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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07718360
Enrollment
80
Registered
2026-07-21
Start date
2024-03-01
Completion date
2024-09-01
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Anesthesia, Cesarean Section Pain, Postoperative Pain

Keywords

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

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.

Detailed description

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.

Interventions

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

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).

Sponsors

KRL Hospital, Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

1. Female patients aged 18-40 years 2. Scheduled for elective lower segment cesarean section (LSCS) 3. Spinal anesthesia planned and suitable 4. ASA physical status Class I or II 5. Gestational age ≥ 37 weeks 6. Willing to participate and able to provide written informed consent

Exclusion criteria

1. Known allergy or hypersensitivity to dexamethasone or any corticosteroid 2. Diabetes mellitus or uncontrolled hyperglycemia 3. Current or recent (within 4 weeks) corticosteroid use 4. Contraindication to spinal anesthesia (coagulopathy, infection at puncture site, patient refusal) 5. Emergency cesarean section 6. Systemic infection or sepsis 7. Significant hepatic, renal, or cardiovascular disease 8. Peptic ulcer disease 9. Psychiatric illness 10. Failure of spinal anesthesia requiring conversion to general anesthesia 11. BMI \> 35 kg/m²

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Pain Intensity2, 6, 12, and 24 hours postoperativelyPain 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

MeasureTime frameDescription
Time to First Rescue AnalgesiaWithin 24 hours postoperativelyTime elapsed (in hours) from end of surgery to first administration of rescue analgesia, given when VAS score exceeded 4.
Proportion of Patients Requiring Rescue AnalgesiaWithin 24 hours postoperativelyNumber of participants in each group who required at least one dose of rescue analgesia within 24 hours of surgery.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026