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CTRI Number  CTRI/2025/04/085876 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 28/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of Two Anaesthesia Techniques for Pain Relief in upper limb fractures. 
Scientific Title of Study   Comparative Evaluation of Axillary Approach v/s Retroclavicular (RAPTIR) Approach in Ultrasound Guided Brachial Plexus Block for Distal Upper Limb Surgery: A Prospective Randomized Comparative 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 Suruchi 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Post Graduate Institue of medical sciences 
Address  Department of Anaesthesiology, First floor, A block,Sanjay Gandhi Post Graduate Institue of medical sciences, Raibareilly road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9786025292  
Fax    
Email  suruchi0904@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anjali Chaudhary 
Designation  PG Resident 
Affiliation  Sanjay Gandhi Post Graduate Institue of medical sciences 
Address  Department of Anaesthesiology, First floor, A block,Sanjay Gandhi Post Graduate Institue of medical sciences, Raibareilly road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8447234721  
Fax    
Email  anjalichaudhary1210@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Suruchi 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Post Graduate Institue of medical sciences 
Address  Department of Anaesthesiology, First floor, A block,Sanjay Gandhi Post Graduate Institue of medical sciences, Raibareilly road, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  9786025292  
Fax    
Email  suruchi0904@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Post Graduate Institue of medical sciences,Raibareilly road, lucknow, Uttar Pradesh, 226014 
 
Primary Sponsor  
Name  Sanjay Gandhi Post Graduate Institue of medical sciences, 
Address  Raibareilly road, lucknow, Uttar Pradesh, 226014 
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 
Dr Suruchi  Sanjay Gandhi Post Graduate Institue of medical sciences  Department of Anaesthesiology, First floor, A block
Lucknow
UTTAR PRADESH 
9786025292

suruchi0904@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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  Axillary approach to Brachial plexus block  Drug used: 25 ml of 0.5% bupivacaine Total duration of placement of block will be noted. 
Intervention  RAPTIR- Retroclavicular approach to the infraclavicular Block  Drug used: 25 ml of 0.5% bupivacaine Total duration of placement of block will be noted. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Elective or urgent surgery of the hand wrist forearm
American Society of Anaesthesiologists ASA class I to III
 
 
ExclusionCriteria 
Details  Patient refusal
Previous surgery or gross anatomical deformity/Fracture of the clavicle
BMI greater than 30
Systemic or local infection at the needle entry point
Coagulopathy
Severe pulmonary condition
Local anaesthetic allergy
Pre-existing neurologic symptoms in the ipsilateral limb
Pregnancy

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome is the performance time expressed in minutes.  Measured at 15 minutes from the start of the procedure 
 
Secondary Outcome  
Outcome  TimePoints 
Sensory block assessment
Motor block assessment
Onset of block motor block (14 out of 16)
Success of block
Pain during the procedure
Pain in first 24 hours
Time to first analgesic request
Early and late complications
 
1.Sensory block assessed at 5 10 20 and 30 mins.
2.Motor block assesses at 5 10 20 and 30 mins.
3.Pain in first 24 hours
4.Time to first analgesic request
 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   02/06/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

·       

Regional anesthesia for upper limb surgery provides many advantages over general anesthesia, especially in orthopedic surgery.The Brachial plexus block (BPB) is less invasive and as equally effective as general anaesthesia to anaesthetize the upper limbs. The most important of them is the control of postoperative pain, which results in decreased postoperative opioid requirements and the patient’s recovery time. With the introduction of the ultrasound-guided technique, the success rate has reached 95-100%. Therefore, a different indicator is required in comparative studies today, and the procedure time is considered as an important indicator after the success rate. There have been no comparative studies between the widely practiced Axillary brachial plexus block and the recently introduced and relatively less practiced  Retroclavicular approach to Infraclavicular brachial plexus block (RAPTIR).Thus we aim to conduct this study to compare various parameters of both these approaches with the main emphasis on the time to perform these blocks.The primary objective is to determine the procedure time which is summation of imaging time and needling time. The secondary objectives include analysis of onset time, block success rate, procedure related pain, NRS (static/dynamic) Score in postoperative period up to 24 hrs, Time to first rescue analgesia, Complications. Following approval from the Institutional Ethics Committee and registering the trial in CTRI and after obtaining written and informed consent from the patients, a randomised comparative study will be conducted over a period of 18 months in patients undergoing distal upper limb surgeries. Patients will be randomly allocated by use of block randomization method using software_” sealed envelope”. The study population will be above years, ASA I,II and III, undergoing distal upper limb surgery. Exclusion criteria includes patient refusal, previous surgery or gross anatomical deformity/Fracture of the clavicle, BMI >30 kg/m2, Systemic or local infection at the needle entry point, Coagulopathy, Severe pulmonary condition, Local anaesthetic allergy, Pre-existing neurologic symptoms in the ipsilateral limb, Pregnancy. As per randomization, patients will be given either axillary block or RAPTIR block with 25 ml of 0.5% Bupivacaine. The primary outcome is the performance time, expressed in minutes. The performance time corresponds to the sum of imaging time and needling time, which both are secondary outcomes. Secondary outcome measures: Onset of block – Measured as Composite score of sensory and motor block (14 out of 16), Success of plexus block, Pain assessment will be done using a 10-cm Numeric Rating Scale immediately after the block and in first 24 hours, Time to first analgesic request, Early and late complications: the incidence of needle-induced paresthesia, vascular puncture, Horner syndrome, dyspnea, and symptoms of LA toxicity will be noted. All patients will be followed at 48 hours after surgery to ask for any delayed complications, such as dyspnea, paresthesia, weaknesses, pain at the puncture site or haematoma.

 
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