A Comparative Study Between Ultrasound-guided Serratus Anterior Plane Block and Conventional IV Analgesics in Postoperative Pain Management in Modified Radical Mastectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- the time of first rescue analgesic
研究概览
简要总结
The aim of this study is to compare the effect of ultra-sound guided serratus anterior plane block versus conventional IV analgesics in postoperative pain management in modified radical mastectomy (MRM)
详细描述
All patients undergoing modified radical mastectomy were assigned to one of the following two groups:Group A: Serratus anterior plane block group (SAPB group): this group consists of 20 patients who received ultra sound guided serratus anterior plane block just after induction of anesthesia and Group B: IV analgesics group (control group): this group consists of 20 patients who did not receive any type of block.Further evaluations were carried out by a different investigator who was unaware of the patients' grouping. The degree of post-operative pain was assessed at: just upon arrival to the PACU, 2, 4, 8, 12 and 24 hours using the VAS score and the haemodynamic data and respiratory rate were measured during the first 24 hours after the end of the surgery. Postoperative analgesia regimen was standard in both groups; patients from each groups received 1 gm of Paracetamol Q 8 hours.
Patients reporting VAS ( visual analogue score) score greater than 40, mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline, were given Pethidine (50 mg IV) as rescue analgesic. While, those reporting VAS score less than 40 with mean arterial blood pressure, heart rate or respiratory rate >20% from the baseline but still complaining; Ketoralac (30 mg IV) was given with a maximum dose of 120 mg/ day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
盲法说明
double blind
入排标准
- 年龄范围
- 20 Years 至 60 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females aged between 20-60 years old.
- •Preoperative physical status: ASA (American Society of Anesthesiology) I & II.
- •Body mass index (BMI) < 35 Kg/ m
- •Candidate for unilateral modified radical mastectomy.
- •Informed consent to participate in the study.
排除标准
- •- Females aged < 20 years old or > 60 years old.
- •Preoperative physical status: ASA III & IV.
- •Morbid obese patients with BMI > 35 Kg/ m
- •Refusal to participate in the study.
- •Addiction to narcotics or psycho-active drugs.
- •Psychological disorders.
- •Contra-indications to regional anesthesia (coagulopathy, injection site infection or allergy to any of the study drugs)
结局指标
主要结局
the time of first rescue analgesic
时间窗: it is measured for 24 hours after the end of surgery.
the time taken by the patient to receive first dose of rescue analgesia, guided by the patients VAS score ( if the patients VAS score is 4 or more, the patient receives 50 mg of Pethidine).
total dose of rescue analgesics
时间窗: it is measured for 24 hours after the end of surgery.
the total dose of Pethidine needed by each patient measured in mg.
次要结局
- incidence of nausea and vomiting(24 hours after the end of surgery.)
- patients satisfaction(24 hours after the end of surgery.)
- incidence of any block related complications.(24 hours after the end of surgery.)
