A Prospective Randomized Controlled Comparative Study of Combining Ultrasound Guided Superficial Cervical Plexus Block with Clavipectoral Fascial plane Block and Interscalene Brachial Plexus Block using 0.375% Ropivacaine for Elective Clavicle Surgeries.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The time at which the first use of rescue analgesic drug.
研究概览
简要总结
The aim of my study is to compare the application of Ultrasound guided superficial cervical plexus block combined with clavipectoral fascial plane block or interscalene brachial plexus block in elective clavicle fractures using 0.375% Ropivacaine with respect to duration of analgesia and incidence of hemidiaphragmatic paresis or paralysis.
As institutional ethical committee approval obtained, written and informed consent will be taken from the patient. The study will be conducted in 100 patients between 18 to 60 years of age, ASA-I and ASA-II of either gender with fracture of clavicle electively posted for open reduction and internal fixation Patients will be randomly allocated into one of the following groups Group I and Group II using computer generated random number table
Group I: Patients in this group will receive superficial cervical plexus block with 7 ml of 0.375% Ropivacaine and clavipectoral fascial plane block with 20 ml of 0.375% of Ropivacaine under ultrasound guidance
Group II: Patients in this group will receive superficial cervical plexus block with 7 ml of 0.375% Ropivacaine and interscalene brachial plexus block using 20 ml of 0.375% ropivacaine under ultrasound guidance
All the patients in the study will be subjected to a thorough pre-anaesthetic evaluation which includes a detailed history taking, complete general physical examination and necessary relevant investigations like complete blood count, blood urea, serum creatinine, chest X-ray, ECG, bleeding time, clotting time. All the patients will be kept nil per oral 8-10 hours for solids and 2 hours for clear fluids. Tablet Alprazolam 0.5 mg and Tablet Pantoprazole 40 mg will be given on the night before surgery. And, at 6 AM on the day of surgery, Injection Pantoprazole 40 mg will be given intravenously. For administration of fluids and drugs, 18G intravenous line will be secured.
The patient will be shifted to pre-operative room and multiparameter monitor will be connected and intravenous fluids will be connected and pre-operative heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation, ECG and Diaphragm excursion movement using Ultrasound will be recorded. The superficial cervical plexus block and clavipectoral fascial plane block using 0.375% ropivacaine for Group A patients and superficial cervical plexus block and interscalene brachial plexus block using 0.375% ropivacaine for Group B patients will be given under ultrasound guidance
ULTRASOUND GUIDED SUPERFICIAL CERVICAL PLEXUS BLOCK:
The patient will be placed in a supine position with the head turned to the opposite side of fracture for adequate exposure of the neck and the upper chest. Under strict aseptic precautions, A high-frequency linear ultrasound probe will be placed at the lateral aspect of neck at the level of cricoid cartilage, Once the sternocleidomastoid muscle is identifed, the probe will be moved posteriorly until the posterior tapering end of the muscle is identified. Then, the superficial cervical plexus (SCP) and investing layer of deep cervical fascia will be visualized and 26 Gauge 1.5 inch needle will be introduced by in-plane technique until its tip reaches near the superficial cervical plexus. After careful negative aspiration to exclude intravascular placement, 7 mL of 0.375% ropivacaine will be deposited.
ULTRASOUND GUIDED CLAVIPECTORAL FASCIAL PLANE BLOCK:
The patient will be placed in a supine position with the head turned to the opposite side of the fracture and the shoulder will be padded with a small pillow. Under strict aseptic precautions, A high frequency linear probe will be placed on either side of fractured site on anterior surface of the clavicle and 26 Gauge 1.5 inch needle will be introduced by in-plane technique from caudal to cephalad direction until its tip reaches between periosteum of clavicle and clavipectoral fascia. After careful negative aspiration to exclude intravascular placement, 10 mL of 0.375% ropivacaine will be deposited on either side of fracture site.
ULTRASOUND GUIDED INTERSCALENE BRACHIAL PLEXUS BLOCK:
The patient will be placed in a supine position with the head turned to the opposite side of the fracture and the shoulder will be padded with a small pillow. Under strict aseptic precautions, a high frequency linear probe will be placed at the level of cricoid cartilage to visualize the roots of brachial plexus located between the anterior and middle scalene muscles and 26 Gauge 1.5 inch needle will be introduced by in-plane technique to reach near C5 and C6 nerve roots. After careful negative aspiration to exclude intravascular placement, 20 mL of 0.375% ropivacaine will be deposited to achieve its spread between C5 and C6 nerve roots.
The sensory block, motor block and analgesic duration is assessed using the scales as entered previously in our Part 7 of Trail Registration steps. The diaphragm excursion movement will be assessed using ultrasound during normal tidal volume breaths and deep breaths before giving block and 30th minute and 4th hour after giving the block in both the groups and the incidence of hemi-diaphragmatic paresis or paralysis is assesed
DIAPHRAGM EXCURSION MOVEMENT:
Patient will be placed in a supine position. By using low frequency curvilinear probe of ultrasound the diaphragm will be focussed by keeping it longitudinal at the level of anterior axillary line in subcostal region. Then Motion mode (M-Mode) of the diaphragm is used to detect diaphragmatic excursion along a line selected perpendicular to the diaphragm. Two representative images of diaphragmatic excursion will be saved during tidal volume breath and deep breath respectively. The excursion amplitude will be measured as upright perpendicular distance from minimum to maximum point of diaphragmatic excursion. Diaphragm excursion measurement will be done before giving block as preblock value and after giving block at 30th minute and 4th hour. Hemidiaphragmatic paralysis is defined as more than 50% reduction in diaphragmatic excursion compared with preblock value during deep breaths and/or Paradoxical movements of diaphragm after 30 minutes of giving block
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients belonging to American Society of Anaesthesiologists Physical Status I and II.
- •Patients undergoing elective surgery for clavicle fractures.
排除标准
- •Patients refusing for the procedure.
- •Patients with history of allergy, sensitivity or any kind of reactions to local anesthetic agents.
- •Patients with coagulation abnormalities.
- •Patients with cardiovascular and cerebrovascular diseases.
- •Patients with infection at the injection site.
- •Patients with history of Chronic Obstructive Pulmonary Disease and Pleural effusion.
结局指标
主要结局
The time at which the first use of rescue analgesic drug.
时间窗: Pain will be assessed using Pain Score : Visual Analogue Scale at 6th , 12th and 24th hour postoperatively
This will be assessed in the postoperative period after the surgery.
时间窗: Pain will be assessed using Pain Score : Visual Analogue Scale at 6th , 12th and 24th hour postoperatively
次要结局
- The sensory effect of all the blocks will be assessed in three areas:(sternoclavicular joint,)
- The motor effect of all the blocks will be assessed preoperatively after giving block at shoulder joint, elbow joint, wrist joint, metacarpophalangeal & interphalangeal joints of fingers(The motor effect will be assessed)
- Diaphragm excursion measurement will be done during normal tidal volume breaths & deep breaths before giving(block preoperatively & also intraoperatively & also postoperatively)
研究者
K Muni Sruthi
Navodaya Medical College Hospital and Research Centre
