Quadratus Lumborum Block Versus Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks for Postoperative Analgesia Following Total Abdominal Hysterectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The total dose of morphine used
研究概览
简要总结
Multimodal pain management program is needed to control severe pain after abdominal hysterectomy which is considered as one of the major abdominal surgeries. Opioids (which are the analgesic of choice) have many adverse effects such as sedation, nausea, and vomiting. Hence, different methods are needed to control pain and decrease opioid consumption and its side effects.
Transversus abdominis plane (TAP) block blocks the sensory afferent nerves run between the abdominal muscles and controls postoperative incisional pain.
Blanco was the first who described the quadratus lumborum block (QLB). Somatic pain after upper and lower abdominal surgery can be controlled by QLB. QLB can be performed for all generations (adult, pediatrics, and pregnant).
QLB is considered to be an easy technique to learn as it is easy to get the key sonoanatomic markers for QLB. The novice can learn this block after only a few performance of the procedure. QLB produces effective postoperative analgesia after abdominal surgery, laparoscopic surgery, anterior abdominal wall surgery, and hip and femur surgery. The analgesic effect of QLB covers 24-48 h. While some authors inserted catheter for continuous infusion of the local anesthetic drug to extend the duration of postoperative analgesia, others added dexamethasone to local anesthetic to extend the effect of local anesthetic drugs.
Ultrasound (US)-guided Ilioinguinal and Iliohypogastric nerve and TAP block have been established as analgesic adjuncts for post hernia repair pain management, under general anaesthesia, neuraxial, MAC and infiltration techniques.
US-guided technique of blocking Ilioinguinal and Iliohypogastric nerves have higher success rate compared to conventional technique. TAP block provides analgesia to the parietal peritoneum and skin of the abdomen in infra-umbilical surgeries. Few cadaveric studies showed good analgesic effect in the region between T10 and L1 following a single posterior TAP injection.
详细描述
All patients will be assessed preoperatively by history taking, physical examination, and laboratory evaluation. On arrival of the patients to the operative room, electrocardiography, non-invasive blood pressure, pulse oximetry, and capnography will be applied. Baseline parameters such as systolic blood pressure, diastolic blood pressure, mean blood pressure, heart rate (HR), and arterial oxygen saturation will be also recorded.
Intravenous (IV) line will be inserted and IV fluid will be started. For both groups, general anesthesia will be induced with IV injection of fentanyl (1 µg/kg) (Sunny Pharmaceutical, Egypt) and propofol (2mg/kg) (AstraZeneca, UK), and then, atracurium (0.5 mg/kg) (GlaxoSmithKline, UK) will be injected for endotracheal intubation.
Mechanical ventilation will be maintained to keep the end-expiratory CO2 values between 34 and 36 mmHg. Anesthesia will be continued with isoflurane 1%-2% in 100% O2. Incremental dose of atracurium (0.1 mg/kg) will be given every 30 min or when needed.
After endotracheal intubation and before the start of the surgery. A computer system will be used for randomization by creating a list of number each number referred to one of the two groups. Block randomization will be used to ensure equality of the groups. Each number will be sealed in an opaque envelope. Then, each patient will be asked to choose one of the envelopes and give to an anesthesiologist who compared it to the computer-generated list and hence assigned her to one of the two groups. Anesthesiologist (who will be blinded to the collected data until the end of the study) will perform the block techniques and administered the medication.
60 Patients were randomly allocated into two equal groups (each 30 patients):
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
- Single (Care Provider)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.60 female patients
- •aged 45-60 years
- •ASA Physical Status Class I and II
- •scheduled for abdominal hysterectomy
排除标准
- •Patients had infection at injection site
- •Allergy to local anesthetics
- •Coagulation disorders
- •Severe obesity
- •Physical or mental diseases which could interfere with the evaluation of pain scores
- •Kidney failure or liver failure.
结局指标
主要结局
The total dose of morphine used
时间窗: up to 24 hours postoperative
The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative
次要结局
- Duration of postoperative analgesia(up to 24 hours postoperative)
- The total dose of intraoperatively fentanyl(during the procedure/surgery)
- Postoperative pain severity(up to 24 hours postoperative)
- Number of patients needed rescue analgesia(up to 24 hours postoperative)
研究者
Amr Arafa Elbadry
Principal Investigator
Tanta University