Bilateral External Oblique Intercostal Plane Block (EOIPB) an Alternative Analgesic Technique in Patients Scheduled for Laparoscopic Cholecystectomy: A Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- total morphine consumption
研究概览
简要总结
Pain after laparoscopic cholecystectomy (LC) is a common complaint that prolongs hospital stay and thus increases morbidity. There are three primary sources of pain after LC, incision site, local and systemic effects of pneumoperitoneum, and post cholecystectomy wound to the liver. External oblique intercostal plane block (EOIPB) has recently been described as a novel block for upper abdomen surgery. the probable mechanism of the block with the dyeing of both the anterior and lateral branches of the intercostal nerves T7-T10. This block also provides a dermatomal sensory block at the T6-T10 level in the anterior axillary region and the T6-T9 level in the midline.
详细描述
EOIPB has the benefit of being performed with the patient supine when compared with QLB and ESPB. It also has an advantage over SIPB in that it produces greater analgesia throughout the midline of the abdomen. The hypothesis of this randomized study is that patients who will undergo EOIPB will have lower opioid consumption in the postoperative period than patients who receive routine multimodal analgesia alone. The study aims to assess pain control in the immediate postoperative period by assessment of Numerical Rating scale (NRS), time for the first analgesic request as well as total morphine intake in the first 24 hours after surgery.
Study design:
This is a prospective, randomized double blinded control study which will be conducted in department of anesthesia and surgical Intensive care unit at Theodor Bilharz Research Institute after approval by research ethics committee and patient informed consent. 50 patients will be enrolled in the study and divided into two groups either (EOIPB group (E) or Control group (C). Randomization will be done by allocation 1:1 of scheduled cases per day.
Sample size: 38 patients
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
the investigator responsible for block administration will not be aware of the content of the medications prepared whether they are the local anesthetics or normal saline. also the patients will not be aware of the group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective laparoscopic cholecystectomy with estimated pneumoperitoneum time of 60 to 90 min.-
排除标准
- •Coagulation disorders.
- •Liver/ kidney disease
- •Previous abdominal surgery
- •Infection in the block site
- •Chronic opioid use
- •Local anesthetic (LA) allergy,
- •Pregnancy, or BMI ≥35 kg/m2
- •Duration of surgery (≥ 2.5 h due to surgical complications), -
研究组 & 干预措施
The EOIPB ( E) group
EOIPB will be administered by a single anesthetists following the intubation. A linear ultrasound transducer is positioned in the sagittal plane at the 6th rib level, between the anterior axillary and midclavicular lines. The ribs, lungs, pleura, intercostal muscles, external oblique muscle and subcutaneous tissue are visualized in the image. The in-plane technique with a 22G, 80 mm block needle is used to inject 30 ml of 0.25% bupivacaine into the external oblique intercostal plane on both sides.
干预措施: local anesthetic injection (bupivacaine) (Drug)
The Control Group (C)
Control group of patients will receive standard multimodal analgesia. Using us guidance, the external oblique intercostal plane is identified and 30 ml normal saline instead of LA will be injected in the control group.
干预措施: normal saline injection (Other)
结局指标
主要结局
total morphine consumption
时间窗: the first 24 hours postoperatively
the total analgesic (morphine) requirements in the first 24 hours postoperatively will be calculated
次要结局
- NRS(6 hours postoperatively)
研究者
Moshira sayed mohamed
Assistant lecturer
Theodor Bilharz Research Institute