FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/09/036773 [Registered on: 23/09/2021] Trial Registered Prospectively
Last Modified On: 21/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   COMPARISON OF TWO LOCAL ANAESTHETIC DRUGS (ROPIVACAINE AND LEVOBUPIVACAINE) FOR NERVE BLOCK IN PATIENTS UNDERGOING UPPER LIMB SURGERY 
Scientific Title of Study   COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE FOR ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Karthiga Manoharan 
Designation  Post Graduate 
Affiliation  ABVIMS AND DR.RML HOSPITAL 
Address  Department of Anaesthesia ABVIMS and DR.RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  9677556650  
Fax    
Email  karthiga96.mano@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR VINOD BALA DHIR 
Designation  PROFESSOR 
Affiliation  ABVIMS AND DR.RML HOSPITAL 
Address  Department of Anaesthesia ABVIMS and DR.RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  9868223931  
Fax    
Email  drvinoddhir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Karthiga Manoharan 
Designation  Post Graduate 
Affiliation  ABVIMS AND DR.RML HOSPITAL 
Address  Department of Anaesthesia ABVIMS and DR.RML Hospital, New Delhi

New Delhi
DELHI
110001
India 
Phone  9677556650  
Fax    
Email  karthiga96.mano@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology A.B.V.I.M.S AND DR.RML HOSPITAL 
 
Primary Sponsor  
Name  ABVIMS AND DRRML HOSPITAL 
Address  Doctors hostel, DR.RML Hospital, New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
ABVIMS AND DRRML HOSPITAL  DR.RML Hospital, New Delhi 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR KARTHIGA  A.B.V.I.M.S AND DR.RML HOSPITAL  Department of Anaesthesia ABVIMS and DR.RML Hospital, New Delhi
New Delhi
DELHI 
9677556650

karthiga96.mano@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ABVIMS AND DR.RML HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE  COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE FOR ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY Group 1 – Patients will receive 30 ml of 0.5% ropivacaine with 25 µg Fentanyl Group 2 – Patients will receive 30 ml of 0.5% levobupivacaine with 25 µg Fentanyl Observations 1. Onset of Sensory and motor block 2. Duration of Sensory and motor block will be assessed every hour till the recovery 3. Heart rate, SBP, DBP, MAP, SpO2 will be recorded every 5 mins for the first 15 mins and thereafter every 15 mins throughout the surgery  
Intervention  ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY  COMPARISON OF ROPIVACAINE AND LEVOBUPIVACAINE FOR ULTRASOUND GUIDED BRACHIAL PLEXUS BLOCK IN ADULT PATIENTS UNDERGOING UPPER LIMB SURGERY SUPRA-CLAVICULAR BRACHIAL PLEXUS BLOCK Position: This block will be performed with the patient in the supine position, with the patient’s head turned away from the side to be blocked. USG guided Technique: After sterile preparation and draping, the transducer is positioned in the transverse plane immediately proximal to the clavicle, slightly posterior to at its midpoint. The transducer is tilted caudally, as if to image the chest contents, to obtain a cross-sectional view of the subclavian artery. The brachial plexus is seen as a collection of hypoechoic oval structures posterior and superficial to the artery. Colour Doppler should be routinely used prior to needle insertion to rule out the passage of large vessels (i.e., dorsal scapular artery, transverse cervical artery, suprascapular artery) in the anticipated trajectory of the needle. Using a 25-gauge needle, 1–2 mL of local anesthetic is injected into the skin 1 cm lateral to the transducer to decrease discomfort during needle insertion. The block needle is then inserted in plane toward the brachial plexus, in a lateral-to-medial direction. After careful aspiration, 1–2 mL of normal saline is injected to confirm proper needle placement. When the injection displaces the brachial plexus away from the needle, an additional advancement of the needle 1–2 mm closer to the plexus may be required to accomplish adequate local anesthetic spread.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age 18-65 years
2. ASA Grade I & II
3. Patients scheduled for upper limb orthopedic surgeries 
 
ExclusionCriteria 
Details  1. Patients with infection at the site of injection.
2. Patients with known history of allergy to any of the study medications .
3. Patients with bleeding disorders and those on anti-coagulant therapy.
4. Patients with neurological disorders and neuropathy.
5. Failure of block (in these patients, general anaesthesia will be supplemented). 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the duration of sensory and motor blockade of ropivacaine and levobupivacaine in
Ultrasound guided supra-clavicular brachial plexus block for upper limb surgeries. 
Time of giving supraclavicular brachial plexus block is taken as baseline (0 minutes). Patient is monitored every 15 mins in the intraoperative period followed by every 1 hour in the postoperative period upto 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
To study the hemodynamic profile (HR, SBP, DBP, MAP, SPO2) in both the groups  HR, SBP, DBP, MAP, SPO2 will be monitored every 2 hours for the first 6 hours and thereafter
every 4 hours till the need for rescue analgesia.
 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   30/09/2021 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   AIM: To compare the duration of sensory and motor blockade with Ropivacaine and Levobupivacaine in Ultrasound guided Supraclavicular brachial plexus block for upper limb surgeries. 

PRIMARY OBJECTIVE: To study the duration of sensory and motor blockade of ropivacaine and levobupivacaine in Ultrasound guided supra-clavicular brachial plexus block for upper limb surgeries. 

SECONDARY OBJECTIVE: To study the hemodynamic profile (HR, SBP, DBP, MAP, SPO2) in both the groups.

METHODOLOGY 
   After a detailed pre-anaesthetic check-up, an informed consent will be obtained from all the patients after explaining the details of the procedure. In the operation theatre, pre-operative parameters including heart rate (HR), Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Mean Arterial Pressure (MAP) and oxygen saturation (SpO2) will be recorded and an intravenous access established and iv fluids started. Patients will be sedated with intravenous Midazolam 0.03 mg/kg, supra-clavicular brachial plexus block will then be performed . 

SUPRA-CLAVICULAR BRACHIAL PLEXUS BLOCK

Position: This block will be performed with the patient in the supine position, with the patient’s head turned away from the side to be blocked.

USG guided Technique: After sterile preparation and draping, the transducer is positioned in the transverse plane immediately proximal to the clavicle, slightly posterior to at its midpoint. The transducer is tilted caudally, as if to image the chest contents, to obtain a cross-sectional view of the subclavian artery. The brachial plexus is seen as a collection of hypoechoic oval structures posterior and superficial to the artery. Colour Doppler should be routinely used prior to needle insertion to rule out the passage of large vessels (i.e., dorsal scapular artery, transverse cervical artery, suprascapular artery) in the anticipated trajectory of the needle. Using a 25-gauge needle, 1–2 mL of local anesthetic is injected into the skin 1 cm lateral to the transducer to decrease discomfort during needle insertion. The block needle is then inserted in plane toward the brachial plexus, in a lateral-to-medial direction. After careful aspiration, 1–2 mL of normal saline is injected to confirm proper needle placement. When the injection displaces the brachial plexus away from the needle, an additional advancement of the needle 1–2 mm closer to the plexus may be required to accomplish adequate local anesthetic spread. 

 After proper needle placement: 
Group 1 – Patients will receive 30 ml of 0.5% ropivacaine with 25 µg Fentanyl (n=21) 
Group 2 – Patients will receive 30 ml of 0.5% levobupivacaine with 25 µg Fentanyl (n=21) Surgical anaesthesia will be achieved when the patient shows complete loss of sensation in the surgical field with the concomitant inability to elevate the operated limb.

OBSERVATION: The following observations will be made: 
• Time of onset of sensory block : the time from the completion of the injection of drug till the patient can no longer feel the cold sensation in the surgical field by the Ice test method. 
• Time of onset of motor block : the time from the completion of the injection of drug till the complete block i.e. Modified Bromage scale of 3. 
• ECG and SpO2 will be monitored continuously throughout the surgery. 
• HR, SBP, DBP, MAP will be recorded every 5 mins for the first 15 mins and thereafter every 15 mins throughout the surgery. 
• Duration of sensory and motor blockade will be assessed every hour till the recovery. 
• Duration of sensory block will be defined as time from the loss of temperature sensation till the recovery of sensation (by Ice test method). 
• Duration of motor blockade will be defined as the time when Modified Bromage scale of 3 is achieved till the time of achievement of Modified Bromage scale of 2. 
• HR, SBP, DBP, MAP, SPO2 will be monitored every 2 hours for the first 6 hours and thereafter every 4 hours till the need for rescue analgesia. 
• After the recovery of sensations, pain will be assessed using Visual Analogue Scale (VAS score 0= no pain to 10=worst pain) every hour till the need for rescue analgesia. Rescue analgesia will be administered at a VAS of ≥4.
 
Close