Comparison of 3 protocols for analgesia control after cesarean delivery: a randomized controlled trial

Abstract

Proper pain control after cesarean delivery is of high clinical importance to the recovery and relief of patients after surgical delivery. We aimed to compare fixed time interval to on-demand regimens of nonopioid analgesics and to assess whether a protocol that is based on intravenous administration is superior to oral administration. This was a randomized controlled trial performed between April 2017 and May 2018. Patients who underwent elective cesarean delivery were assigned randomly to receive 1 of 3 pain relief protocols for the first 48 hours after surgery: (1) the fixed intravenous protocol included intravenous paracetamol (acetaminophen) 3 times daily with oral ibuprofen twice daily, (2) the fixed oral protocol included oral paracetamol 3 times daily with oral ibuprofen twice daily; if the patient requested additional analgesia, tramadol hydrochloride or dipyrone were given as rescue treatments, (3) the on-demand protocol included oral paracetamol or ibuprofen or dipyrone (based on visual analog scale). Pain intensity was measured and compared with the use of the visual analog scale (range, 0 ([no pain] to 10 [worst pain]). Total doses of pain relief analgesia and maternal and neonatal adverse effects were compared between the groups. The study included 127 women who were assigned randomly to the intravenous protocol group (n=41), oral protocol group (n=43), and on-demand protocol group (n=43). There were no between group differences in maternal and pregnancy characteristics, cesarean delivery indications, or surgical technique. The average visual analog scale score was 6.2±0.8 in the intravenous group, 7.0±1.1 in the oral group, and 7.5±0.7 in the on-demand group, in the first 24 hours (P=.01) and 6.4±0.7, 6.8±0.9, and 7.4±0.7 for the total 48 hours, respectively (P<.001). Mean pain score reduction was higher in the intravenous protocol compared with the fixed oral protocol group (4.7±1.2 vs 4.0±1.4; P=.02). The median doses of pain relief analgesia in the intravenous group were 5 (interquartile range, 5-7), 6 in the oral group (interquartile range, 4-6), and 4 in the on-demand group (interquartile range, 3-6; P=.001) in the first 24 hours and 9 (interquartile range, 7-10), 9 (interquartile range, 7-10), and 7 (interquartile range, 4-9), respectively, for the total 48 hours (P<.001). There were no "between group" differences in neonatal birthweight or maternal and neonatal adverse outcomes. Administration of pain relief analgesia (ibuprofen and acetaminophen) in fixed time intervals (intravenous or oral) after cesarean delivery yielded reduced visual analog scale pain scores compared with an on-demand protocol, despite fewer pain relief drugs consumed in the on-demand group.