The Effect of Lactoferrin on Pain Management Following Cesarean Section

Condition(s) studied

Investigational drug(s) / intervention(s)

Lactoferrin: Lactoferrin 250 mg orally twice daily (BID). The first dose will be given 1 hour preoperatively, followed by repeat doses every 12 hours for 48 hours postoperatively

Placebo: matching placebo capsules administered on the same schedule as the lactoferrin group (first dose 1 hour preoperatively, then every 12 hours for 48 hours).

Study summary

This study evaluates whether lactoferrin, a naturally occurring protein with anti-inflammatory and antioxidant properties, can improve pain control after cesarean section. Effective management of postoperative pain is essential to support maternal recovery, mobility, and the ability to care for the newborn, while minimizing reliance on opioid medications and their associated side effects.

In this randomized, double-blind, placebo-controlled trial, women undergoing elective cesarean section will receive either oral lactoferrin or a matching placebo in addition to standard postoperative analgesia. Lactoferrin will be administered starting before surgery and continued for 48 hours after delivery.

The study will assess whether lactoferrin reduces postoperative pain intensity and opioid consumption, and improves recovery outcomes such as time to mobilization, patient satisfaction, and incidence of common postoperative symptoms. Safety and tolerability will also be evaluated.

Eligibility

Primary outcome measure(s)

• Pain intensity ( 2 hours) — 2 hours
  Pain intensity using 10 cm Visual analogue scale (VAS)
• Pain intensity (6 hours) — 6 hours
  pain intensity using 10 cm visual analogue scale (VAS)
• Pain intensity (12 hours) — 12 hours
  pain intensity using 10 cm visual analogue scale (VAS)
• Pain intensity (24 hours) — 24 hours
  pain intensity using 10 cm visual analogue scale (VAS)

Trial sites (1)

More Ain Shams University trials in Egypt

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