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CTRI Number  CTRI/2021/05/033641 [Registered on: 17/05/2021] Trial Registered Prospectively
Last Modified On: 15/05/2021
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   A clinical trial to study the effects of two pain relief drugs, dexmedetomidine and buprenorphine added to levobupivacaine, a numbing drug injected below the curved front bone of the shoulder using an imaging machine in patients undergoing broken bone surgeries of upper extremity. 
Scientific Title of Study   Comparison of analgesic efficacy of dexmedetomidine and buprenorphine as an adjuvant to levobupivacaine in patients undergoing fracture surgeries of upper limb performed under ultrasound guided infraclavicular block - a randomised control trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sneka Priyadharsini V 
Designation  First Year Post graduate 
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,Melmaruvathur, Kancheepuram District

Kancheepuram
TAMIL NADU
603319
India 
Phone  9488319024  
Fax  044-27528305  
Email  snekamohan95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasath C 
Designation  Professor  
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,Melmaruvathur, Kancheepuram District

Kancheepuram
TAMIL NADU
603319
India 
Phone  9787740890  
Fax  044-27528305  
Email  drpathin2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sneka Priyadharsini V 
Designation  First Year Post graduate 
Affiliation  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Department of Anaesthesiology, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research,Melmaruvathur, Kancheepuram District

Kancheepuram
TAMIL NADU
603319
India 
Phone  9488319024  
Fax  044-27528305  
Email  snekamohan95@gmail.com  
 
Source of Monetary or Material Support  
Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research, Melmaruvathur, Kancheepuram District, Tamilnadu, India 603319 
 
Primary Sponsor  
Name  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research 
Address  Melmaruvathur, Kancheepuram District, Tamilnadu, India 603319 
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 Sneka Priyadharsini V  Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  Department of anaesthesiology ,operation theatre no.4 and no.5 and post operative recovery room,operation theatre complex, B zone , first floor, hospital block.
Kancheepuram
TAMIL NADU 		 9488319024

snekamohan95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: PCS||, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Buprenorphine as additive to infraclavicular levobupivacaine  150 micrograms of buprenorphine(0.5ml) as additive to infraclavicular 0.5% levobupivacaine (29.5ml) for patients undergoing upper limb fracture surgeries under ultrasound-guided infraclavicular brachial plexus block. 
Intervention  Dexmedetomidine as additive to infraclavicular levobupivacaine  50 micrograms of dexmedetomidine (0.5ml) as additive to infraclavicular 0.5% levobupivacaine (29.5ml) for patients undergoing upper limb fracture surgeries under ultrasound-guided infraclavicular brachial plexus block. 
Comparator Agent  Normal saline as additive to infraclavicular levobupivacaine  0.5ml of normal saline as additive to infraclavicular 0.5% levobupivacaine (29.5ml) for patients undergoing upper limb fracture surgeries under ultrasound-guided infraclavicular brachial plexus block. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I or II patients
Age 18–60 years, scheduled for surgeries of the forearm, wrist and hand under US-guided infraclavicular brachial plexus block
 
 
ExclusionCriteria 
Details  Patients aged <18 years or >60 years.
Patients having body weight <40 kg and >70 Kg.
Any contraindication to regional anesthesia.
Refusal for infraclavicular block and inability to give consent
Patients undergoing surgeries of arm, elbow, shoulder
Patients having peripheral neuropathy or hypersensitivity to local anaesthetic agents.
Patients having history of seizures.
History of pulmonary, cardiac, hematological, endocrinal, and neuromuscular disorders.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
post operative analgesia using VAS pain scale  postoperative period 2nd,4th,6th,8th,12th,16th,20th,24th,28th,32nd,36th,40th,44th,48th hour 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic parameters ( Heart rate, respiratory rate, systolic blood pressure,diastolic blood pressure, mean arterial pressure, oxygen saturation)   baseline, 2 minutes, 4 minutes, 6 minutes, 8 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 16 hours, 20 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours 
Sensory block(complete loss of sensation to pin prick to return of sensation)   post operative period upto 48 hours 
Motor block ( onset of motor blockade and return to bromage score 0)   post operative period upto 48 hours 
Anticipated side effects   post operative period upto 48 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   15/06/2021 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil will be published after completion of the study 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  snekamohan95@gmail.com

  6. For how long will this data be available start date provided 01-06-2021 and end date provided 01-06-2024?
    Response - Beginning 9 months and ending 36 months following article publication.

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

This study is a randomized single blinded trial comparing the effectiveness of adding dexmedetomidine and buprenorphine to infraclavicular levobupivacaine for fracture surgeries of upper limb that will be conducted in Melmaruvathur Adhiparasakthi Institute of Medical Sciences and Research. Primary outcome will be postoperative analgesia . Secondary outcome will be hemodynamic parameters( Heart rate, respiratory rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, oxygen saturation) , complete loss of sensation to pin prick to return of  sensation , onset of motor blockade and return to Bromage score 0 , and anticipated side effects.

 
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