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CTRI Number  CTRI/2022/11/047461 [Registered on: 21/11/2022] Trial Registered Prospectively
Last Modified On: 18/11/2022
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 drugs in brachial plexus block for upper limb surgeries 
Scientific Title of Study   Comparison of two doses of dexmedetomidine as adjuvent to 0.5% Ropivacaine in ultrasound guided brachial plexus block in upper limb surgeries-A Randomised Control Trail 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Malti Agrawal 
Designation  Professor and HOD 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL  
Address  Room no 2062 B Anaesthesia Department Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9897897050  
Fax    
Email  dr_malti_agrawal@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Malti Agrawal 
Designation  Professor and HOD 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL  
Address  Room no 2062 B Anaesthesia Department Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9897897050  
Fax    
Email  dr_malti_agrawal@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pradeep Kumar 
Designation  JUNIOR RESIDENT 
Affiliation  ROHILKHAND MEDICAL COLLEGE AND HOSPITAL  
Address  Room No 45 PG Boys Hostel Rohilkhand Medical College and Hospital Pilibhit Bypass Road Bareilly 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  9860980503  
Fax    
Email  kumaar.pradeep97@gmail.com  
 
Source of Monetary or Material Support  
Rohilkhand Medical College And Hospital  
 
Primary Sponsor  
Name  Rohilkhand Medical College and Hospital  
Address  Rohilkhand Medical College and Hospital Pilibhit Bypass Road BAREILLY 243006 
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 Malti Agrawal  Openration Theatre Rohilkhand Medical College And Hospital  Department Of Anaesthesiology Rohilkhand Medical College Bareilly UTTAR PRADESH
Bareilly
UTTAR PRADESH 
9897897050

dr_malti_agrawal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional 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  Brachial plexus block with ropivacaine and dexmedetomidine  0.5 % Ropivacaine with 30 micrograms dexmedetomidine in brachial plexus block 
Comparator Agent  Brachial plexus block with ropivacaine and dexmedetomidine  0.5% Ropivacaine with 50 micrograms dexmedetomidine in brachial plexus block  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  American society of Anesthesiologist (ASA) grade I or II

Posted for surgery of upper limb under ultrasound guided brachial plexus block.
 
 
ExclusionCriteria 
Details  Refusal by patient

Patients taking anticoagulants, β- blockers or opioids, psychotropic medication.

Patients with history of significant​neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease.

Patients having history of drug and alcohol abuse.

Patients with contraindication to Ropivacaine and dexmedetomidine.

Women with pregnancy or lactating women.

Patients on chronic analgesic therapy, diabetes or having coagulation disorders.

Patient with infection at site of injection. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Onset of sensory block and duration of sensory block

Onset of motor block and duration of motor block

Duration of postoperative analgesia 
The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic responses to the drug during and after surgery.

Any complication or side effects. 
At 2,4,6,8,10,12,14,16,18,20,30,40,50, 60, 90, 120,180,240,360,480,720 minutes after

the block, the ECG II lead, heart rate, systolic, diastolic, and mean blood pressure, and oxygen saturation will be recorded.
 
 
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   N/A 
Date of First Enrollment (India)   24/11/2022 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

In today’s world brachial plexus block has evolved as an important part of dailyroutine anaesthesiology practice as an substitute to general anaesthesia for upper limb surgeries. This mode of anaesthesia is also considered safe due to its application with an ultrasound guided live imaging. Also, it aids patient in form of providing post operative analgesia and reducing hospital stay that helps patient financially also.

The first supraclavicular block was performed in 1912 by kulen kampff byconventional parasthesia technique blind technique. Giving regional anaesthesia by blind technique has an high failure risk and risk of damaging vital anatomical structures. Ultrasound guided regional anaesthesia eliminates this drawback of blind technique.2 In 1978 La Grange introduced application of doppler probe to identify arteries .

In regional anaesthesia we use a local anaesthesia that is used to block the brachialplexus. These local anaesthetics have limited duration of action and providing post operativeanalgesia. Ropivacaine being a long acting amino amide is one of foremost drug used inbrachial plexus block. Ropivacaine when compared with bupivacaine and levobupivacainehas lower lipid solubility and hence provide greater sensory and motor blockade duration and also motor function recovery is fast.

Ropivacaine when compared with other local anaesthetic like bupivacaine and levobupivacaine is less cardiac and central nervous system toxic drug. It acts on voltage gatedsodium channels that blocks peripheral afferents.

Even with use of Ropivacaine it was found that duration of analgesia was limited andpatients complained of post operative pain and opiod administration was required to prolongpost operative analgesia duration. So use of adjuvents with  local anaesthetic came into existence such as dexmedetomidine, clonidine, opioids and neostigmine. These helped toprolong post operative analgesia. Opioids are known to cause various side effects like apnea,respiratory suppression, hypoxia so dexmedetomidine provides anaesthesiologists with abetter alternative to opoids and helps to elinminates these side effets.

Dexmedetomidine is an alpha 2 receptor blocker agonist that can be used as anadjuvent to local anaesthetic in order to prolong duration of post operative analgesia and to decrease time of onset . Dexmedetomidine has analgesic, sedative antihypertensive and anaesthetic sparing properties that contributes multimodaly. Dexmedetomidine as alpha 2agonist is highly selective (more than 8 times selective as compared to clonidine ) as an adjuvant.

Previous studies are present that have compared various local anaesthetics alone andwith combination with adjuvents in brachial plexus blocks for upper limb surgeriesindividually. To our comprehension few study are known to have compared effects ofropivacaine in regional anaesthesia in brachial plexus block in combination with two differentdosages of dexmedetomidine, and access results of these two groups.

 
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