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CTRI Number  CTRI/2023/03/050396 [Registered on: 06/03/2023] Trial Registered Prospectively
Last Modified On: 12/04/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study selective nerve block versus axillary plexus block for control of upper limb pain due to trauma 
Scientific Title of Study   Efficacy of ultrasound-guided selective peripheral nerve block compared to axillary brachial plexus block for control of pain due to upper extremity trauma: A randomized controlled trial 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chitta Ranjan Mohanty 
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Trauma and Emergency Room No 405 Academic 4th floor AIIMS, BBSR Sijua

Khordha
ORISSA
751019
India 
Phone  8280458275  
Fax    
Email  drchitta8@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chitta Ranjan Mohanty 
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Trauma and Emergency Room No 405 4th floor academic block Sijua

Khordha
ORISSA
751019
India 
Phone  8280458275  
Fax    
Email  drchitta8@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chitta Ranjan Mohanty 
Designation  Associate Professor  
Affiliation  All India Institute of Medical Sciences Bhubaneswar 
Address  Department of Trauma and Emergency 4th floor Academic block Sijua

Khordha
ORISSA
751019
India 
Phone  8280458275  
Fax    
Email  drchitta8@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences Bhubaneswar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar 
Address  AIIMS Bhubaneswar SIJUA 751019 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
All India Institute of Medical Sciences Bhubaneswar  AIIMS Bhubaneswar SIJUA 751019 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chitta Ranjan Mohanty  All India Institute of Medical Sciences Bhubaneswar  Department of Trauma and Emergency Ground Floor Sijua 751019
Khordha
ORISSA 
08280458275

drchitta8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE ALL INDIA INSTITUTE OF MEDICAL SCIENCES BHUBANESWAR  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-peripheral nerve block (Procedure Reference: peripheral nerve block, Procedure details: ultrasound-guided peripheral nerve block, Procedure details: The patient will be positioned as per the requirement of the specific nerve block. 7.5 MHz linear transducer will be used for anatomical location and performance of nerve block. Upon identification of the respective nerve, a 22-gauge, 5-cm stimuplex needle (B-Braun Medical Inc, Geermany) will be inserted in-plane technique. After negative aspiration 2.5-3 ml of 0.375% ropivacaine will be injected near the nerve.) The duration of inteve)
2Comparator Arm (Non Ayurveda)-Axillary brachial plexus blockAxillary brachial plexus block will be performed under ultrasound guidance using 0.375% ropivacaine. The stimuplex needle will be introduced under ultrasound guidance near the nerve and the drug will be injected around the nerve plexus after negative aspiration. The total duration of intervention will be 10 to 20 minutes
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  (i)Upper extremity injury with pain score of ≥ 5 in Numerical rating scale (NRS).
(ii)Able to consent and actively participate in the study.
 
 
ExclusionCriteria 
Details  (i) Patient refusing consent to participate in the study.
(ii) Any contraindication for regional anesthesia.
(iii) Multiple limb injury.
(iv) Any pre-existing neurological illness which can be due to which the patient has an abnormal appreciation of pain stimulus.
(v) Patient unable to understand the NRS score.
(vi) Patient with polytrauma needing urgent surgery or surgery within the possible duration of the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of pain score by NRS   At 30 minutes, one hour, two-hour, three-hour, four hour and six hours after the block 
 
Secondary Outcome  
Outcome  TimePoints 
Sensorimotor evaluation   At 30 minutes, one hour, two-hour, three-hour, four hour and six hours after the block 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
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)   13/03/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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   This randomised open labeled trial will compare efficacy of ultrasound guided axillary plexus block with selective peripheral nerve block. Ninety-four patients who met the inclusion criteria will be included for the study. They will be randomly divided into two groups based on a computer-generated randomised sequence and allocated in two groups by SNOSE technique.  Primary outcome will be pain assed in NRS at 30 minutes after performing the nerve or plexus block.  
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