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CTRI Number  CTRI/2024/07/070502 [Registered on: 12/07/2024] Trial Registered Prospectively
Last Modified On: 10/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study between Clonidine and Buprenorphine as adjuvants Ropivacaine in Ultrasound guided Infraclavicular Brachial Plexus Block 
Scientific Title of Study   A comparative study between Clonidine and Buprenorphine as adjuvants to 0.5 percent Ropivacaine in Ultrasound guided Infraclavicular Brachial Plexus Block 
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. Pramathesh A 
Designation  post graduate student 
Affiliation  Department of Anaesthesiology 
Address  Vydehi Institute of Medical Sciences and Research Centre, whitefield, Bangalore

Bangalore
KARNATAKA
560066
India 
Phone  7760498220  
Fax    
Email  pramathesh.a@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Shishir KR 
Designation  Associate professor 
Affiliation  Department of Anaesthesiology 
Address  Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore

Bangalore
KARNATAKA
560066
India 
Phone    
Fax    
Email  shishirsmashes@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Pramathesh A 
Designation  Junior Resident 
Affiliation  Department of Anaesthesiology 
Address  Vydehi Institute of Medical Sciences and Research Centre, Whitefield, Bangalore

Bangalore
KARNATAKA
560066
India 
Phone  7760498220  
Fax    
Email  pramathesh.a@gmail.com  
 
Source of Monetary or Material Support  
Vydehi Institute of Medical Sciences and Research Center, Whitefield, Bangalore-560066 
 
Primary Sponsor  
Name  vydehi institute of medical sciences and research centre 
Address  whitefield, bangalore-560066 
Type of Sponsor  Research institution and hospital 
 
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 Pramathesh A  vydehi institute of medical sciences and research centre  Department of Anaesthesiology, Whitefield, bangalore-560066
Bangalore
KARNATAKA 
7760498220

pramathesh.a@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vydehi 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, (2) ICD-10 Condition: T07||Unspecified multiple injuries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  buprenorphine  Buprenorphine is a dehydroxylated phenanthrene and is chemically similar to other opioids such as hydrocodone, oxycodone, levorphanol, hydromorphone, oxymorphone, and others. Buprenorphine is a partial agonist at the m-opioid receptor (MOR) and an antagonist at k receptors. As a partial agonist, buprenorphine is able to activate MORs at low to moderate doses and it can achieve the same or superior analgesia compared to a full m-opioid agonist administered in a dose of 2mcg/kg body weight 
Comparator Agent  clonidine  Clonidine, a selective alpha-2 adrenergic agonist inhibits nociceptive impulses by activating postjunctional alpha-2 adrenoreceptors both at peripheral and spinal nerve endings. It improves block characteristics of local anaesthetics in peripheral nerve blocks without producing any side effects like sedation, bradycardia and hypotension as seen in spinal blocks Administered as a dose of 1.5mcg/kg body weight 
Intervention  INFRACLAVICULAR BRACHIAL PLEXUS BLOCK  Regional anaesthesia is comparatively safer and does not involve the potential side effects and complications that may arise from sedation and general anaesthesia. It is also effective as it more acceptable amongst the patients, thus providing the doctors an increased patient compliance and consent for surgery. The infraclavicular block is a safe and effective approach for Brachial plexus block that can provide anaesthesia for hands, wrist and forearm. Administered as 30ml of 0.5% Ropivacaine along with either 1.5mcg/kg of Clonidine or 2mcg/kg of Buprenorphine 
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients of either sex, aged 21-60 years, undergoing elective upper limb surgeries.
2. Patients belonging to American Society of Anesthesiologist (ASA) physical status I, II.
3. Patients within the weight range of 50-80kgs and within normal BMI.
 
 
ExclusionCriteria 
Details  1. Patient refusal for the study.
2. Patients with coagulopathy or on anticoagulants.
3. Patients with pre-existing neuropathy involving brachial plexus.
4. Patients who have undergone prior surgeries of the infraclavicular fossa.
5. Patients with localized skin infections at site of block.
6. Patients with hypersensitivity to local anaesthetic
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. To evaluate and compare the onset for sensory blockade.
2. To evaluate and compare the onset for motor blockade.
3. To evaluate and compare the duration of sensory blockade.
4. To evaluate and compare the duration of motor blockade.
 
5 mins
10 mins
15 mins
20 mins
25 mins
30 mins
1 hour
2 hours
3 hours
6 hours
12 hours
24 hours
 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess hemodynamic variables.
2. To identify adverse effects to the drugs.
 
hemodynamic variables are monitored in patients who receive the block for a duration of 24 hours & the at an interval sterting with 0min, 15min, 30min, 45min, 1hr, 2hrs, 3hrs, 6hrs, 12hrs & 24hrs
Adverse effects are noted upto a duration of 24hours if any 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   21/07/2024 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  available in person

  6. For how long will this data be available start date provided 17-03-2024 and end date provided 17-03-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

General anaesthesia was one of the most common methods employed to provide anaesthesia for upper limb surgeries. With the introduction of newer and safer local anaesthetics and better advantages, regional anaesthesia has taken over as the principal technique for upper limb surgeries.

Regional anaesthesia is comparatively safer and does not involve the potential side effects and complications that may arise from sedation and general anaesthesia. It is also effective as it more acceptable amongst the patients, thus providing the doctors an increased patient compliance and consent for surgery. The infraclavicular block is a safe and effective approach for Brachial plexus block that can provide anaesthesia for hands, wrist and forearm.

 

Ropivacaine is a propyl analogue of bupivacaine that has the same potency with longer duration of action and lesser cardiac and central nervous system toxicity of bupivacaine. Several adjuvants can be used to lengthen the duration of infraclavicular brachial plexus block such as clonidine, opioids, neostigmine, midazolam and buprenorphine [1].

 

Clonidine, a selective alpha-2 adrenergic agonist inhibits nociceptive impulses by activating postjunctional alpha-2 adrenoreceptors both at peripheral and spinal nerve endings. It improves block characteristics of local anaesthetics in peripheral nerve blocks without producing any side effects like sedation, bradycardia and hypotension as seen in spinal blocks [2].

 

Buprenorphine is a dehydroxylated phenanthrene and is chemically similar to other opioids such as hydrocodone, oxycodone, levorphanol, hydromorphone, oxymorphone, and others. Buprenorphine is a partial agonist at the m-opioid receptor (MOR) and an antagonist at k receptors. As a partial agonist, buprenorphine is able to activate MORs at low to moderate doses and it can achieve the same or superior analgesia compared to a full m-opioid agonist [3].

 

There are studies that compare the effects of adding clonidine as an adjuvant to ropivacaine or bupivacaine for brachial plexus blocks [1]. But there are limited studies with buprenorphine as an adjuvant in infraclavicular blocks.

After thorough research in literature, it was concluded that limited data is available that compares and assess the effects of these drugs as adjuvants to ropivacaine.

Hence, this study is being undertaken which intends to compare and evaluate the effects of clonidine and buprenorphine as adjuvants to ropivacaine in infraclavicular brachial plexus blocks.

 
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