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CTRI Number  CTRI/2024/02/063071 [Registered on: 23/02/2024] Trial Registered Prospectively
Last Modified On: 21/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of bupivacaine and levobupivacaine with adjuvant buprenorphine in brachial plexus block in upper limb surgeries 
Scientific Title of Study   Comparative study of bupivacaine and levobupivacaine with adjuvant buprenorphine in ultrasound guided supraclavicular brachial plexus block in upper limb surgeries 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Angeline Suma Davis 
Designation  Junior Resident 
Affiliation  JSS Academy of Higher Education and Research 
Address  Department of Anaesthesiology, JSS hospital Mahatma Gandhi road, Fort Mohalla, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  7218272526  
Fax    
Email  angelinedavis97@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Manjula BP 
Designation  Professor 
Affiliation  JSS Academy of Higher Education and Research 
Address  Department of Anaesthesiology, JSS hospital Mahatma Gandhi road, Fort Mohalla, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9845501226  
Fax    
Email  bpmanjula5@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Manjula BP 
Designation  Professor 
Affiliation  JSS Academy of Higher Education and Research 
Address  Department of Anaesthesiology, JSS hospital Mahatma Gandhi road, Fort Mohalla, Mysuru

Mysore
KARNATAKA
570004
India 
Phone  9845501226  
Fax    
Email  bpmanjula5@gmail.com  
 
Source of Monetary or Material Support  
JSS Medical college and Hospital, Mahatma Gandhi road, Fort Mohalla, Mysuru, Karnataka 570004 
 
Primary Sponsor  
Name  JSS Academy of Higher Education and Research  
Address  JSS Medical college and Hospital  
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 Angeline Suma Davis  JSS medical college and hospital  Patients of orthopedics , plastic surgery, general surgery undergoing elective upper limb surgeries under supraclavicular brachial plexus block, 3rd floor OT complex, MG road, Agrahara, Mysuru, Karnataka, 570004
Mysore
KARNATAKA 
7218272526

angelinedavis97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JSS medical college and hospital Institutional ethical committee  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  Inj levobupivacaine, inj buprenorphine  30ml of 0.5%inj levobupivacaine (150mg) and inj. Buprenorphine 150 mcg is injected with an 10ml syringe at the brachial plexus after identifying the brachial plexus under ultrasound guidance through supraclavicular approach before the start of the surgical procedure. If block fails to act the procedure will be abandoned and converted to general anesthesia, which will not be included in the trail. After giving the block the onset and total duration of sensory and motor block will be assessed, post operative pain will be assessed, time for 1st rescue analgesic and total analgesic requirement will be assessed 
Intervention  Inj.bupivacaine , inj buprenorphine  30ml of 0.5%inj bupivacaine (150mg) and inj. Buprenorphine 150 mcg is injected with an 10ml syringe at the brachial plexus after identifying the brachial plexus under ultrasound guidance through supraclavicular approach before the start of the surgical procedure. If block fails to act the procedure will be abandoned and converted to general anesthesia, which will not be included in the trail. After giving the block , the onset and total duration of sensory and motor block will be assessed, post operative pain will be assessed, time for 1st rescue analgesic and total analgesic requirement will be assessed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  - Age between 18 years-60 years
- ASA-PS I and II
- Posted for upper limb surgeries 
 
ExclusionCriteria 
Details  -Patient not giving consent
-Coagulopathy
-Neuropathy
-Pregnancy
-Hemodynamic instability
-Allergic history to local anesthetic
-Local infection, open wound , distorted anatomy in the affected side of neck and supraclavicular area due to hematoma, swelling
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the effect of block and duration of analgesia by adding adjuvant buprenorphine to bupivacaine and levobupivacaine   From giving supraclavicular brachial plexus block to 24 hours postoperative period 
 
Secondary Outcome  
Outcome  TimePoints 
To determine onset and duration of sensory block using Holmen scale, to determine onset and duration of motor block using modified bromage scale, to determine total duration of postoperative analgesia using VAS score, any side effects like nausea, vomiting, pruritis, respiratory depression   From giving supraclavicular brachial plexus block to 24 hours postoperative period 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/03/2024 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

 Informed and written consent will be taken from 60 patients satisfying the inclusion criteria who will be undergoing upper limb surgery in JSS hospital, Mysuru.

A thorough preanesthetic evaluation will be done 24 hours prior to the procedure.

Standard preanaesthetic advice of fasting will be given to the patient. The patients were informed about the procedure and its potential consequences. All the patients were taught how to use the visual analog scale system. Standard preanesthetic advice of fasting will be given to the patient. Randomization will be done by the sequentially numbered, opaque, sealed envelope (SNOSE) technique by experienced anesthesiologist performing the block. The enrolled 60 patients based on randomization will be divided into two groups.

Group BB – 30 patients will receive 30ml of 0.5% bupivacaine with 150 mcg of buprenorphine

Group LB –30 patients will receive 30ml of 0.5% levobupivacaine with 150mcg of buprenorphine

On the day of the procedure, PAE will be reviewed and any fresh clinical history or signs along with relevant investigations will be noted. Fasting status and the site of surgery will be confirmed. After shifting to operation theatre, necessary monitors like electrocardiogram (ECG), pulse rate, oxygen saturation, blood pressure, respiratory rate will be connected and basal parameters noted.  An intravenous (IV) cannula will be inserted in the adjacent nonoperative arm and IV infusion of Ringer’s Lactate will be started. Premedication will be done with IV midazolam 0.03-0.04g/kg was given and oxygen will be administered at 4L/min through a Hudson’s mask. Ultrasound (placed on the opposite side of the block) with linear probe, a pre block scan will be done to assess the anatomy and location of the nerves and its relation to the vessels with the use of color Doppler

Under aseptic precautions, area of injection is cleaned with antiseptic solution and ultrasound probe is covered with sterile wrap. Patient will be in supine position and head is turned to the opposite side of the block. The head of the bed may be elevated about 30 degrees. A towel roll may be needed under ipsilateral shoulder to improve access to supraclavicular space. The anesthesiologist performing the block will be positioned comfortably on the same side as the block. After applying sufficient jelly on the US probe, it is placed on the supraclavicular fossa in the transverse orientation parallel to the clavicle and aimed inferior to the ipsilateral thorax to identify the subclavian artery and the lateral location of the supraclavicular portion of the brachial plexus. Local infiltration is done with 2-3ml of 2% lignocaine at the injection site. In plane approach of needle placement is used to locate and all drug depositions are done under direction vision of the needle after confirming negative for aspiration of blood. In group I, 30 ml of 0.5% bupivacaine+ 150mcg buprenorphine is injected all around the plexus. In group II 30ml of 0.5% levobupivacaine + 150 mcg buprenorphine is injected into the supraclavicular nerve region. Block failure is described as the need for rescue analgesia i.e. sedative doses of fentanyl or other analgesics or conversion to general anesthesia. 

For the first 30minutes, vital indicators (pulse rate, blood pressure, respiratory rate) will be measured every 5 minutes, then every 15 minutes till the end of operation, until the patient complained of pain corresponding to a VAS score of 4. The onset of sensory and motor blockade, the duration of sensory and motor block and duration of postoperative analgesia, time to first rescue analgesic will be recorded. Sensory block will be measured by loss of feeling to pinprick sensation over the C5-T1 dermatomes using Hollmen Scale as:

1. Normal sensation of pinprick
2. Pinprick felt as sharp pointed but weaker compared with same area in the other upper limb
3. Pinprick recognized has touch with blunt object
4. No perception of pinprick

The onset time of sensory block will be taken has the time interval in minutes from injection of the local anesthetic till a Hollmen score of 2, while the time for complete sensory block will be taken till a Hollmen score of 4. The total duration of sensory block will be taken as the duration of time in minutes from the time of complete sensory block till the time Hollmen score of less than 4 was reached.

Motor block will be assessed using a modified Bromage Score for upper extremity:

1. Normal motor function with full flexion and extension of elbow, wrist and fingers
2. Decreased motor strength with ability to move the fingers only
3. Complete motor block with inability to move the fingers
4. Unable to move the arm, elbow or fingers 

Onset of motor block will be considered has the time interval in minutes from injection of the local anesthetic till when there was Grade-4 motor block. The total duration of motor block will be taken as the duration of time in minutes between the time to complete motor block till normal motor function (Grade 1). Pain will be assessed using VAS in which a score of 0 indicates no pain and a score of 10 indicates worst pain. The VAS measurements will be obtained at 2,4,6,12 hours post operatively. Rescue analgesic will be given at VAS score of 4. Time to first rescue analgesic and total analgesic given to each patient during first 24 hours’ post-operative period will be recorded. The occurrence of adverse effect like hypotension, nausea and vomiting will also be recorded  

 
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