.