Erector Spinae Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy, is It a Promising Alternative Modality?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- 24 hours Postoperative Total Opioid Consumption.
研究概览
简要总结
Adequate analgesic regimen is one of the most important key elements of Enhanced recovery after surgery (ERAS) protocols. The cornerstone of analgesia is multimodal analgesia combining local anesthetic (LA) techniques and trying to avoid parenteral opioids and their side effects. Subcostal approach to Anterior quadratus lumborum block (SAQLB), compared to other variants of quadratus lumborum blocks (QLBs), was associated with wider and longer sensory blockade, and provided somatic as well as visceral analgesia of the abdomen. The newly emerging, relatively easy erector spinae plane block (ESPB) provided excellent analgesia across a variety of surgical procedures and reduced opioid consumption. This motivated us to do this study to assess and compare the analgesic efficacy of ESPB versus SAQLB following laparoscopic cholecystectomy.
详细描述
Site of the Study: Zagazig university surgical hospitals.
Type of the Study: Prospective randomized double-blinded clinical trial.
Sample Size:
The sample size is calculated to be 27 for each group, assuming that the mean ± standard deviation of 24 hrs postoperative total opioid consumption among group of patients undergoing ESBP technique versus control group is 130 ± 88 and 201 ± 78, respectively. Assuming that US-guided SAQLB will be similar to ESBP technique in 24 hrs postoperative total opioid consumption. with confidence level of 95% and power of test 80%, with 10% drop out.
Withdrawal Criteria:
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
- Double (Participant, Outcomes Assessor)
盲法说明
Computer-generated randomization numbers will be used to randomly assign patients into 3 groups using sealed opaque envelopes that will be randomly selected by each patient and contained a group number in which the patient was enrolled. Once enrolled in the study, patients will be randomly assigned into 3 groups;
Group I (ESP Group): will receive US-guided ESPB. Group II (AQL Group): will receive US-guided AQLB. Group III (Control Group): will receive IV multimodal analgesia only.
Both patients and data collector responsible for assessing outcomes will be blinded to group assignment (double-blinded clinical trial).
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 60 years, of both sexes.
- •ASA class II - III.
- •Scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
- •Body mass index (BMI) ≥ 30 kg/m².
排除标准
- •1. Age < 18 or > 60 years.
- •ASA IV patients.
- •Intraoperative conversion to open surgery.
- •Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy or infection at the site of injection.
- •6. Uncooperative patients or psychiatric disorders.
- •Spinal deformity or previous spine surgery.
- •Chronic use of analgesics or drug dependence. chronic pain characterized by opioid use for > 30 consecutive days within the 3 preoperative months at a dose equivalent to at least 15 mg of morphine.
研究组 & 干预措施
Ultrasound Guided Erector Spinae Plane Block
Patient will be placed in lateral decubitus position. By palpation of spinous processes starting from C7 downward, T7 spinous process will be located. Under complete aseptic precautions, linear probe of US machine will be placed in a transverse orientation at this level to identify tip of T7 transverse process (TP). By probe rotation into a longitudinal orientation, a parasagittal view will visualize skin and subcutaneous tissue, trapezius, and erector spinae (ES) muscle layers superficial to TPs. After local anesthetic (LA) infiltration, a 20 gauge spinal needle will be inserted in-plane and directed cranio-caudally until it contacts T7 TP. Target site for injection will be fascial plane deep to ES muscle. 1 mL saline will be injected to confirm correct needle-tip position by visualization of lifting of ES muscle off TP without distending the muscle and spreading cranio-caudally. 30 mL of 0.25% bupivacaine will be injected. Procedure will be performed bilaterally.
干预措施: Ultrasound Guided Erector spinae plane block (Procedure)
Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block
Patients will be positioned lateral decubitus. A curvilinear 2-5 MHz ultrasound transducer (SonoSite S-Nerve, Bothell, WA) will be positioned posteriorly below the 12th rib in a parasagittal oblique plane at L1-2 level. The QL muscle was visualized and its point of insertion on the 12th rib identified. An 18-gauge Tuohy needle was advanced in the caudal-to-cranial direction between QL muscle and the psoas major muscle until a click could often be felt as the needle tip penetrated the anterior investing fascia of the QL muscle. After a negative aspiration, 30 mL of 0.25% bupivacaine was injected through the needle to help confirm the final needle tip position, anterior to the QL muscle at close proximity to the 12th rib.
干预措施: Ultrasound Guided Subcostal Anterior Quadratus Lumborum Block (Procedure)
Intravenous Multimodal Analgesia
Postoperative pain in the post-anesthesia care unit (PACU) and on the ward will be treated with a combination of IV multimodal analgesia in the form of Acetaminophen (15 mg/kg 4/day) and Ketorolac (0.5 mg/kg 3/day) using a fixed scheme. In addition, Nalpuphine, as 3 mg IV bolus at each dose, will be given when Numerical Rating Scale (NRS) ≥ 3. VAS will be assessed 5 - 10 min. after each opioid dose to assess the need for additional opioid doses.
干预措施: Intravenous Multimodal Analgesia (Other)
结局指标
主要结局
24 hours Postoperative Total Opioid Consumption.
时间窗: First 24 hours Postoperative
24 hours Postoperative Total Opioid Consumption.
次要结局
- Time to First Ambulation.(First 24 hours Postoperative)
- Time of Performing the Block.(Intraoperative (Time from placement of US probe on the patient's skin till the end of local anesthetic injection.))
- Time of Postoperative First Opioid Analgesic Request.(First 24 hours Postoperative)
- Postoperative NRS Scores(First 24 hours Postoperative)
- Postoperative Complications(First 24 hours Postoperative)
研究者
Ashraf Torki
Lecturer of Anesthesia, Zagazig University
Zagazig University