Ultrasound-Guided Mid-Transverse Process to Pleura Block for Analgesia in Pediatric Thoracotomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The total dose of morphine consumption in the first postoperative 24 hours.
研究概览
简要总结
The aim of this study is to assess the effectiveness of analgesia of US guided MTP block in pediatrics undergoing thoracotomy.
详细描述
Pain following surgery is a universal phenomenon which up to now is often underestimated and undertreated especially in pediatrics. Any postoperative analgesic technique should meet three criteria, which are effectiveness, universal applicability and safety.
Thoracotomy is widely known to cause severe acute pain. This pain can be very distressing for both children and their parents. If not treated properly, it may acutely cause ventilation-perfusion disorder and hypoxemia, together with a change in lung mechanics. It may lead to a delay in recovery, with some long-term sequelae. As a part of multimodal analgesia, many regional blocks have been described.
Regional anesthesia techniques are increasingly used in all surgical settings. Even in the context of thoracic surgery, new peripheral regional anesthesia techniques are being tested as alternatives to those already used. This proliferation of new techniques is explained, on the one hand, by the evolution of surgical techniques, which are becoming less and less invasive, and on the other hand, by the frequency and severity of the complications induced by thoracic epidural anesthesia and paravertebral block - currently the gold standards in context of pediatric setting.
Paravertebral block (PVB) has gained more popularity than other regional analgesic techniques including epidural for perioperative analgesia in pediatric surgery. Thoracic PVB provides adequate postoperative analgesia with favorable adverse effects. The use of thoracic PVB is associated with decreased pain severity and opioid consumption in both adults and children.
Many clinicians hesitate to apply the PVB technique due to the risk of serious complications such as pneumothorax. Therefore, the safest and most effective methods are being tried by clinicians. In a study conducted on cadavers claimed that mid-transverse process to pleura (MTP) block (an injection point midway between the pleura and posterior border of the transverse process) provides a paravertebral block due to the paravertebral spread of the local anesthetic agent through fenestrations and septations in the superior costotransverse ligament. They thought that MTP block may be as effective as PVB in postoperative pain management with less risk of possible complications.
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)
入排标准
- 年龄范围
- 2 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will include 50 pediatric patients of both sexes aged from 5 to 15 years old with American Society of Anesthesiologists physical status I& II undergoing elective open thoracotomy.
排除标准
- •Refusal of parents.
- •Repeated thoracotomy.
- •Emergency surgery.
- •Mechanically ventilated patients.
- •Bleeding disorders.
- •Allergy to study drugs.
- •Infection at the site of the needle puncture.
研究组 & 干预措施
Patients undergoing pediatric thoracotomy will receive general anesthesia alone.
the patients will receive general anesthesia alone. Anesthesia will be induced by inhalation of sevoflurane at 8% concentration which will decreased gradually down to 2% concentration carried by 100% oxygen, with loss of consciousness; a peripheral intra venous cannula with suitable size will be inserted, then the neuromuscular blockade will be facilitated by cisatracurium 0.15 mg/ kg to allow tracheal intubation with appropriate sized endotracheal tube. Fentanyl 1μg/ kg will be given and anesthesia will be maintained with air and O2 (50:50) and along with 2% end tidal concentration of sevoflurane to control the depth of anesthesia. At the end of surgery residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes.
general anesthesia and ultrasound guided MTP block
midpoint between the transverse process and the pleura 0.5mL/kg 0.25% bupivacaine will be injected.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The total dose of morphine consumption in the first postoperative 24 hours.
时间窗: 24 hours postoperative
The total dose of morphine consumption in the first postoperative 24 hours.
次要结局
- Diaphragmatic excursion will be measured preoperative and postoperative in post anesthesia care unit (PACU).(Immediately 15 minutes preoperative and 15 minutes postoperative)
- Pain will be assessed by the face, legs, activity, cry and consolability (FLACC) score in children at 1, 2, 6, 12, 18 and 24 hours postoperative.(1, 2, 6, 12, 18 and 24 hours postoperative.)
- Total intraoperative fentanyl consumption (μ/kg) starting from induction of anesthesia till the end of surgery.(from induction of anesthesia till the end of surgery.)
研究者
Heba Salah Eldin Gawish
Principal investigator
Tanta University