The Effect of Lactoferrin on Pain Management Following Cesarean Section
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorAin Shams University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Referred to elective (non-emergency) cesarean section
Undergoing spinal anesthesia) with American Society of Anesthesiologists (ASA) classification I and II
Term gestational age
Disqualifiers
History of seizures
Pre-eclampsia or eclampsia
Hypertension
Use of narcotic painkillers for 24 h before the intervention
Trial design
Design model
Parallel
Treatments tested in this trial
Lactoferrin
DrugLactoferrin 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
Other interventionmatching placebo capsules administered on the same schedule as the lactoferrin group (first dose 1 hour preoperatively, then every 12 hours for 48 hours).
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: LactoferrinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Pain intensity ( 2 hours)
Pain intensity using 10 cm Visual analogue scale (VAS)
Time frame
2 hours2
Pain intensity (6 hours)
pain intensity using 10 cm visual analogue scale (VAS)
Time frame
6 hours3
Pain intensity (12 hours)
pain intensity using 10 cm visual analogue scale (VAS)
Time frame
12 hours4
Pain intensity (24 hours)
pain intensity using 10 cm visual analogue scale (VAS)
Time frame
24 hoursSecondary outcomes
1
nausea and vomiting ( 2 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Time frame
2 hours2
nausea and vomiting (6 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Time frame
6 hours3
nausea and vomiting (12 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Time frame
12 hours4
nausea and vomiting (24 hours)
severity of nausea/ vomiting (n/v) using a numerical scale from 0 to 2 (0=no nausea, 1= mild n/v, and 2= severe n/v)
Time frame
24 hoursSponsors and contacts
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Source ClinicalTrials.gov
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