A Phase 4 interventional study of hydrocortisone and Nornal Saline in Postoperative Pain, Caesarean Section and Peritoneal Inflammation, sponsored by Raditsya Mada Gautama, MD. Completed at 1 site in Indonesia. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Raditsya Mada Gautama, MD · Phase 4, Interventional, and Treatment
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.
Background and Rationale:
Effective postoperative analgesia following Caesarean delivery is paramount for early maternal mobilization, successful breastfeeding initiation, and maternal-infant bonding. Multimodal analgesic strategies, combining systemic analgesics and regional nerve blocks like bilateral Transversus Abdominis Plane (TAP) blocks, are widely utilized. However, TAP block selectively targets somatic pain of the anterior abdominal wall (T10-L1 dermatomes) and does not alleviate visceral pain resulting from uterine contraction and peritoneal manipulation.
Intraperitoneal administration of corticosteroids has been proposed as an adjunctive therapy to suppress local peritoneal inflammation, decrease pro-inflammatory cytokine release, and reduce visceral nociceptive signaling. Hydrocortisone possesses rapid anti-inflammatory properties that may complement multimodal analgesia.
Study Methodology and Intervention:
In this prospective, double-blind, randomized controlled trial, 50 eligible patients undergoing elective Caesarean section under standardized spinal anaesthesia (hyperbaric bupivacaine 0.5% + morfin) and bilateral ultrasound-guided TAP block were enrolled.
Patients were randomized into two equal groups (n = 25 per group):
Primary Outcomes and Follow-up:
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 50 is below the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Received 100 mg hydrocortisone dissolved in 100 mL NaCl 0.9% administered intraperitoneall
Drug: hydrocortisone
Received 100 mL NaCl 0.9% administered intraperitoneally
Drug: Nornal Saline
100 mg of hydrocortisone dissolved in 100 mL NaCl 0.9% administered intraperitoneally
100 mL of NaCl 0.9% administered intraperitoneally as a placebo comparator.
Postoperative Pain Intensity
Evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable) at rest and movement
Time frame: At 6, 12, and 24 hours postoperatively
Serum C-Reactive Protein (CRP) Levels
Measured via immunoturbidimetry to evaluate systemic inflammatory response preoperatively, at 12 hours, and at 24 hours postoperatively
Time frame: Preoperative baseline, 12 hours, and 24 hours postoperatively
Rescue Analgesia Requirements and Adverse Events
Frequency and time of first rescue analgesia (IV fentanyl) required due to VAS ≥ 5, alongside monitoring for intervention-related adverse events such as nausea/vomiting, pruritus, and blood glucose levels
Time frame: Within 24 hours postoperatively
Plan to share: No — The datasets generated and/or analyzed during the current study are not publicly available due to institutional privacy policies regarding patient medical records, but are available from the corresponding author on reasonable request
No publications or documents are linked to this record.
Ran from Jun 2026 to primary completion in Jul 2026, 0 months.
Of 492 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 0 months is below that.
Counting every sponsor, half of 497 studies reached it within 15 months; a quarter within 8 and three quarters within 31.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydrocortisone