Intraperitoneal Hydrocortisone for Postoperative Pain and CRP Following Caesarean Section

NCT07892547 | Completed Phase 4

• 1 other identifier: 790/UN4.6.4.5.31/PP36/2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Caesarean Section; Peritoneal Inflammation

Keywords

Intraperitoneal Hydrocortisone; Transversus Abdominis Plane Block; C-Reactive Protein; Multimodal Analgesia; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable) at rest and movement

  At 6, 12, and 24 hours postoperatively

Secondary Outcomes (2)

• Serum C-Reactive Protein (CRP) Levels

  Preoperative baseline, 12 hours, and 24 hours postoperatively

• Rescue Analgesia Requirements and Adverse Events

  Within 24 hours postoperatively

Study Arms (2)

Hydrocortisone Group

EXPERIMENTAL

Received 100 mg hydrocortisone dissolved in 100 mL NaCl 0.9% administered intraperitoneall

Drug: hydrocortisone

Placebo Group

PLACEBO COMPARATOR

Received 100 mL NaCl 0.9% administered intraperitoneally

Drug: Nornal Saline

Interventions

hydrocortisone DRUG

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

Hydrocortisone Group

Nornal Saline DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female aged 18-40 years old.
• Scheduled for elective Caesarean section under spinal anaesthesia.
• American Society of Anesthesiologists (ASA) physical status I-II.
• Willing to participate and signed the written informed consent.

You may not qualify if:

• History of hypersensitivity or allergy to corticosteroids.
• Regular corticosteroid therapy within the past 30 days.
• Diagnosis of pre-gestational or gestational diabetes mellitus requiring pharmacological treatment.
• History of coagulation disorders or anticoagulant use.
• Presence of active infection (sepsis, intra-abdominal infection) at recruitment.
• Major intraoperative complications (massive hemorrhage, conversion to general anesthesia, organ injury).
• Inability to communicate verbally for Visual Analog Scale (VAS) assessment (severe cognitive impairment).
• Withdrawal of consent after randomization.

Sponsors & Collaborators

• Raditsya Mada Gautama, MD: lead

Study Sites (1)

Dr. Soedirman General Hospital

Kebumen, Central Java, 54312, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative; Peritonitis

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Intraabdominal Infections; Infections; Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Study Officials

• Raditsya M Gautama, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind study. Both the study participants, care providers, investigators, and outcome assessors were blinded to the treatment allocation. The intervention solutions (hydrocortisone or normal saline placebo) were prepared in identical syringes by an independent pharmacist who was not involved in patient care or outcome assessment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator / Resident

Model Details: A parallel-group, double-blind, placebo-controlled randomized trial where participants were allocated in a 1:1 ratio to either the intraperitoneal hydrocortisone group or the placebo (normal saline) group

Study Record Dates

• First Submitted: October 18, 2026
• First Posted: October 23, 2026
• Study Start: June 25, 2026
• Primary Completion: July 10, 2026
• Study Completion: July 11, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)