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CTRI Number  CTRI/2022/06/043115 [Registered on: 09/06/2022] Trial Registered Prospectively
Last Modified On: 07/06/2022
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   COMPARISON OF INFRACLAVICULAR BRACHIAL PLEXUS BLOCK AND COMBINATION OF INFRACLAVICULAR BRACHIAL PLEXUS BLOCK WITH SUPRASCAPULAR NERVE BLOCK FOR SHOULDER SURGERIES IN TERMS OF POST OPERATIVE PAIN MANAGEMENT AND QUALITY OF LIFE. 
Scientific Title of Study   Comparison of infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries: A Randomised Control Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parul Saxena 
Designation  Junior Resident 
Affiliation  King George medical university  
Address  DEPARTMENT OF ANAESTHESIOLOGY KING GEORGE MEDICAL UNIVERSITY LUCKNOW UTTAR PRADESH

Lucknow
UTTAR PRADESH
226003
India 
Phone  7754938774  
Fax    
Email  Parul.saxena29@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Manish Kr Singh 
Designation  Assistant Professor 
Affiliation  KGMU 
Address  Department of anaesthesia King George medical university Lucknow Uttar pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  9453625852  
Fax    
Email  manish.is.singh34@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manish Kr Singh 
Designation  Assistant Professor 
Affiliation  KGMU 
Address  Department of anaesthesia King George medical university Lucknow Uttar pradesh

Lucknow
UTTAR PRADESH
226003
India 
Phone  9453625852  
Fax    
Email  manish.is.singh34@gmail.com  
 
Source of Monetary or Material Support  
King George medical university  
 
Primary Sponsor  
Name  KIng George medical university  
Address  King George medical university Lucknow Uttar Pradesh  
Type of Sponsor  Government medical college 
 
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 
Parul saxena  King George Medical University  Department of Anaesthesiology and critical care King George Medical College Lucknow Uttar pradesh
Lucknow
UTTAR PRADESH 
7754938774

Parul.saxena29@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S424||Fracture of lower end of humerus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A  Brachial plexus block using infraclavicular approach for shoulder surgeries. Sample size is 31 patients in each group over a study duration of three months. 
Comparator Agent  Group b  Brachial plexus block using infraclavicular approach in combination with supra scapular nerve block for shoulder surgeries . Sample size will be 31 in each group over a duration of three months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of either sex, aged 18-65 years.
Patients giving written informed consent will be taken.
ASA Grade I, II and III
Shoulder Surgeries
 
 
ExclusionCriteria 
Details  morbid obesity
pregnancy
Allergy
Patients not giving consent
Coagulopathy
Local site infections 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia using Visual Analogue Score (VAS SCORE) during first 24 hrs of surgery at intervals of 1,3,6,12 and 24 hours.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries in terms of patient satisfaction.
2. To compare the use of other analgesics in post operative period in infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block with suprascapular nerve block for shoulder surgeries. 
3 months 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   15/06/2022 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  
Aim:
To compare the efficacy of infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia for shoulder surgery .
Primary Objectives:
To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block in terms of post operative analgesia using Visual Analogue Score (VAS SCORE) during first 24 hrs of surgery at intervals of 1,3,6,12 and 24 hours.
Secondary Objectives:
1. To compare infraclavicular brachial plexus block and the combination of infraclavicular brachial plexus block and suprascapular nerve block for shoulder surgeries in terms of patient satisfaction.
2. To compare the use of other analgesics in post operative period in infraclavicular brachial plexus block and combination of infraclavicular brachial plexus block with suprascapular nerve block for shoulder surgeries.
 
Study settings:
MATERIAL AND METHODS
The study will be conducted in Department of Anaesthesiology, King George’s Medical University, Lucknow
Study duration:
One year
Study design:
Single blind,Hospital based,Prospective Randomized controlled study Sample Size: 31 in each group.
Inclusion Criteria:
Patients of either sex, aged 18-65 years.
Patients giving written informed consent will be taken.
ASA Grade I, II and III Shoulder Surgeries
Exclusion criteria
 morbid obesity
 pregnancy
Allergy
Patients not giving consent
Coagulopathy
Local site infections
Methodology:
The study will be conducted after getting approval from ethics committee of King Georges Medical University, Lucknow after taking patient’s consent. The patients will be randomly allocated in either of the two groups after fulfilling the inclusion criteria mentioned above using opaque sealed envelope technique. The groups are as follows,
STUDY GROUPS
• Group-A : brachial plexus block using infraclavicular approach for Shoulder Surgeries
• Group-B : brachial plexus block using infraclavicular approach in combination with suprascapular nerve block for Shoulder Surgeries.
STUDY PROTOCOL
The study will be conducted in a single blind manner where the participants will be blinded to the study. Written and informed consent will be taken from all participants. On the evening before surgery,routine pre-anaesthetic checkup will be done in all patients. Upon arrival to the operating room,routine monitoring including electrocardiography,pulse oximetry and blood pressure monitoring will be done. Part preparation will be done and infraclavicular brachial plexus block and combined infraclavicular Brachial plexus block with suprascapular nerve block will be given according to allocation of the patients in each group under all aseptic conditions.
The patients will be monitored for post operative analgesia for a duration of 24 hours at intervals of 1,3,6,12,24 hours using Visual Analogue Scale(VAS SCALE).
      
Patient satisfaction and use of other analgesics in post operative period will also be compared alongside.
 
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