The Effect of Lactoferrin on Pain Management Following Cesarean Section

NCT07502235 | Not Yet Recruiting Phase 3

• 1 other identifier: REC-FPFUE_NO 6/2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Birth; Post Operative Analgesia

Keywords

post operative pain; lactoferrin; analgesia; pain management; obstetric surgery; post operative analgesia

Outcome Measures

Primary Outcomes (4)

• Pain intensity ( 2 hours)

  Pain intensity using 10 cm Visual analogue scale (VAS)

  2 hours

• Pain intensity (6 hours)

  pain intensity using 10 cm visual analogue scale (VAS)

  6 hours

• Pain intensity (12 hours)

  pain intensity using 10 cm visual analogue scale (VAS)

  12 hours

• Pain intensity (24 hours)

  pain intensity using 10 cm visual analogue scale (VAS)

  24 hours

Secondary Outcomes (6)

• nausea and vomiting ( 2 hours)

  2 hours

• nausea and vomiting (6 hours)

  6 hours

• nausea and vomiting (12 hours)

  12 hours

• nausea and vomiting (24 hours)

  24 hours

• Rescue analgesia

  24 hours

Study Arms (2)

Lactoferrin

EXPERIMENTAL

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

Drug: Lactoferrin

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Placebo OTHER

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

Placebo

Lactoferrin DRUG

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

Lactoferrin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Referred to elective (non-emergency) cesarean section
• Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
• Term gestational age

You may not qualify if:

• History of seizures
• Pre-eclampsia or eclampsia
• Hypertension
• Use of narcotic painkillers for 24 h before the intervention
• Medications inducing neuropathy including Amiodarone, Metronidazole, Phenytoin \& Colchicine.
• Prolongation of cesarean section (more than 1.5 h)
• Increase in the size of the incision
• Occurrence of any unusual complication during surgery,
• Failure of spinal anesthesia and its conversion to general anesthesia
• Contraindications to spinal anesthesia
• Use of interacting medication: fluoroquinolones, loratadine, fexofenadine, alvimopan, armodafinil

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Mansoura Hospital

Cairo, 11856, Egypt

Location

Related Publications (1)

• Mohamed Elmokadem E, Khaled Abou El Fadl D, Bassiouny AM, Mahmoud MMAE, Samy M, El Said NO. The Adjunctive Effect of Quercetin on Postoperative Pain Management Following Cesarean Section: A Randomized Controlled Study. Drug Des Devel Ther. 2025 Jul 14;19:6009-6024. doi: 10.2147/DDDT.S526188. eCollection 2025.

  PMID: 40687903 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pharmacy Practice and Clinical Pharmacy

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: March 30, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): August 26, 2026
• Study Completion (Estimated): September 26, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)