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CTRI Number  CTRI/2024/05/067091 [Registered on: 09/05/2024] Trial Registered Prospectively
Last Modified On: 07/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of effects of two different drugs(Bupivacaine and Ropivacaine) of equal doses in nerve block with patients undergoing elective hand surgeries and its impacts on the lung function by Spirometer  
Scientific Title of Study   Evaluation of the effects of Ultrasound guided Supraclavicular brachial plexus block with 0.5% Bupivacaine versus 0.5% Ropivacaine in equal doses on Pulmonary function test in patients undergoing elective upper limb surgeries - A Randomised Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Senthilkumaran 
Designation  Post Graduate 
Affiliation  Pondicherry Institute of Medical Science 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences Campus, Kalapet Pondicherry.

Pondicherry
PONDICHERRY
605014
India 
Phone  6379257503  
Fax    
Email  senthilkumarana97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. MV Vidya 
Designation  Associate Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences Campus, Kalapet Pondicherry.

Pondicherry
PONDICHERRY
605014
India 
Phone  9585550838  
Fax    
Email  drmvvidya@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Senthilkumaran 
Designation  Post graduate 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology, Pondicherry Institute of Medical Sciences Campus, Kalapet Pondicherry.

Pondicherry
PONDICHERRY
605014
India 
Phone  6379257503  
Fax    
Email  senthilkumarana97@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute of Medical Sciences Campus, Kalapet ,Pondicherry-605014, India 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Science 
Address  Pondicherry Institute of Medical Sciences campus,Ganapathichettikulam, kalapet, Puducherry - 605014 
Type of Sponsor  Private medical college 
 
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 
Dr Senthilkumaran  Pondicherry Institute of Medical Sciences  Department of Anaesthesiology, Kalapet Pondicherry 605014
Pondicherry
PONDICHERRY 
6379257503

senthilkumarana97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S610||Open wound of thumb without damageto nail,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.5% bupivacine  Patient will be administered 20 ml of 0.5% bupivacine in supra clavicular brachial plexus block which will be deposited around the nerve once using Ultrasound. The total duration of the procedure will be around 30 minutes  
Intervention  0.5% ropivacine  Patient will be administered 20 ml of 0.5% ropivacine in supra clavicular brachial plexus block which will be deposited around the nerves once using ultrasound. the duration of the procedure will be around 30 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Elective Upper limb surgeries including the elbow, forearm and hand
2) Age 18–65 years
3) Body mass index (BMI) 18–30 kg/m2
4) American Society of Anesthesiologists (ASA) score I or II
 
 
ExclusionCriteria 
Details  1) Arrhythmia.
2) Respiratory system disease, trauma to chest wall, spine deformities like scoliosis
3) Known case of diaphragmatic paralysis
4) Upper limb sensory or movement disorder.
5) Coagulopathy
6) Known allergy to drugs
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the effects of ultrasound guided supraclavicular block of brachial plexus block with 0.5% ropivacaine and 0.5% bupivacaine in equal doses on pulmonary function test using Spirometer  The Pulmonary function test will be performed at Preoperatively(Baseline), 15 minutes and 30minutes after the Supraclavicular brachial plexus block and at 3rd and 6 th hour post operatively 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the sensory and motor blockade characteristics between the two drugs  The sensory blockade will be assessed every 2 minutes for the first 15minutes and every 5 minutes till next 15minutes. The motor block will be assessed every 5 minutes till 30 minutes. The patient will be shifted to the Operation theatre after 30minutes and will be connected to the standard ASA monitor. 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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   Phase 4 
Date of First Enrollment (India)   29/05/2024 
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="11"
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  
This is a prospective study where after Pre Anaesthetic Checkup the patients will be shifted to the operation theatre complex on call and pre anaesthetic review will be done to check if pre operative orders were followed. Then the patient will be shifted to Pre operative holding area and connected to monitors like pulse oximeter, ECG, non-invasive blood pressure and the baseline hemodynamic parameters and will be recorded.18G IV cannula will be secured on the opposite hand and intravenous fluid Ringer Lactate will be started at 6ml/kg prior to supraclavicular block. The patient in semi recumbent position will be asked to blow after taking a deep breath through the filter mouth piece of the spirometer (Safey Pocket Spirometer, India. Product code no: 1652213) 3 times at 2 minutes gap which will be linked to the Mobile phone using bluetooth. The FVC, FEV1 and PEFR will be recorded and the average (best of the 3 values) of the values will be recorded as the pre block PFT. Ultrasound-guided brachial plexus block will be performed prior to surgery in the pre-operative holding area by an attending anaesthesiologist with formal regional anaesthesia training
The patient will be positioned in supine and the hand will be rested following which the Supraclavicular block with ultrasound guidance will be proceeded. For the procedure, patient will be positioned supine with a small roll beneath the shoulder and head turned to the contralateral side to surgical side. Ultrasonography machine with linear probe (6-14 MHz) will be used. The arm to be blocked will be kept adducted and the hand will be rested over the abdomen. Under strict aseptic precaution, transducer
12
will be positioned in the transverse plane immediately proximal to the clavicle, and tilted caudally to obtain cross sectional view of subclavian artery.
The brachial plexus will appear as hypoechoic shadows surrounded by hyperechoic rims, lateral to subclavian artery placed above the first rib, classically described as honeycomb appearance. The subclavian artery is appreciated as pulsatile anechoic structure above first rib. The rib is a hyperechoic structure and it generates a bony shadow while the lung is a specular reflector and therefore a grainy image will be seen below the hyperechoic edge of pleura. Colour doppler can be used to distinguish between vascular and nerve structure.
Needle insertion will be done in Double point injection technique. The 18 G venflon needle will be inserted 1-2 cm lateral to probe using in-plane technique toward plexus from lateral to medial direction. Hydro dissection with 0.5-1 ml of normal saline will be done to increase the acoustic mismatch and for better visualization of needle tip. As the needle reaches the “corner pocket”, formed between the subclavian artery medially and first rib inferiorly. i.e., at 7 o’clock position with respect to subclavian artery, 10 ml of drug volume will be injected following repeated aspirations, then the needle will be slowly withdrawn and directed towards the superolateral aspect of the subclavian artery and remaining 10 ml drug will be injected.
Group A will be given 20 ml of 0.5% Bupivacaine whereas Group B will be given 20ml of 0.5% Ropivacaine.
Post procedure the patient will be asked blow through the spirometer and the PFT will be repeated as mentioned before at 15 minutes, 30 minutes, 4 hours and 6 hours. The sensory blockade will be assessed every 2 minutes for the first 15minutes and every 5 minutes till next 15minutes. The motor block will be assessed every 5 minutes till 30 minutes. The patient will be shifted to the Operation theatre after 30minutes and will be connected to the standard ASA monitor. The sensory blockade will be assessed by the Pin Prick Test with 3point score
The motor blockade will be assessed by the Modified Bromage Scale 
During the course of intraoperative time, the Heart rate, SBP, DBP, Oxygen saturation and respiratory rate will be recorded for every 5 minutes for the first 30 minutes and every 30 minutes thereafter till the procedure gets over.
The Hypothesis is that In ultrasound guided supraclavicular brachial plexus block, 0.5% ropivacaine is better than 0.5% bupivacaine in preserving the pulmonary function in patients undergoing elective upper limb surgeries
 
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