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CTRI Number  CTRI/2024/03/063916 [Registered on: 11/03/2024] Trial Registered Prospectively
Last Modified On: 09/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the efficacy of single vs triple injection above the clavicle so as to numb the hand for orthopaedic trauma surgery 
Scientific Title of Study   Comparison of single vs triple aliquot injection for supraclavicular brachial plexus block in upper limb orthopaedic trauma surgeries : A Randomised controlled 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  Dr.Babita Gupta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 124 JPNATC,AIIMS Delhi Hospital, Ansari Nagar East Delhi New Delhi 110029 India

South
DELHI
110029
India 
Phone  9818302776  
Fax    
Email  drbabitagupta@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Babita Gupta 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Room 124 JPNATC,AIIMS Delhi Hospital, Ansari Nagar East Delhi New Delhi 110029 India

South
DELHI
110029
India 
Phone  9818302776  
Fax    
Email  drbabitagupta@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  NILIMA MANDAL 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Anesthesiology office, AIIMS Hospital, Ansari Nagar East Delhi New Delhi 110029 India

South
DELHI
110029
India 
Phone  09304495962  
Fax    
Email  nilimamandal1306@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology , Pain Medicine and Critical Care AIIMS DELHI 110029 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Anesthesiology office, AIIMS Hospital, Ansari Nagar East Delhi New Delhi 110029 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 
DrNilima Mandal  AIIMS Hospital  Anesthesiology office Room 5011, AIIMS Hospital, Ansari Nagar East Delhi New Delhi 110029 India
South
DELHI 
09304495962

nilimamandal1306@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute of Ethics Committee for postgraduate research,AIIMS Delhi  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 
Comparator Agent  Single injection technique supraclavicular block  Single injection of 15 ml of 0.75 % ropivacaine with 1 mcg/kg clonidine infiltrated around nerves before proceeding for surgery 
Intervention  Triple aliquot injection supraclavicular block  Triple aliquots injection of 0.75% ropivacaine with 1mcg/kg clonidine infiltrated in above,middle and corner pocket in divided dose 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1) Age 18-65 years
2) ASA 3)BMI<35kgm2
 
 
ExclusionCriteria 
Details  1) Patient refusal to participate
2)Known allergy to anesthetic drug
3)Infection at local site
4)Pregnancy and breast feeding
5)Known neuropathy involving upper extremities
6)Coagulation disorder
7)COPD and respiratory disorder 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the anesthesia onset time  5 min 10 min 15 min 20 min 25 min 30 min 
 
Secondary Outcome  
Outcome  TimePoints 
1)Duration of action
2)Duration of post op analgesia
3)Rate of complications
4)Need for repeat block/rescue analgesia 
Immediate 2h 4h 6h 12h 24h postop day 5 
 
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   Phase 3 
Date of First Enrollment (India)   19/03/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - NO
Brief Summary  

Supraclavicular block anesthetizes the brachial plexus where it is in its most compact form, thus providing a complete and reliable block for upper extremity surgery.1 Although the single injection (SI) ultrasound-guided corner pocket technique has been reported to have the highest success rate, this technique may miss the upper part of the plexus, resulting in an incomplete block. Cadaver and patient studies by using dye injections have demonstrated that injection into a single location does not result in the spread of the injected dye into all the compartments. Septae or a tight muscular membrane between the scalene muscles were found to separate roots of the plexus. Several studies comparing different approaches for brachial plexus block have demonstrated multiple injection techniques to be more successful, resulting in a faster onset of anesthesia and higher success rates with no increased incidence in complications. However, these trials did not show consistent results regarding the onset of block or the nerves blocked. The aim of this study was to compare the sensory block success rate of SI versus triple injection (TI). We hypothesized that a TI performed at the upper, middle, and lower parts of the plexus would have a higher success rate compared with the SI technique. In single injection using in plane approach a 22g 5 cm needle will be advanced until the tip is at the junction of first rib and subclavian artery.15 ml of 0.75% ropivacaine with 1 mcg/kg clonidine will be injected with negative aspiration. Similarly for  triple injection 5 ml each of the drug will be injected in corner , middle and above pocket. The time of onset of block will be measured as the primary outcome. We hypothesized that triple injection is more efficacious than single injection.

 
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