Postoperative PainPhase 4NCT07892547
Intraperitoneal Hydrocortisone for Postoperative Pain and CRP Following Caesarean Section
A Phase 4 study testing hydrocortisone and Nornal Saline in people with Postoperative Pain and Caesarean Section, run by Raditsya Mada Gautama, MD at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Pain, Caesarean Section, Peritoneal Inflammation
- What is being tested?
- hydrocortisone and Nornal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Jun 2026to 11 Jul 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
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):
- Group H (Hydrocortisone Group): Received intraperitoneal instillation of 100 mg hydrocortisone diluted in 100 mL NaCl 0.9% solution administered evenly into the peritoneal cavity prior to parietal peritoneal closure.
- Group P (Placebo Group): Received intraperitoneal instillation of 100 mL NaCl 0.9% solution alone.
Primary Outcomes and Follow-up:
- Postoperative acute pain intensity assessed at rest and movement using the Visual Analog Scale (VAS, 0-10 cm) at 6, 12, and 24 hours postoperatively.
- Inflammatory stress response evaluated by measuring serum C-Reactive Protein (CRP) levels preoperatively and 24 hours postoperatively.
- Total 24-hour rescue analgesic consumption and incidence of corticosteroid-related adverse effects.
- Being tested
- hydrocortisone, Nornal Saline
- Keywords
- Intraperitoneal Hydrocortisone, Transversus Abdominis Plane Block, C-Reactive Protein, Multimodal Analgesia, Randomized Controlled Trial
- Medical subject headings
- Pain, Postoperative, Peritonitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
100 mg of hydrocortisone dissolved in 100 mL NaCl 0.9% administered intraperitoneally
Nornal SalineDrug
100 mL of NaCl 0.9% administered intraperitoneally as a placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| Hydrocortisone Group | Experimental | Received 100 mg hydrocortisone dissolved in 100 mL NaCl 0.9% administered intraperitoneall Receives: Drug: hydrocortisone |
| Placebo Group | Placebo comparator | Received 100 mL NaCl 0.9% administered intraperitoneally Receives: Drug: Nornal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Evaluated using the Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst pain imaginable) at rest and movement
Measured: At 6, 12, and 24 hours postoperatively
Secondary outcomes (2)
Serum C-Reactive Protein (CRP) Levels
Measured via immunoturbidimetry to evaluate systemic inflammatory response preoperatively, at 12 hours, and at 24 hours postoperatively
Measured: 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
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start25 Jun 2026
- Primary completion10 Jul 2026
- Study completion11 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raditsya Mada Gautama, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raditsya Mada Gautama, MD, Hasanuddin University
- Investigators
- Raditsya M Gautama, MD, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892547
- Sponsor's protocol ID
- 790/UN4.6.4.5.31/PP36/2026
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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