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CTRI Number  CTRI/2024/03/064566 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 26/06/2024
Post Graduate Thesis  No 
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 (Levobupivacaine with dexmedetomidine and Ropivacaine with dexmedetomidine) for ultrasound guided supraclavicular nerve block (brachial plexus block): a randomised controlled trial. 
Scientific Title of Study   Comparison of Levobupivacaine and dexmedetomidine versus Ropivacaine and dexmedetomidine for ultrasound guided supraclavicular brachial plexus block: a randomised control 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  Sofia Batool 
Designation  Associate Professor 
Affiliation  Sikkim Manipal Institute of Medical Sciences 
Address  Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong. Gangtok.

East
SIKKIM
737102
India 
Phone  9733005809  
Fax    
Email  sofia.b@smims.smu.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Sofia Batool 
Designation  Associate Professor 
Affiliation  Sikkim Manipal Institute of Medical Sciences 
Address  Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong. Gangtok.


SIKKIM
737102
India 
Phone  9733005809  
Fax    
Email  sofia.b@smims.smu.edu.in  
 
Details of Contact Person
Public Query
 
Name  Sofia Batool 
Designation  Associate Professor 
Affiliation  Sikkim Manipal Institute of Medical Sciences 
Address  Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong. Gangtok.


SIKKIM
737102
India 
Phone  9733005809  
Fax    
Email  sofia.b@smims.smu.edu.in  
 
Source of Monetary or Material Support  
Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok. 
 
Primary Sponsor  
Name  Dr Sofia Batool 
Address  Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences. 5th Mile, Tadong. Gangtok. 737102. 
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 
Dr Sofia Batool  Sikkim Manipal Institute of Medical Sciences  5th Mile, Tadong. Gangtok. 737102.
East
SIKKIM 
9733005809

sofia.b@smims.smu.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SMIMS Institution Ethics 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 
Intervention  Levobupivacaine with Dexmedetomidine  24 ml solution of 0.5% Levobupivacaine and 50 mcg of Dexmedetomidine will be used to block brachial plexus in supraclavicular region under ultrasound guidance  
Comparator Agent  Ropivacaine with Dexmedetomidine  24 ml solution of 0.5% Ropivacaine and 50 mcg of Dexmedetomidine will be used to block brachial plexus in supraclavicular region under ultrasound guidance 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. American society of Anaesthesiology (ASA) grade I and II
2. Elective upper limb surgery lasting more than 30 minutes 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Onset and duration of sensory and motor block
2. Numerical Rating Scale (NRS) for post-operative analgesia 
1. For onset and duration of block: every 5 minutes for 30 minutes
2. For Numeric rating scale: every hour following surgery till the request of first analgesic 
 
Secondary Outcome  
Outcome  TimePoints 
1. Ramsay sedation score
2. Hemodynamic parameters (pulse rate, blood pressure, oxygen saturation of blood) 
Every 5 minutes till the end of surgery 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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)   01/04/2024 
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="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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   Background
Supraclavicular brachial plexus block is popular and widely used nerve block technique for anaesthesia and analgesia for upper limb surgeries. Lidocaine and bupivacaine are most often used local anaesthetic agents. Newer drugs are safe and have less systemic side effects. The purpose of the present study is to to find a local anaesthetic agent with maximum efficacy and minimum side effects for upper extremity blocks.

Research Question
Is Levobupivacaine with dexmedetomidine better than Ropivacaine with dexmedetomidine for peripheral nerve blocks?

Objectives
Primary objectives
1. To compare the onset and duration of sensory and motor block between levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine
2. To compare post operative analgesia between levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine
Secondary objectives
1. To compare the Ramsay sedation score between the two groups
2. To compare the hemodynamic parameters between two groups

Hypothesis
Null hypothesis (H0): There is no difference between the two drugs (levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine) for onset of action, duration of action and postoperative analgesia.
Alternate hypothesis (H1): Levobupivacaine with dexmedetomidine is better than ropivacaine with dexmedetomidine for onset of action, duration of action and postoperative analgesia.

Methodology
Inclusion criteria
1. American society of Anaesthesiology Grade (ASA) - I, II
2. Age between 18 years and 65 years
3. Elective upper limb surgery lasting more than 30 mins
Exclusion criteria
1. Uncontrolled hypertension, diabetes mellitus, arrhythmias, 
2. Heart failure, renal failure, liver failure
3. Seizure disorder
4. Bleeding/ coagulation disorder
5. Pre-existing peripheral neuropathy
6. Known hypersensitivity to local anaesthetics.
7. BMI >30
8. Local skin infection
9. Pregnancy and lactating mothers
10. Bradycardia (heart rate <50 /min)
Procedure standardization
Patients will be randomized using simple lottery (sealed envelope) technique. Once patients received in preoperative area, patients will be divided into two groups; Group L and Group R based on envelope selected by them. Envelopes would contain drug details and dosage to be prepared by OT technicians. 
The drugs will be prepared as follows:
Group L: Levobupivacaine 0.5% (24 ml) with dexmedetomidine 50 mcg (1 ml)
Group R: Ropivacaine 0.5% (24 ml) with dexmedetomidine 50 mcg (1 ml)
Total volume of the drug will be 25ml for all patients.
Patient will be taken to the operation theatre; vitals will be monitored, and supraclavicular block performed under all aseptic precautions under ultrasound guidance by an anaesthesiologist who will be unaware of the drug composition. Once the study drug is delivered, following parameters will be assessed and noted.
1. Time of onset of sensory and motor block
2. Time when complete sensory and motor block is achieved
After achieving complete sensory and motor block patient is proceeded for surgery. Only successful block cases will be taken for study. Throughout intraoperative period vitals are monitored .Degree of sedation will be monitored at all intervals as that of vital parameters. On arrival in the postanaesthetic care unit, pain scoring will be assessed using Numeric Rating Scale (NRS) on movement of operated arm. NRS on movement will be assessed hourly following surgery till the request of first analgesic. Postoperative vitals will be assessed every hour till the regression of block. Any side effects such as nausea, vomiting, and sedation will be noted. Postoperative sedation score will be assessed hourly till the regression of block.
Data analysis
The data will be tabulated and analysed using Microsoft© Excel© 2013 and IBM© SPSS©-21 software. The categorical data will be analysed using χ2 and Fisher Exact test and continuous data using student t-test and ANOVA. 
 
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