FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/01/022714 [Registered on: 13/01/2020] Trial Registered Retrospectively
Last Modified On: 12/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   A study to find minimum volume of a particular local painkiller drug required for ultrasound guided forearm nerve block 
Scientific Title of Study   A study to find minimum effective volume of 0.5% ropivacaine for ultrasound guided costoclavicular block 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  chhavi sawhney 
Designation  professor 
Affiliation  All India Institute of Medical Sciences, new delhi 
Address  8th floor,ab8 recovery, emergency block, department of anesthesiology, aiims new delhi

South
DELHI
110029
India 
Phone  9818357051  
Fax    
Email  drchhavisawhney@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  chhavi sawhney 
Designation  professor 
Affiliation  All India Institute of Medical Sciences, new delhi 
Address  8th floor,ab8 recovery, emergency block, department of anesthesiology, aiims new delhi
aiims
South
DELHI
110029
India 
Phone  9818357051  
Fax    
Email  drchhavisawhney@gmail.com  
 
Details of Contact Person
Public Query  
Name  chhavi sawhney 
Designation  professor 
Affiliation  All India Institute of Medical Sciences, new delhi 
Address  8th floor,ab8 recovery, emergency block, department of anesthesiology, aiims new delhi
aiims
South
DELHI
110029
India 
Phone  9818357051  
Fax    
Email  drchhavisawhney@gmail.com  
 
Source of Monetary or Material Support  
Deptt of Anaesthesiology Pain medicine and critical care AIIMS New Delhi 
 
Primary Sponsor  
Name  all india institute of medical sciences 
Address  aiims new delhi 
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 
Bijaya Laxmi  Deptt of anaesthesiology , pain medicine and critical care  8th floor,ab8 recovery, emergency block, department of anesthesiology, aiims new delhi
New Delhi
DELHI 		 9013923036

daulatia353@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Postgraduate Research AIIMS , Ansari Nagar ,New Delhi Room no 102 , 1st floor Old O.T. Block  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  A patient with elbow , wrist or hand injury, (1) ICD-10 Condition: S529||Unspecified fracture of forearm, (2) ICD-10 Condition: S529||Unspecified fracture of forearm,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  not applicable  not applicable 
Intervention  volume of drug  In ultrasound guided costoclavicular block with 0.5 % ropivacaine , first candidate will receive 20ml of drug depending upon the success or failure of the block next patient receives 2ml more or less of the drug till a minimum value is reached. Once a minimum dose is achieved it will be used in 20 consecutive patients 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  All adults posted for surgeries of elbow , forearm , wrist and hand
American society of anaesthesia grade I/II patient
Body mass index 18 to 30 kg/ m sq
 
 
ExclusionCriteria 
Details  Patients refusal for brachial plexus block
Sepsis
coagulopathy
Known neuropathy or injury of musculocutaneous , radial , ulnar or median nerve
Known allergy to local anaesthetic drugs
Abnormal neck or shoulder anatomy
Previous surgery in infraclavicular fossa 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to calculate mev of ropivacaine in 90% of patients for costocavicular bliock  Adequate surgical anaesthesia at 30 minutes post block assessment interval 
 
Secondary Outcome  
Outcome  TimePoints 
1.Supplementation required to achieve adequate surgical anaesthesia
2.Tourniquet pain
3.Onset time of adequate surgical anaesthesia
4.Block performance time
5.Incidence of immediate complications like vascular puncture, pleural puncture, paresthesias or local anaesthetic toxicity. Delayed complications like persistent paresthesias and motor deficit will be enquired one week after the block
 		 nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   12/05/2018 
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)  Open to Recruitment 
Publication Details   .Karmakar MK , Blanch XS, Songthamwat B, Tsui BCH. Benifits of Costoclavicular Space for Ultrasound – Guided Infraclavicular Brachial Plexus Block: Description of costoclavicular approach. Regional Anesthesia Pain Medicine 2015; 40(3) :287-8 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The primary objective is to find the minimum effective volume of 0.5% ropivacaine  in 90% patients ( MEV90)  for ultrasound guided costoclavicular approach of infraclavicular brachial plexus block for which adults between 18 to 65 yrs undergoing hand wrist and elbow surgery  will be chosen , excluding the above mentioned categories . Then after preanaesthetic check up and explaining pain score to patients selected ultrasound guided block will be given prior to surgery . The volume of the drug will be based on baised coin method and up and down sequece in which volume of the drug for next patient is based on result of the previous . The initial volume will be 20 ml and based on the success of this the next volume will be 2ml lesser , this initial volume is based on the study done supraclavicular for MEV 50 which was 23 ml . After block application success will be assessed based on sensory and motor blockade scoring at the end of 30 min. The maximum volume decided is 25 ml to avoid drug toxicity . If the block fails then next patient will get 25 ml . A fixed minimum no of 20 positive responses will be chosen for our dose finding study. The final sample is estimated by simulations to be 52 plus/minus 2 .

 
Close