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CTRI Number  CTRI/2024/12/077922 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 27/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two different techniques to numb the upper limb during upper limb surgeries using Ultrasound 
Scientific Title of Study   Ultrasound guided Retroclavicular vs Supraclavicular brachial plexus block in upper limb surgery: A Randomized comparative study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Spoorthi V 
Designation  first year post graduate student 
Affiliation  Navodaya Medical College, Hospital And Research Centre  
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9916394761  
Fax    
Email  spoorthiv43@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devanand B 
Designation  Professor 
Affiliation  Navodaya Medical College, Hospital And Research Centre  
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9845233239  
Fax    
Email  dr.devanand.b@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Devanand B 
Designation  Professor 
Affiliation  Navodaya Medical College, Hospital And Research Centre  
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9845233239  
Fax    
Email  dr.devanand.b@gmail.com  
 
Source of Monetary or Material Support  
Navodaya Medical College , Hospital And Research Centre, Raichur 584103 
 
Primary Sponsor  
Name  Spoorthi V 
Address  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka 
Type of Sponsor  Other [[self}] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Spoorthi V  Navodaya Medical College , Hospital and Research Centre  Department of Anesthesiology Navodaya Medical College, Hospital And Research Centre Raichur- 584103 Karnataka
Raichur
KARNATAKA 
9916394761

spoorthiv43@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE (IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S42||Fracture of shoulder and upper arm, (2) ICD-10 Condition: S599||Unspecified injury of elbow and forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Retroclavicular Brachial Plexus Block  Retroclavicular Brachial Plexus Block with 20 ml of 0.5% Ropivacaine will be given under USG Guidance 
Comparator Agent  Supraclavicular Brachial Plexus Block  Supraclavicular Brachial Plexus Block with 20 ml 0.5% Ropivacaine will be given under USG Guidance 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Patients belonging to ASA-Grade I and II.
2) Patients undergoing elective upperlimb surgeries 
 
ExclusionCriteria 
Details  1)Patients refusal for the procedure.
2)Patients with history of allergy , sensitivity or any kind of reactions to local anesthetic agents.
3)Patient with bleeding disorders and any significant coagulopathies and other contra
indications for regional anesthesia.
4)Infection of the skin at the injection site
5)Any lesion obscuring sonoanatomy.
6) Patients with pre-existing significant systemic diseases.
7)Patients on anticoagulants.
8)Patients with psychiatric illness 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Success Rate  This will assessed after performing block by assessing motor and sensory Blockade 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative Analgesia  Postoperative analgesia- Pain will be assessed
using pain score: Numerical Rating Scale at 2nd,
4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 20th,
22nd and 24th hour postoperatively. 
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 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary    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.
 
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