Analgesic Efficacy of Mid-point Transverse Process to Pleura Block Compared With Thoracic Paravertebral Block in Adult Patients Undergoing Posterolateral Thoracotomy Incisions: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- The total postoperative fentanyl consumption
研究概览
简要总结
The ultrasound guided Thoracic paravertebral (TPV) block in the context of posterolateral thoracotomy offers targeted pain relief by anesthetizing the spinal nerves as they emerge from the intervertebral foramina, producing ipsilateral somatosensory, visceral and sympathetic nerve blockade. TPV block involves the injection of local anesthetic (LA) into the wedge-shaped paravertebral space deep to the superior costotransverse ligament (SCTL)
Costach et al introduced the mid-point transverse process to pleura block (MTP) as a modification of conventional paravertebral block by placing the LA posterior to the (SCTL) under ultrasound guidence achieving an effective block without the necessity to approach the pleura and the attendant risks.
In recent studies ,the ultrasound guided MTP block provided an effective analgesia in various surgical procedures including mastectomy , video-assisted thoracic surgeries and cardiac surgeries.
In our study we hypothesized that the mid-point transverse process to pleura (MTP) block can provide an effective analgesia comparable with thoracic paravertebral (TPV) block in adult patients undergoing posterolateral thoracotomy incisions.
详细描述
After approval of the local institutional ethics committee and local institutional review board. Patients who are scheduled for elective thoracic surgeries via posterolateral thoracotomy incision and fulfilling the inclusion criteria in Fayoum university hospital starting from March 2024 will be enrolled in this randomized controlled study until fulfilling sample size. A detailed informed consent will be signed by the eligible participants before recruitment.
The patients will be randomized into two groups: MTP block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments.
In this study, no premedication will be given to the patients before the operation. All patients will be monitored using electrocardiography, pulse-oximetry, capnography. An arterial line will be inserted using a 20 G cannula either right or left radial artery for invasive blood pressure monitoring in the operating room.
After pre-oxygenation, general anesthesia will be induced with intravenous propofol (2 mg/kg) and fentanyl (1 μg/kg). After muscle relaxation with atracurium (0.5mg/kg), tracheal intubation will be performed by a cuffed endotracheal tube (7-7.5) size and mechanical ventilation will be applied while maintaining the end-tidal CO2 between 30 and 35 mmHg. Maintenance of anesthesia will be made using inhalational anesthesia (isoflurane) and IV atracurium according to the patients' requirements. The anesthesia will be maintained with isoflurane starting at one MAC and will be adjusted to obtain an adequate level of anesthesia by titrating the concentration according to the BIS monitoring (BIS Complete Monitoring System P/N 185-0151 Covidien IIc, 15 Hampshire Street, Mansfield, MA 02048 USA) to keep the BIS value between 40 and 60.
After induction , the patient will be placed in the lateral decubitus position. The same anesthesiologist will perform the block.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The patients will be randomized into two groups: MTP block group and TPV block group in a 1:1 ratio using a computer-generated random table. The patient's assigned group information will be elicited from a sealed opaque envelope by the anesthesiologist who will perform the US-guided MTP and TPV block and will not be involved in further data collection or patient care. The patients and both the surgical and anesthesia teams, who are responsible for patient care and data collection are blinded from the group assignments
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Scheduled for elective thoracic surgery for pneumectomy, lobectomy, bullectomy or pleural decortication via posterolateral thoracotomy incision.
- •American Society of Anesthesiologists (ASA) physical status I-III patients
排除标准
- •Patient refusal.
- •Significant renal, hepatic and cardiovascular diseases.
- •History of allergy to one of the study drugs.
- •Any contraindication to regional anesthesia such as local infection or bleeding disorders.
- •Chronic opioid use, history of chronic pain and cognitive disorders.
- •Emergent or re-do surgeries
研究组 & 干预措施
mid-point transverse process to pleura (MTP) block
In MTP block group, A 22G, 50mm block needle (SONOTAP,Pajunk, -Geisingen,Germany) will be inserted in the cranial to caudal direction via an in-plane approach between the 2 transverse processes and advanced till it reaches the mid-point between the transverse process and pleura. After negative aspiration of blood or air, a total volume of 20 ml of bupivacaine 0.25% ( not exceeding a maximum dose of 2 mg/kg) will be injected superficial to the SCTL
干预措施: mid-point transverse process to pleura (MTP) block (Procedure)
Thoracic Paravertebral (TPV) Block
In the TPV block group , the transverse process and the pleura will be identified and the needle will be inserted in the cranial to caudal direction till it pierces the SCTL and reaches the paravertebral space. After negative aspiration of blood or air a total volume of 20 ml of bupivacaine 0.25% will be injected displacing the pleura downwards
干预措施: Thoracic Paravertebral Block (Procedure)
结局指标
主要结局
The total postoperative fentanyl consumption
时间窗: in the first 24 hours
The total 24 h. fentanyl consumption will be calculated based on the volume remaining in the PCA after 24h based on the following formula : Total fentanyl consumption = (total volume - remaining volume )x 10 .
次要结局
- Demographic data(24 hours before operation)
- intra operative fentanyl consumption(from induction of anesthesia to extubation)
- Duration of surgery(from induction of anesthesia to extubation)
- Blood pressure(from induction of anesthesia up to 24 hours post operative)
- Oxygen saturation(from induction of anesthesia up to 24 hours post operative)
- complications related to the block(from induction of anesthesia up to 24 hours post operatively)
- complications related to IV opioids(assessed up to 24 hours postoperatively)
- Heart rate(from induction of anesthesia up to 24 hours post operative)
- Participant satisfaction(from the operative day; to the time of discharge up to 30 days)
- visual analogue scale score both during rest and with cough(from 30 minutes up to 24 hours postoperative)
- Hospital length of stay in days(the time elapsed from day 0; the operative day; to the time of discharge up to 30 days)
研究者
Mohamed Ahmed Hamed
Associate professor of Anesthesiology
Fayoum University Hospital