Comparison of Posterior Transversus Abdominis Plane Block Combined With Sacral Multifidus Plane Block Versus Posterior Transversus Abdominis Plane Block for Laparoscopic Colorectal Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual analogue pain score (VAS)
研究概览
简要总结
The aim of this study is to compare perioperative analgesic efficacy and safety profile of combined SMPB and posterior TAP block versus posterior TAP block in patients undergoing laparoscopic colorectal cancer surgery.
详细描述
On arrival of the patients to operating room, patients will be secured with 20 gauge intravenous cannula. Monitoring will include ECG, non-invasive arterial blood pressure (NIBP), and pulse oximeter (SpO2). Before receiving general anesthesia, patients will be randomly assigned into one of the two study groups; SMPB with TAP block Group and TAP block Group.
Induction of general anesthesia will be induced with patients after adequate preoxygenation using 1 µg/kg fentanyl (based on lean body weight), 2 mg/kg of propofol (based on total body weight) and 0.5 mg/kg of atracurium (based on the ideal body weight), in addition to 8mg IV dexamethasone for prevention of postoperative nausea & vomiting. Endotracheal intubation will be established. Anesthesia will be maintained by 1.2% MAC of isoflurane with oxygen (50%) in air and 0.1 mg/kg of atracuri¬um will be administered every 20 minutes as main¬tenance anesthetic drugs. Volume-controlled ventilation will be maintained with a tidal volume of 6 mL/kg of ideal body weight and the respiratory rate will be adapted to maintain ET CO2 between 30 and 40 mmHg. Moni¬toring through ECG, NIBP, pulse oximeter and capnograph (ETCO2) continued throughout the surgeries.
US (Siemens ACUSON X300 Ultrasound System) guided blocks will be administered immediately after the induction of anesthesia and prior to surgical incision by consultant anesthesiologist who had experience in regional anesthesia and were familiar with the SMPB & TAP blocks. To achieve double blinding, patients will receive the block by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients intraoperative and postoperative.
SMPB & TAP Block Group (ST-Group): this group will receive bilateral ultrasound-guided SMPB & TAP block TAP block Group (T-Group): this group will receive bilateral ultrasound-guided TAP block Technique of SMPB block: sacral foramen injection technique The patient in lateral position. A curvilinear ultrasound probe (5-7 MHz) will be placed longitudinally in the midline just above the median sacral crest. After identifying the hyper echoic median sacral crest with the overlying hypo echoic latissimus dorsi muscle, the probe will be moved laterally to identify the intermediate crest, the dorsal sacral foramina (DSF), longissimus thoracic muscle, and multifidus muscle (MFM). After optimizing the image at the S2 level, a 21G 80 mm block needle will be advanced in an in plane approach until the needle reached the sacral foramen. A distinct loss of resistance will be felt once the needle pierced the fibrous covering of S2 foramen. After negative aspiration, a total of 20 mL bupivacaine 0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side(15) Technique of TAP Block: posterior approach The patient in semi-lateral position. A linear ultrasound probe (4-12MHz) will be placed posterior to the mid-axillary line between the costal margin and the iliac crest. When scanning posteriorly, transversus abdominis tailed off and turned into aponeurosis. Subsequently, a blunt-ended needle will be introduced into the TAP between the internal oblique and transversus abdominis, posterior to the mid-axillary line and near the aponeurosis. After confirmation with saline solution into the facial plane, as the appearance of a hypo echoic ellipsoid with well-defined margins on ultrasound imaging. After negative aspiration, a total of 20 mL bupivacaine0.1875% ( 0.19%) will be injected in incrementally, aspirating every 5 ml and the block will be repeated on the other side(16).
The surgery can begin after 15 minutes from block time which is the usual time for sterilization.
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
Double
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 90 years
- •Male or female
- •ASA class I to III
- •Elective laparoscopic or robotic colorectal surgery with or without resections requiring perineal incisions.
排除标准
- •Patient refusal
- •History of previous abdominal surgery, preoperative bowel obstruction symptoms, and requirement for emergency surgery
- •Conversion to open laparotomy
- •Coagulopathy, infection at the injection site, allergy to local anesthetics, body mass index > 30 kg/m2, severe hepatic or renal disease, severe cardiopulmonary disease (≥ ASA IV), diabetic or other neuropathies, patients receiving opioids for chronic analgesic therapy, inability to comprehend visual analogue scale (VAS) and patients transferred to the intensive care unit (ICU) post-surgery.
结局指标
主要结局
Visual analogue pain score (VAS)
时间窗: 2 hours
(VAS) at rest and during coughing at 2hr postoperative.
次要结局
- Incidence of postoperative nausea and vomiting(24 hours)
- Time to first flatus & development of postoperative ileus(24 hours)
- Fentanyl consumption(6 hours)
- Time to first postoperative analgesic request(24 hours)
- Total morphine requirements(24 hours)
- Visual analogue pain score (VAS)(24 hours)
- Quality of Recovery (QoR-15) scale(24 hours)
- Incidence of complications(24 hours)
