Transversus Abdominis Plane (TAP) Block and Erector Spinae Plane (ESP) Block Comparison on Postoperative Pain and the Need for Morphine in Gynecological Surgery Patients Who Underwent Median Incision in Hasan Sadikin General Hospital
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
- Postoperative Numerical Rating Scale
研究概览
简要总结
The goal of this double blind randomized controlled trial is to compare transversus abdominis plane block and erector spinae plane block in gynecological surgery patients. The main questions it aims to answer are:
- What are the numerical post-operative pain scores in these two groups?
- Is there any significant difference in the numerical post-operative pain scores between subjects who underwent TAP block and subjects who underwent ESP block?
- What are the differences in the time needed for additional morphine in these two groups?
- Is there any significant differences in the time needed for additional morphine between subjects who underwent TAP block and subjects who underwent ESP block?
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects with gynecological surgery techniques with a median incision include: hysterectomy, myomectomy, salpingectomy, ovarectomy and ovarian cystectomy.
- •Subjects with physical status based on the American Society of Anesthesiologists (ASA) in categories I-II
- •Subjects who are willing to sign informed consent form.
排除标准
- •The patient has a history of allergies to local anesthetic drugs used for TAP blockade or ESP blockade and is allergic to morphine.
- •Patients who have skin infections at the injection site.
- •Patients with a history of chronic pain, namely a history of pain for more than 1 month obtained from history taking.
- •Patients with a history of chronic pain treatment obtained from history taking.
- •Patients with impaired kidney function (Ureum >39 mg/dL; Creatinine >1.3 mg/dL) and liver (SGOT >37 U/L; SGPT >59 U/L), myopathy, coagulopathy obtained from the results of supporting examinations, heart rhythm disorders obtained from the results of an EKG examination and neurological disorders in the form of hypesthesia or paraesthesia obtained from the results of a physical examination in the form of a sensory examination.
- •The patient is pregnant as determined by history taking.
- •Patients who are illiterate as obtained from history taking.
- •The patient was uncooperative during examination.
研究组 & 干预措施
Transversus Abdominis Plane (TAP) Anesthestic Block
Ultrasound-guided TAP block is done using 20 mL of 0.25% Bupivacaine administered at the lateral abdominal wall between the costal margin and the iliac crest
干预措施: Transversus Abdominis Plane Block using 0.25% Bupivacaine (Procedure)
Erector Spinae Plane (ESP) Anesthetic Block
Ultrasound-guided ESP block is done using 20 mL of 0.25% Bupivacaine administered at the tip of the transverse process at the T9 level
干预措施: Erector Spinae Plane Block using 0.25% Bupivacaine (Procedure)
结局指标
主要结局
Postoperative Numerical Rating Scale
时间窗: 24 hours post operative
The degree of pain assessment is classified based on the Numeric Rating Scale pain assessment scale) with the lowest scale being no pain (value 0), up to the heaviest pain scale (value 10) when still, namely when the patient does not make any movement and moves, namely when mobilization is carried out on the left side and right tilt
次要结局
- Time of first need for analgesic rescue(24 hours post operative)
- Total postoperative morphine requirements(24 hours post operative)