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CTRI Number  CTRI/2019/07/020470 [Registered on: 31/07/2019] Trial Registered Prospectively
Last Modified On: 30/07/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A comparative study of anaesthetic injection into the nerves above and below collar bone for hand surgeries using ultrasound 
Scientific Title of Study   A comparison between ultrasound guided supraclavicular and infraclavicular approach to brachial plexus block for upper limb surgery: a randomized observer blinded study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anis Fathima 
Designation  Junior Resident 
Affiliation  PONDICHERRY INSTITUTE OF MEDICAL SCIENCE 
Address  Room no 101,Annex PG hostel Pondicherry Institute Of Medical Sciences Kalapet Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9786635828  
Fax    
Email  mailanisfathima@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nagalakshmi 
Designation  Associate Professor 
Affiliation  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES 
Address  Associate Professor Department Of Anaesthesiology Pondicherry Institute Of medical sciences, Kalapet, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9894510137  
Fax    
Email  vedha83@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nagalakshmi 
Designation  Associate Professor 
Affiliation  PONDICHERRY INSTITUTE OF MEDICAL SCIENCES 
Address  Associate Professor Department Of Anaesthesiology Pondicherry Institute Of medical sciences, Kalapet, Puducherry

Pondicherry
PONDICHERRY
605014
India 
Phone  9894510137  
Fax    
Email  vedha83@gmail.com  
 
Source of Monetary or Material Support  
Pondicherry Institute Of medical sciences, Kalapet,Ganapathichettikulam Puducherry. Pin:605014  
 
Primary Sponsor  
Name  Dr Anis Fathima 
Address  Junior Resident, Department Of Anaesthesiology, PIMS, Puducherry Pin 605014 India 
Type of Sponsor  Other [Dr Anis Fathima] 
 
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 Anis Fathima  Pondicherry Institute of Medical Sciences  Pondicherry Institute of Medical Sciences is a multispeciality hospital and well reputed teaching institute at kalapet in the Union territory of Puducherry Departmentof Anaesthesiology Kalathumettupathai, Ganapathichettikulam, Kalapet, Puducherry, 605014 India
Pondicherry
PONDICHERRY 
9786635828

mailanisfathima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITTEE(IEC), Registered with CDSCO- Reg No ECR/400/Inst/Py/2013, Pondicherry Institute Of Medical Sciences, Kalapet, Puducherry - 605014  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S578||Crushing injury of forearm, (2) ICD-10 Condition: S629||Unspecified fracture of wrist andhand,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  infraclavicular block  patients who receive infraclavicular block for upper limb surgery 
Comparator Agent  supraclavicular block  patients who receive supraclavicular block for upper limb surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients according to American Society of Anaesthesiologists grade 1 or 2.

2.Age between 18-60 years

3.Surgeries involving upper limb (hand and forearm) lasting more than 1 & 1/2 hours
 
 
ExclusionCriteria 
Details  4. BMI morethan 30 kg/m2

5. Pregnant women

6. Bleeding disorders, anticoagulant therapy or deranged coagulation profile

7. Pre-excisting motor or sensory deficit in the operative limb

8. Infection in the area of injection

9.Hypersensitivity to local anaesthetic agents
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the onset of sensory and motor blockade of brachial plexus between
Group A- block by infraclavicular approach
Group B- block by supraclavicular approach
 
24 - 48 hrs
 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the duration of sensory and motor block between two Groups.
2.To compare the occurrence of ulnar nerve sparing between the two groups.
3.To detect and document any intraoperative /postoperative complications if present.
 
24 - 48 hrs 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 2/ Phase 3 
Date of First Enrollment (India)   07/08/2019 
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)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   study will be published once it gets over 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Upperlimb surgeries can be performed under general or regional anaesthesia. Regional anaesthesia offers  several advantages over general  anaesthesia such as a conscious patient , avoidance of polypharmacy and airway Intervention, better hemodynamics, good post- operative analgesia, early resumption of activities, reduced hospital stay and improved functional outcome. Brachial plexus block at the level of the clavicle can anaesthetize all four distal upper extremity nerve territories producing an intense blockage. Supraclavicular brachial plexus block is a popular technique for upper limb surgeries because of its quick onset and high success rate. This is because at this level, the brachial plexus elements are tightly grouped and produces a good neurological block. Corner pocket sparing and thereby a less dense ulnar blockade is a problem in supraclavicular block.  So supraclavicular blockade requires a two point injection.  There is a  possibility of horner’s syndrome, phrenic nerve palsy and pneumothorax which may also be considered as its disadvantage. The main advantage of infraclavicular block is the fewer incidences of complications with reduced the risks of inadvertent lung/pleural puncture and avoidance of injury to the neurovascular structures in the neck. It is an ideal site for catheter technique for continuous infusion of local anaesthetics. There is lesser incidence of ulnar nerve sparing with single point injection. The disadvantage is that plexus is situated deeper at this level and the angle of approach is more acute. This makes the visualization of the relevant anatomy and the needle tip, challenging in inexperienced hands and in obese patients. Although both supraclavicular and infraclavicular blocks can be performed for upper limb surgeries, anaesthesiologists often have an inclination to supraclavicular block over infraclavicular block because of an ease of administration. The advent of real time ultrasound helps in direct visualisation of nerves and their surrounding anatomy. It also allows for continuous    observation of the needle tip and the spread of local anaesthetics, reduced local anaesthetic dose required to achieve a good block, avoidance of injury to the nearby vascular structures making ultrasound guided brachial plexus block highly appealing to anaesthesiologists. The rational of this study is to evaluate the efficacy of ultrasound guided infraclavicular approach of brachial plexus block compared to ultrasound guided supraclavicular approach of brachial plexus block in upper limb surgeries.

 

 
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