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COMPLETED
NCT07892547
PHASE4

Intraperitoneal Hydrocortisone for Postoperative Pain and CRP Following Caesarean Section

Sponsor: Raditsya Mada Gautama, MD

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the clinical efficacy of intraperitoneal hydrocortisone 100 mg administration in reducing postoperative pain and inflammatory response in patients undergoing elective Caesarean section under spinal anaesthesia combined with bilateral Transversus Abdominis Plane (TAP) block. Postoperative pain following Caesarean section stems from both visceral and somatic surgical trauma. While TAP block effectively attenuates somatic wound pain, visceral pain mediated by peritoneal irritation remains a significant component of acute postoperative discomfort. Intraperitoneal instillation of local corticosteroids like hydrocortisone may modulate local inflammatory cascades, thereby reducing peritoneal nociceptor sensitization. This double-blind randomized controlled trial involved 50 term pregnant women scheduled for elective Caesarean section under spinal anaesthesia with bilateral TAP block. Participants were randomly assigned to receive either 100 mg hydrocortisone in 100 mL NaCl 0.9% or 100 mL NaCl 0.9% placebo instilled into the peritoneal cavity prior to abdominal closure. Postoperative pain intensity (measured via Visual Analog Scale \[VAS\] at 6, 12, and 24 hours) and serum C-Reactive Protein (CRP) levels at 24 hours postoperatively were compared between the two groups.

Official title: Efficacy of Intraperitoneal Hydrocortisone 100 mg in Reducing Postoperative Pain and C-Reactive Protein Following Elective Caesarean Section Under Spinal Anaesthesia With Bilateral TAP Block: A Double-Blind Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-06-25

Completion Date

2026-07-11

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DRUG

hydrocortisone

100 mg of hydrocortisone dissolved in 100 mL NaCl 0.9% administered intraperitoneally

DRUG

Nornal Saline

100 mL of NaCl 0.9% administered intraperitoneally as a placebo comparator.

Locations (1)

Dr. Soedirman General Hospital

Kebumen, Central Java, Indonesia