BACKGROUND AND PURPOSE:

• Dafna et al. (AJOG MFM, 2019) compared three nonopioid analgesic regimens following cesarean delivery

METHODS:

• Open-label randomized controlled trial (RCT)
• Participants
  • ≥18 years undergoing elective cesarean delivery, without major complications
  • Term (≥37 weeks)
  • Regional anesthesia during surgery

Pain relief regimens

Fixed Interval Protocol

• Fixed IV protocol: 1 g IV paracetamol (acetaminophen) 3 times daily with 400 mg oral ibuprofen twice daily
• Fixed oral protocol: 1 g oral paracetamol 3 times daily with 400 mg oral ibuprofen twice daily
• For breakthrough pain
  • VAS score 4–5: 1 g oral drops dipyrone up to 4 times a day
  • VAS score >6 or persistent pain >1 hour after dipyrone: 100 mg tramadol hydrochloride up to 3 times a day

On-demand protocol

• VAS score 1–3: 1 g paracetamol up to 4 times a day
• VAS score 4–7 or persistent pain >1 hour after paracetamol: 1 g drops of dipyrone up to 4 times a day
• VAS score 8–10 or persistent pain that did not resolve >1 hour after dipyrone: 400-mg ibuprofen up to 3 times a day
• To measure pain intensity
  • Visual analog scale: 0 (no pain) to 10 (worst pain)
• Statistical analysis
  • Assumptions: (1) Fixed protocol groups would be 1 point lower than in the on-demand group and (2) average VAS score in the IV paracetamol protocol would be 1 point lower than in the oral paracetamol protocol
  • Power of 95% and an alpha error of 0.05: 120 women total needed to detect a 1-point difference in the 0-to-10 VAS score
• Primary outcome: Average pain intensity during the first 48 hours after surgery
• Secondary outcomes
  • Total doses of pain relief analgesia
  • Maternal and neonatal adverse effects

RESULTS:

• 127 women
  • IV group (n=41) | Oral protocol group (n=43) | On-demand protocol group (n=43)
  • Maternal and pregnancy characteristics were similar between groups as was surgical technique
• Average visual analog scale score
  • First 24 hours (P=.01)
    • IV group: 6.2±0.8
    • Oral protocol group: 7.0±1.1
    • On-demand protocol group: 7.5±0.7
  • At 48 hours (P<0.001)
    • IV group: 6.4±0.7
    • Oral protocol group: 6.8±0.9
    • On-demand protocol group: 7.4±0.7
• Average pain score reduction was higher in the IV protocol compared with the fixed oral protocol group (P=0.02)
  • IV protocol: 4.7±1.2
  • Fixed oral protocol group: 4.0±1.4
• Median doses of pain relief analgesia
  • First 24 hours (P=0.001)
    • Intravenous protocol group: 5 (interquartile range, 5–7)
    • Oral protocol group: 6 (interquartile range, 4–6)
    • On-demand protocol group: 4 (interquartile range, 3–6)
  • At 48 hours (P<0.001)
    • Intravenous protocol group: 9 (interquartile range, 7–10)
    • Oral protocol group: 9 (interquartile range, 7–10)
    • On-demand protocol group: 7 (interquartile range, 4–9)
• There were no “between group” differences for
  • Neonatal birthweight
  • Maternal and neonatal adverse outcomes

CONCLUSION:

• Pain scores were reduced in the fixed time interval analgesia (both oral and IV) group post cesarean vs on-demand regimen even though women in the on-demand group used fewer doses
• The data shows IV paracetamol to be superior to oral route, with superior pain scores already demonstrable in the first 24 hours
• The authors conclude

…for the first 24 hours after cesarean delivery, it would seem reasonable to treat patients with intravenous paracetamol combined with ibuprofen to yield the best pain control relief

Learn More – Primary Sources:

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

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