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CTRI Number  CTRI/2025/04/084254 [Registered on: 07/04/2025] Trial Registered Prospectively
Last Modified On: 05/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative Study of Incidence of Hemidiaphragmatic paralysis in two approaches of ultrasound guided Brachial plexus block: Supraclavicular and Costoclavicular  
Scientific Title of Study   Incidence of Hemidiaphragmatic Paralysis in Brachial Plexus Block with Supraclavicular approach versus Costoclavicular approach in patients undergoing upper limb surgery- A Prospective Randomized Comparative Study 
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 Prateek Singh Bais 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8601339323  
Fax    
Email  prateek.bais.lko@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prashansa Attri 
Designation  PG student  
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  7017819263  
Fax    
Email  dr.prashansa03@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prateek Singh Bais 
Designation  Associate Professor 
Affiliation  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow 
Address  Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8601339323  
Fax    
Email  prateek.bais.lko@gmail.com  
 
Source of Monetary or Material Support  
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 226014 
 
Primary Sponsor  
Name  Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh India  
Address  Department Of Anaesthesiology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh India 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 Prateek Singh Bais  Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 226014  Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 226014
Lucknow
UTTAR PRADESH 
8601339323

prateek.bais.lko@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 
Intervention  Incidence of Hemidiaphragmatic Paralysis in Brachial Plexus Block with costoclavicular approach using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio   Costoclavicular block using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio After 20 mins, sensory and motor effect of the block will be checked. At 25 mins, patient will be assessed for baseline parameters of diaphragmatic function: Diaphragmatic excursion, Diaphragm thickening fraction under ultrasound guidance, Breath holding test, Cough test and Spirometry will be performed. 
Comparator Agent  Incidence of Hemidiaphragmatic Paralysis in Brachial Plexus Block with supraclavicular approach using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio  Supraclavicular block using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio After 20 mins, sensory and motor effect of the block will be checked. At 25 mins, patient will be assessed for baseline parameters of diaphragmatic function: Diaphragmatic excursion, Diaphragm thickening fraction under ultrasound guidance, Breath holding test, Cough test and Spirometry will be performed. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients willing to give written and informed consent
Age group: 18- 65 years
Both genders
American Society of Anaesthesiologists (ASA) physical status I or II patients
Scheduled for upper limb surgeries (including elbow, forearm, hand, and wrist surgery)
 
 
ExclusionCriteria 
Details  Patient refusal
BMI more than 30kg/m2
Hypersensitivity to local anaesthetics
Pre-existing neuropathy on surgical limb
Significant pulmonary disease
Coagulopathy, sepsis, infection on block site
Conversion to general anaesthesia
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Incidence of hemidiaphragmatic paralysis in brachial plexus block with supraclavicular vs costoclavicular approach  25 minutes 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess pulmonary function before & after the block using spirometer, breath holding test & cough test
2. To assess scan time & needle time in minutes in two approaches
3. To assess post operative pain using numerical rating scale
4. Time to first rescue analgesia
5. Any adverse events/ complications will be noted 
24 hours 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   16/04/2025 
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="5"
Days="30" 
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  

Upper limb orthopaedic surgeries have shown to fasten and improve clinical outcome of trauma patients. Brachial plexus block is an established mode of anaesthesia and analgesia in upper limb orthopaedic procedures. Hemidiaphragmatic Paralysis (HDP) is a frequent complication of brachial plexus block performed with supraclavicular approach as a result of unintentional blockade of phrenic nerve. It is well tolerated in healthy patients, but can become a critical issue in patients with compromised pulmonary function. Costoclavicular brachial plexus block is an emerging, recently introduced infraclavicular approach, exhibiting an accelerated and reliable blockade. The compact organization of plexus at this level is advantageous as lesser volumes of local anaesthetic is required compared to other approaches of infraclavicular block. In our proposed study we aim to compare incidence of hemidiaphragmatic paralysis in brachial plexus block with supraclavicular approach vs costoclavicular approach.

Primary objective is to compare the incidence of hemidiaphragmatic paralysis by assessing diaphragmatic function with diaphragm excursion and diaphragm thickness fraction (DTF) using ultrasound and Secondary objectives are: to assess pulmonary function before and after the block using spirometer, breath holding test and cough test, scan time and needle time in minutes, post operative pain using numerical rating scale (NRS), time to first rescue analgesia and any complication/adverse events will be noted.

Following approval from the Institutional Ethics Committee and registering the trial in CTRI and after obtaining written and informed consent from the patients, a prospective randomized comparative study will be conducted will be conducted in Apex Trauma Centre, SGPGIMS. over a period of 18 months. Patients will undergo pre anaesthetic check up and will be prepared as per standard anesthesia practices. Patients will be randomly divided into two groups

Group 1: Brachial plexus block using Costoclavicular approach

Group 2: Brachial plexus block using Supraclavicular approach 

Patient will be shifted in the operating room, all routine ASA standard monitors, IV line and supplemental oxygen will be attached. Baseline parameters of diaphragmatic function: Diaphragmatic excursion, Diaphragm thickening fraction under ultrasound guidance, Breath holding test, Cough test and Spirometry will be performed. Blocks will be performed under ultrasound guidance using 25 ml of local anesthetic containing 0.75% ropivacaine and 2% lignocaine in (1:1), scan time and needle time will be noted simultaneously. After 20 mins, sensory and motor effect of the block will be checked. At 25 mins, patient will be reassessed for the same baseline parameters and any obvious discomfort, adverse events, complications such as pneumothorax, vascular puncture, local anaesthetic systemic toxicity, hematoma, and Horner’s syndrome will be recorded, if present it will be treated accordingly and the patient will be excluded from the trial. If absent, the patient will be handed over to the surgical team for intervention. IV sedation using dexmedetomidine (loading dose 1mcg/kg over 10 mins, maintenance dose of 0.5mcg/kg/hr) will be started and continued intraoperatively. 

After completion of surgery, patient will be shifted to Post Operative ICU for observation. NRS scores for pain and time of requirement of first rescue analgesia will be recorded. Any complications in intraoperative and postoperative period will be noted and intervention will be done accordingly.


 
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