NCT07502235

The Effect of Lactoferrin on Pain Management Following Cesarean Section

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Cesarean section is one of the most commonly performed surgical procedures worldwide, and optimal postoperative pain control remains a clinical priority. Inadequate pain management can delay recovery, impair maternal-infant interaction, prolong hospitalization, and increase the risk of complications such as thromboembolism. Although opioids are effective for postoperative analgesia, their use is limited by dose-dependent adverse effects, prompting the need for adjunctive therapies that enhance analgesia while reducing opioid requirements. Lactoferrin is a naturally occurring iron-binding glycoprotein present in breast milk and other body secretions, with well-documented anti-inflammatory, antioxidant, and immunomodulatory properties. Experimental and clinical evidence suggests that lactoferrin modulates key inflammatory mediators involved in pain signaling, including pro-inflammatory cytokines, and may exert antinociceptive effects through both peripheral and central mechanisms. These properties support its potential role as an adjunct in postoperative pain management; however, its efficacy in this setting has not been evaluated in a randomized clinical trial. This study is designed as a prospective, randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of lactoferrin on postoperative pain following elective cesarean section. Eligible participants will be randomized in a 1:1 ratio to receive either oral lactoferrin (250 mg twice daily) or a matching placebo. The first dose will be administered one hour prior to surgery, followed by continued dosing every 12 hours for 48 hours postoperatively. All participants will receive standardized spinal anesthesia and routine perioperative and postoperative analgesic care. The primary objective is to assess the effect of lactoferrin on postoperative pain intensity, measured using a visual analog scale at predefined time points within the first 24 hours after surgery. Secondary objectives include evaluation of opioid consumption, time to first request for rescue analgesia, incidence of postoperative nausea and vomiting, other postoperative symptoms, time to mobilization, functional recovery, patient satisfaction, and hospital length of stay. Safety will be assessed through monitoring of adverse events, including gastrointestinal symptoms, allergic reactions, and other treatment-related effects. All adverse events will be documented and evaluated for severity and causality. The sample size has been calculated to provide adequate statistical power to detect clinically meaningful differences in primary and secondary outcomes between groups. Statistical analyses will be conducted using an intention-to-treat approach with appropriate methods for continuous and categorical variables. This trial aims to provide clinical evidence on the potential role of lactoferrin as a safe and effective adjunct to standard analgesic regimens for improving postoperative pain control and recovery following cesarean section.

Conditions

• Cesarean Birth
• Post Operative Analgesia

Interventions

Type	Name	Description
DRUG	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
OTHER	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).

Timeline

• Start date: 2026-03-26
• Primary completion: 2026-08-26
• Completion: 2026-09-26
• First posted: 2026-03-30
• Last updated: 2026-03-30

Locations

1 site across 1 country: Egypt