Effect of Single-Dose Administration of Dexamethasone on Postoperative Pain in Patients Undergoing Cesarean Section Under Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Postoperative Pain Intensity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Postoperative Pain Intensity
时间窗: 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.
次要结局
- Time to First Rescue Analgesia(Within 24 hours postoperatively)
- Proportion of Patients Requiring Rescue Analgesia(Within 24 hours postoperatively)
研究者
Komal Shahid
Principal Investigator
KRL Hospital, Islamabad