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NCT07718360

Overview

NCT ID: NCT07718360
Lead Sponsor: KRL Hospital, IslamabadOTHER
Official Title: Effect of Single-Dose Administration of Dexamethasone on Postoperative Pain in Patients Undergoing Cesarean Section Under Spinal Anesthesia
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.

Status and Timeline

Status: Completed
Last Update Posted: Jul 21, 2026Actual
Start Date: Mar 1, 2024Actual
Primary Completion Date: Sep 1, 2024Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Study Plan

Study Type: Interventional
Phase: Phase 4
Enrollment: 80Actual
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: No data available
Locations: KRL Hospital, Islamabad

Similar Studies

Participant Group/Arms

Dexamethasone GroupExperimental

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 GroupPlacebo 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