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NCT Number: NCT07718360

Effect of Single-Dose Dexamethasone on Postoperative Pain After Cesarean Section Under Spinal Anesthesia

This study looked at whether giving a single dose of dexamethasone (a steroid medicine, 8 mg given into the vein) before a cesarean section could reduce pain after the operation.

Eighty women having a planned cesarean section under spinal anesthesia at KRL Hospital, Islamabad were divided into two equal groups by chance. One group received dexamethasone through a drip before the procedure; the other group received a harmless salt-water solution (normal saline) as a comparison.

Pain levels were measured using a 0-10 pain scale at 2, 6, 12, and 24 hours after surgery. The study also recorded how long it took before patients needed an extra painkiller.

The group that received dexamethasone reported significantly less pain at 6, 12, and 24 hours after surgery, and far fewer patients in that group needed additional pain relief (7.5% vs 65%). The drug was well tolerated with no major side effects.

The findings suggest that a single pre-operative dose of dexamethasone is a simple and effective way to improve pain control after cesarean section.

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Key information

Conditions

Spinal Anesthesia Cesarean Section Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

KRL Hospital, Islamabad

Islamabad, Federal Capital Territory, 44000, Pakistan

About this study

Postoperative pain following lower segment cesarean section (LSCS) remains a significant clinical concern, particularly as spinal anesthesia wears off within the first few post-operative hours. Dexamethasone, a corticosteroid with known anti-inflammatory and analgesic properties, has been studied as an adjunct for postoperative pain control in various surgical settings.

This randomized controlled trial enrolled 80 ASA I-II patients aged 18-40 years undergoing elective LSCS under spinal anesthesia. Patients were randomized into two groups (n=40 each) using non-probability consecutive sampling. Group A received intravenous dexamethasone 8 mg (2 ml) prior to induction; Group B received intravenous normal saline 0.9% (2 ml) as placebo. Standard spinal anesthesia was administered to all participants.

Pain intensity was assessed using the Visual Analogue Scale (VAS, 0-10) at 2, 6, 12, and 24 hours postoperatively. Rescue analgesia was administered when VAS exceeded 4. Time to first rescue analgesia was recorded as a secondary outcome.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients aged 18-40 years
  • Scheduled for elective lower segment cesarean section (LSCS)
  • Spinal anesthesia planned and suitable
  • ASA physical status Class I or II
  • Gestational age ≥ 37 weeks
  • Willing to participate and able to provide written informed consent

Exclusion criteria

  • Known allergy or hypersensitivity to dexamethasone or any corticosteroid
  • Diabetes mellitus or uncontrolled hyperglycemia
  • Current or recent (within 4 weeks) corticosteroid use
  • Contraindication to spinal anesthesia (coagulopathy, infection at puncture site, patient refusal)
  • Emergency cesarean section
  • Systemic infection or sepsis
  • Significant hepatic, renal, or cardiovascular disease
  • Peptic ulcer disease
  • Psychiatric illness
  • Failure of spinal anesthesia requiring conversion to general anesthesia
  • BMI > 35 kg/m²

Treatment and study plan

Dexamethasone (IV)

Drug

Single intravenous dose of dexamethasone 8 mg (2 ml) administered prior to induction of spinal anesthesia. Applied to: Dexamethasone Group (Arm 1).

Other names: Decadron, Dexamethasone Sodium Phosphate

Normal Saline 0.9% Infusion Solution

Drug

Single intravenous dose of normal saline 0.9% (2 ml) administered prior to induction of spinal anesthesia, serving as placebo control. Applied to: Placebo Group (Arm 2).

Other names: Sodium Chloride 0.9%

Primary outcomes

  1. Postoperative Pain Intensity

    Time frame: 2, 6, 12, and 24 hours postoperatively

    Pain intensity measured using the Visual Analogue Scale (VAS, 0-10; 0 = no pain, 10 = worst pain) at 2, 6, 12, and 24 hours after surgery.

Secondary outcomes

  1. Time to First Rescue Analgesia

    Time frame: Within 24 hours postoperatively

    Time elapsed (in hours) from end of surgery to first administration of rescue analgesia, given when VAS score exceeded 4.

  2. Proportion of Patients Requiring Rescue Analgesia

    Time frame: Within 24 hours postoperatively

    Number of participants in each group who required at least one dose of rescue analgesia within 24 hours of surgery.

Sponsors and collaborators

Lead sponsor

KRL Hospital, Islamabad

Other

Registry information

Official study title

Effect of Single-Dose Administration of Dexamethasone on Postoperative Pain in Patients Undergoing Cesarean Section Under Spinal Anesthesia

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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