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临床试验/CTRI/2024/12/077922
CTRI/2024/12/077922尚未招募不适用

Ultrasound guided Retroclavicular vs Supraclavicular brachial plexus block in upper limb surgery: A Randomized comparative study

Spoorthi V1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年12月20日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
Success Rate

研究概览

简要总结

After obtaining institutional ethical committee approval, written and Informed consent will be taken from the patient.

The study will be conducted in 90 patients between 18 to 60 years of age , ASA physical status1 and 2 of either gender with elective upper limb surgeries of forearm and hand surgeries.

Patients were randomly allocated in to one of the following groups of 45 each.

Group RC-Retroclavicular approach Group

Group SC-Supraclavicular approach Group

All the patients in the study will be subjected to a thorough pre-anesthetic evaluation which includes a detailed history taking, complete general physical examination and necessaryr elevant investigations like complete blood count,blood urea, serum creatinine, chest X ray, ECG, Bleeding time, Clotting time, random blood sugar, and urine analysis (Sugar,Albumin and microscopy).

All the patients will be kept Nil per oral according to standard guidelines. Tablet Alprazolam 0.5mg and Tablet Pantoprazole 40mg will be given on the day before surgery, at 6AM on the day of surgery Injection Pantoprazole 40mg will be given. For administration of fluids and drugs, Intravenous line will be secured. Pre-operatively, The Numerical Rating Scale will be explained to the patient, and intensity of pain will be evaluated on a scale of 0-10.

A score of 0 indicates No Pain, while a score of 10 indicates worst possible pain. The patient will be shifted to preoperative room and multiparameter monitor will be connected and preoperative Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure, Respiratory Rate, Oxygen Saturation, ECG will be recorded and Intravenous fluids will be connected.

USG GUIDED RETROCLAVICULAR AND SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK

All the patients will receive 20ml of 0.5% Ropivacaine. The patient is made to lie in supine position with head end angled at 45 degrees to the ipsilateral arm placed adducted by the patient’s side. Procedure is performed by Experienced anesthesiologist. The skin over the needle insertion site i.e., Supraclavicular area will be prepared with 5% povidine iodine solution. Block will be performed by using 6 to 12mHz frequency Linear probe of GE logic C5 premium USG machine.

In Supraclavicular approach, the probe will be placed over the Supraclavicuar fossa, parallel to the clavicle to obtain a view of the divisions of the brachial plexus which appears as a cluster of hypoechoic structure and subclavian artery which is seen as a pulsating structure over 1st rib. After the skin is infiltrated with local anesthetic mixture, a 50mm 20G insulated short Beverley stimulation needle (stimuplex A, B Braun) will be inserted using in plane technique in a lateral to medial direction until the needle tip is positioned at the junction of 1st rib and subclavian artery.

Once the needle tip penetrates Brachial plexus sheath on ultrasound, after negative aspiration for blood and air, local anesthetic will be deposited using single injection technique.

In Retroclavicular Approach, the probe will be placed below and perpendicular to the clavicle, in paramedian Sagittal plane, medial to coracoid process, to obtain the view of the cords of brachial plexus and axillary vessels. The needle will be inserted in the Supraclavicular fossa, posteriorly to the clavicle and advanced in plane and parallel to the ultrasound transducer.

Again, once the needle penetrates the brachial plexus sheath on ultrasound, after negative aspiration for blood and air, the local anesthetic mixture will be deposited using single injection technique.

Motor blockade will be assessed by using modified Bromage scaling

Grade 0 Normal motor function with full flexion and extension of joint of upper limb, namely the elbow, wrist and fingers.

Grade 1- will be identified when there is a decrease in motor strength with the patients able to move the fingers only.

Grade 2- will be considered when there will be complete motor block and the patients will be unable to move their fingers.

Sensory blockade will be evaluated using pinprick method using 23G Hypodermic 1,3,5,7,10 and every 5 min in radial, ulnar, median and musculocutaneous nerve territory.

Grading of sensory blockade will be taken as

Grade 0- Sharp pinprick sensed

Grade 1 Touch sensation on pinprick

Grade 2- Not even touch sensation.

Onset of sensory blockade will be time interval between complete administration of local anaesthetics to the loss of sensation in all 4 nerve territories, duration of sensory block is from complete sensory till NRS score reaches 4 or more. Duration of sensory block is the time from the injection of local anesthetic to the time the patient recovered full sensation of the upper limb. Onset of motor block is defined as from completion of drug injected till it reaches modified Bromage scale 2. Duration of motor block is the time from injection of local anesthetic to the time the patient recovers with full function of the arm. Needling time is the time interval between needle insertion through the skin wheal and the end of local anesthetic injection. Imaging time is the time interval between probe placement and needle insertion. Performance time is the sum of the imaging and needling time. Intraoperatively patient will be assessed pulse rate, SBP, DBP, SpO2 and RR were monitored every 5 minutes for first 30 minutes and then every 15 minutes till end of surgery. Any side effects such as Nausea, vomiting, hematoma, desaturation and respiratory distress will be seen and treated accordingly. Postoperatively patient will be assessed every 2nd hourly till NRS score reaches 4 or more at that time. Rescue analgesia Inj. Diclofenac 75mg will be given and time will be noted which will be considered as Rescue analgesia time.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor 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 ASA-Grade I and II.
  • Patients undergoing elective upperlimb surgeries.

排除标准

  • Patients refusal for the procedure.
  • Patients with history of allergy , sensitivity or any kind of reactions to local anesthetic agents.
  • Patient with bleeding disorders and any significant coagulopathies and other contra indications for regional anesthesia.
  • Infection of the skin at the injection site 5)Any lesion obscuring sonoanatomy.
  • Patients with pre-existing significant systemic diseases.
  • Patients on anticoagulants.
  • Patients with psychiatric illness.

结局指标

主要结局

Success Rate

时间窗: This will assessed after performing block by assessing motor and sensory Blockade

次要结局

  • Post operative Analgesia(Postoperative analgesia- Pain will be assessed)
  • Rescue Analgesia Requirement(This will be assessed in the postoperative period)
  • Paresthesia during block performance(This Will be noted while giving block)
  • Vascular puncture(This will noted while giving block)
  • Pleural Puncture(This will be Noted while giving block)

研究者

发起方
Spoorthi V
申办方类型
Other [[self}]
责任方
Principal Investigator
主要研究者

Spoorthi V

Navodaya Medical College, Hospital And Research Centre

研究点 (1)

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