Intravenous Dexamethasone: Postoperative Analgesic Effect in Caesarean Section Under Spinal Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- tramadol requirements
研究概览
简要总结
The management of postpartum pain is essential to ensure early rehabilitation for parturients. Intravenous dexamethasone has a potent analgesic action when used in the context of general anesthesia. Nevertheless, it remains poorly studied in combination with spinal anesthesia (SA). The aim of this study was to assess the analgesic effect of intravenous dexamethasone after caesarean section under SA.
Methods: We conducted a prospective, randomized, double-blinded study including 84 ASA II-III parturient at term who were proposed for caesarean section under SA. Parturient were randomized into two groups: Dexamethasone group (DG) who received 8mg of intravenous dexamethasone (2ml) immediately after SA and placebo group (PG) who received 2ml of isotonic saline. The analgesic protocol was standardized and we opted for Tramadol as rescue analgesic. The main outcome is the use of Tramadol in the first 24 hours postpartum..
详细描述
A a prospective randomized double-blinded controlled study including 84 parturient women, conducted at the Anesthesia and Surgical Intensive Care Department of Mongi Slim University Hospital, La Marsa Tunisia. It was performed after obtaining the approval of the Research Ethical Committee of our hospital (Ethical Committee No. 02/2020). Eligible patients were informed of the study design and their written consent was obtained.
Patients:
Inclusion criteria were Age >= 18 years, American Society of Anesthesiologists (ASA) statue II-III, a pregnancy term >= 37 weeks, elective cesarean section and Pfannenstiel incision.
Exclusion criteria were severe hypertension / preeclampsia, poorly balanced diabetes mellitus, allergy to one of the study drugs, patients with chronic pain or long-term use of opioids, and patients on long-term corticosteroid therapy.
Study protocol During the preoperative visit, all patients have had a full clinical examination and further examinations have been requested in accordance with the most recent guidelines. The informed written consent was obtained at this moment. Postoperative pain predisposition (the prediction of pain and the anxiety level) was assessed using a questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) statue II-III,
- •a pregnancy term >= 37 weeks
- •elective cesarean section
- •Pfannenstiel incision
排除标准
- •severe hypertension / preeclampsia
- •poorly balanced diabetes mellitus
- •allergy to one of the study drugs
- •patients with chronic pain or long-term use of opioids
- •patients on long-term corticosteroid therapy.
研究组 & 干预措施
dexamethasone group
patients received 8mg(2ml) of intravenous dexamethasone after spinal anesthesia
干预措施: Dexamethasone 4mg (Drug)
placebo group
patients received 2ml of a saline solution after spinal anesthesia
干预措施: Placebo (Drug)
结局指标
主要结局
tramadol requirements
时间窗: 24 hours
The rescue analgesic was IV Tramadol 100 mg administered at the request of the patient and if the analog visual scale (AVS) was greater than 3/10, with a maximum dose of 100 mg \* 3/day.
次要结局
- pain scores(H2, H6, H12 and H24)
- postoperative nausea and vomiting(PONV)(24 hours)
- Chronic pain(3 months)
研究者
Mhamed Sami Mebazaa
clinical Professor
Mongi Slim Hospital