Ultrasound-guided Transversus Abdominis Plane Block and Quadratus Lumborum Block as Preventive Analgesia in Total Abdominal Hysterectomy With Pfannenstiel Incision: a Prospective, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- iv PCA tramadol consumption
研究概览
简要总结
Effective analgesia after total abdominal hysterectomy is important for faster recovery and preventing complications which depend to pain. A multimodal and preventive approach is preferred to ensure adequate analgesia and to avoid side effects due to high doses of analgesics. The hypothesis was that the Quadratus Lumborum block (application of local anesthetics to the side of the abdomen) would be superior to Transversus Abdominis Plane block (application of local anesthetics in front of the abdomen) for analgesia before abdominal incision in total abdominal hysterectomy. The primary goal of the study was to evaluate the feasibility of ultrasound-guided Transversus Abdominis Plane block and Quadratus Lumborum block. The secondary goal was to evaluate postoperative adverse effects and patient satisfaction.
详细描述
The study protocol was approved by the Local Ethics Committee. Written informed consent was obtained from each patient. The study was carried out in accordance with The Code of Ethics of the Declaration of Helsinki. The study was conducted between April 2017 - July 2017 with a prospective, randomized, double-blind design on 62 patients who had undergone total abdominal hysterectomy with Pfannenstiel incision. American Society of Anesthesiologist (ASA) II-III, patients between the ages of 18-75 were included in the study. The participants with bleeding diathesis, those who could not communicate (mental disorder, language problem, etc.), those with allergies to the drugs used, those who did not wish to participate in the study, and those who had an infection in the block area were excluded from the study. The participants were divided into 2 groups with the sealed envelope technique preoperatively Transversus Abdominis Plane Block Procedure Before the surgical procedure, the muscles were screened at the umbilicus plain/mid-axillary line with the ultrasound using a linear probe while the participants in the supine position. The skin, subcutaneous adipose tissue, external oblique muscle, internal oblique muscle, transversus abdominis muscle, and peritoneum were visualized. The block needle was advanced in the posterolateral direction with the in-plain approach. 0.3 ml/kg of 0.25% bupivacaine was administered bilaterally into the space between the internal oblique muscle and the transversus abdominis muscle.
Transmuscular Quadratus Lumborum Block Procedure Quadratus lumborum muscle could be recognized with ultrasound via the convex probe was transversally attached above iliac crest at the midaxillary line while the patients were in the lateral decubitus position. The point of injection with a block needle in transmuscular Quadratus Lumborum Block is between the anterior border of Quadratus lumborum muscle and psoas major muscles. A transmuscular Quadratus Lumborum Block was performed bilaterally with 0,3 ml/kg 0.25% bupivacaine solution injection on each side.
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
- Double (Participant, Outcomes Assessor)
盲法说明
After general anesthesia was given to the participant, the blocks were made. The participant did not know the type of block made to him.The outcomes assessor evaluating the participants after the surgery does not know the type of block made to the patients.
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
- •Undergone total abdominal hysterectomy with Pfannenstiel incision
- •American Society of Anesthesiologist (ASA) I-III
- •Patients between the ages of 18-65
排除标准
- •Patients with bleeding diathesis
- •Patients who could not communicate (mental disorder, language problem, etc.)
- •Patients with allergies to the drugs used
- •Patients who did not wish to participate in the study
- •Patients who had an infection in the block area
结局指标
主要结局
iv PCA tramadol consumption
时间窗: 24 hours
tramadol consumption up to 24 hours
intraoperatively fentanyl use
时间窗: during operation
Total intraoperative fentanyl dose
The Visual analogue Scale (VAS)
时间窗: 24 hours
The Visual Analogue Scale was used to measure the severity of postoperative pain (0= No pain, 10= The worst possible pain) up to 24 hours. Higher scores mean a worse outcome.
次要结局
- postoperative adverse effects(24 hours)
- patient and surgeon satisfaction: scores(24 hours)
研究者
Canan Yılmaz
principal investigator
Bursa Yuksek Ihtisas Training and Research Hospital
