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

NCT07718360 | Completed Phase 4

• 1 other identifier: 23011995
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Spinal Anesthesia; Cesarean Section Pain

Keywords

Dexamethasone; Postoperative analgesia; Lower segment cesarean section; Spinal anesthesia; Rescue analgesia; Corticosteroid; Cesarean Section

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  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.

  2, 6, 12, and 24 hours postoperatively

Secondary Outcomes (2)

• Time to First Rescue Analgesia

  Within 24 hours postoperatively

• Proportion of Patients Requiring Rescue Analgesia

  Within 24 hours postoperatively

Study Arms (2)

Dexamethasone Group

EXPERIMENTAL

Participants received a single intravenous dose of dexamethasone 8 mg (2 ml) prior to spinal anesthesia for elective lower segment cesarean section. Standard spinal anesthesia was administered to all participants. Postoperative pain was assessed using VAS at 2, 6, 12, and 24 hours.

Drug: Dexamethasone (IV)

Placebo Group

PLACEBO COMPARATOR

Participants received a single intravenous dose of normal saline 0.9% (2 ml) prior to spinal anesthesia for elective lower segment cesarean section. Standard spinal anesthesia was administered to all participants. Postoperative pain was assessed using VAS at 2, 6, 12, and 24 hours.

Drug: Normal Saline 0.9% Infusion Solution

Interventions

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).

Also known as: Decadron, Dexamethasone Sodium Phosphate

Dexamethasone Group

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).

Also known as: Sodium Chloride 0.9%

Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KRL Hospital, Islamabad: lead

Study Sites (1)

KRL Hospital, Islamabad

Islamabad, Federal Capital Territory, 44000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone; Calcium Dobesilate; dexamethasone 21-phosphate; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 21, 2026
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)