Effect of Ultrasound Guided L1,L2 Paravertebral Block in Decrease the Requirements for Hypotensive Drugs During General Anesthesia in Patients Undergoing Hip Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Dose of hypotensive drugs
研究概览
简要总结
The paravertebral block (PVB) is a block of the mixed nerve soon after it exits the intervertebral foramen.(2) It provides intense unilateral analgesia of long duration and has become the primary anesthetic for many applications.(3) Paravertebral Block (PVB) involves injection of local anaesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anaesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.(4) The increasing demand for hip arthroplasties over the last decades has sparked the creation of new and innovative anesthetic techniques and analgesic pathways with the goal to support best possible outcomes among this frequently elderly patient population. As a result, today different perioperative treatment pathways are available to physicians and their patients. In this context, the focus has shifted to techniques based on regional anesthetic and analgesic techniques. This trajectory has been fueled by a number of advantages including effective, long-lasting and focused pain control, decreased need for systemic analgesics and earlier mobilization.
详细描述
Paravertebral block group: The patient will be reviewed then moved to the block area. Intravenous access, commencement of IV crystalloid, and standard patient monitoring with ECG , NIBP , pulse oximetry Sedation 2 mg midazolam and oxygen will be commenced prior to insertion of the block.
The equipments area 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle), Skin antiseptic solution, Sterile gloves, marking pen, 1-2 ml of 1% lignocaine for skin infiltration and 20 ml of 0.25% Bupivacain.
The patient will be positioned in lateral decubitus position with the side to be blocked upward and supported by an attendant. The back should assume kyphosis.
The following boney surface anatomy landmarks are helpful to identify spinal levels and to estimate the position of the transverse processes: Iliac crest (corresponds to L3-4 or L2-3), Spinous processes (midline) , Tips of scapulae (corresponds to T7), Midline and 2.5 cm lateral to the midline.
The level between L1 and L2 will be identified using ultrasound as well as transverse processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge, 8 cm Tuohy needle (Perifix Epidural Needle) will be advanced until it made contact with the transverse process. The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25 %( 10ml for each level) will be injected slowly after negative aspiration was confirmed at each level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
盲法说明
The patients were randomized to two groups using a computer-generated list and kept in a sealed envelope into two groups:
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients from 20 to 60 years.
- •Genders eligible for study: both.
- •ASA I-II.
- •No contraindications for application of regional anesthesia as Patient refusal, local anesthetic, allergy, local sepsis or infection at puncture site, INR > 1.5 or < 12 hours post LMWH.
排除标准
- •Extremes of age.
- •ASA III-IV.
- •Hypovolemia.
- •Increased intracranial pressure.
- •Coagulopathy or thrombocytopenia less than 100000/ml.
- •Sepsis (increased risk of meningitis).
- •Infection at the puncture site.
- •Pre-existing neurologic disease.
- •Patient refusal.
- •History of allergy to local anesthetic.
研究组 & 干预措施
Paravertebral block Group
Patients will receive single shot L1-L2 PVB before undergoing GA Full monitoring with ECG , NIBP , puls oximetry will be applied. The level between L1 and L2 will be identified using U/S as well as transverse processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A 22-gauge Tuohy needle will be advanced until it made contact with the transverse process. The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25% will be injected slowly To control intraoperative blood pressure, fentanyl will be used as well as hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.
干预措施: Ultrasound guided PVB with General Aneasthesia (Procedure)
Paravertebral block Group
Patients will receive single shot L1-L2 PVB before undergoing GA Full monitoring with ECG , NIBP , puls oximetry will be applied. The level between L1 and L2 will be identified using U/S as well as transverse processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A 22-gauge Tuohy needle will be advanced until it made contact with the transverse process. The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25% will be injected slowly To control intraoperative blood pressure, fentanyl will be used as well as hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.
干预措施: Ultrasound (Device)
Paravertebral block Group
Patients will receive single shot L1-L2 PVB before undergoing GA Full monitoring with ECG , NIBP , puls oximetry will be applied. The level between L1 and L2 will be identified using U/S as well as transverse processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A 22-gauge Tuohy needle will be advanced until it made contact with the transverse process. The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25% will be injected slowly To control intraoperative blood pressure, fentanyl will be used as well as hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.
干预措施: Paravertebral block (Drug)
Paravertebral block Group
Patients will receive single shot L1-L2 PVB before undergoing GA Full monitoring with ECG , NIBP , puls oximetry will be applied. The level between L1 and L2 will be identified using U/S as well as transverse processes depth. Insertion points will be marked 2.5 cm lateral to the superior aspect of corresponding spinous processes, A 22-gauge Tuohy needle will be advanced until it made contact with the transverse process. The needle will be withdrawn slightly and walked off caudally to an additional depth of 1 cm. Once this is reached, 20cc of bupivacaine 0.25% will be injected slowly To control intraoperative blood pressure, fentanyl will be used as well as hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.
干预措施: General Aneasthesia (Drug)
General anesthesia Group
Patients will receive only GA All patients in the study will receive GA in the form of propofol 2mg/kg , atracurium 0.5ml/kg ,fentanyl 100 microgram in induction with ETT and mechanical ventilation , full monitoring with ECG , NIBP and puls oximetry will be applied.
To control intraoperative BP,fentanyl will be used as well as,hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.
To achieve post operative analgesia, intravenous paracetamol( 1gram ) and pethidine IV (50 mg ) will be added when needed
干预措施: Ultrasound (Device)
General anesthesia Group
Patients will receive only GA All patients in the study will receive GA in the form of propofol 2mg/kg , atracurium 0.5ml/kg ,fentanyl 100 microgram in induction with ETT and mechanical ventilation , full monitoring with ECG , NIBP and puls oximetry will be applied.
To control intraoperative BP,fentanyl will be used as well as,hypotensive drugs ( propranolol and nitroglycerine and the total dose will be recorded.
To achieve post operative analgesia, intravenous paracetamol( 1gram ) and pethidine IV (50 mg ) will be added when needed
干预措施: General Aneasthesia (Drug)
结局指标
主要结局
Dose of hypotensive drugs
时间窗: One day postoperatively
Required dose of hypotensive drugs in both groups
次要结局
- Pain assessment(One day postoperatively)
- Total dose of opioids(One day postoperatively)
研究者
Ahmed Abdalla
Assistant Professor of Anesthesia&I.C.U and Pain Clinic
Cairo University