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CTRI Number  CTRI/2024/05/067956 [Registered on: 27/05/2024] Trial Registered Prospectively
Last Modified On: 23/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Different technique of post operative pain relief after shoulder surgery 
Scientific Title of Study   Comparison of Erector Spinae Plane Block at the Level of Second Thoracic Vertebrae with Interscalene Block for Postoperative Analgesia in Arthroscopic Shoulder Surgery: A Randomized Controlled 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 Pramila Soni 
Designation  Associate Professor 
Affiliation  Dr.SN Medical College 
Address  Dr. SN Medical College , Department of Anaesthesiology, Sector-D,Shastri Nagar,Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  94686940551  
Fax    
Email  drpramila82@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vivek Soni 
Designation  PG student 
Affiliation  Dr.SN Medical College 
Address  Dr. SN Medical College , Department of Anaesthesiology, Sector-D,Shastri Nagar,Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  7300030041  
Fax    
Email  vikusoni97@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vivek Soni 
Designation  PG student 
Affiliation  Dr.SN Medical College 
Address  Dr. SN Medical College , Department of Anaesthesiology, Sector-D,Shastri Nagar,Jodhpur

Jodhpur
RAJASTHAN
342003
India 
Phone  7300030041  
Fax    
Email  vikusoni97@gmail.com  
 
Source of Monetary or Material Support  
RRC Operation Theatre 1st Floor ,Department of Anaesthesia Mahatma Gandhi Hospital ,Dr.Sampurnanand medical college,Jodhpur, Rajasthan, 342001 
 
Primary Sponsor  
Name  Dr. SN Medical College 
Address  Residency Rd, Sector-D,Shastri Nagar,Jodhpur,Rajasthan 342003 
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 
Dr Vivek Soni  MGH Hospital  Department of Anaesthesiology, RRC OT 1st floor ,near railway station road, Jodhpur ,Rajasthan
Jodhpur
RAJASTHAN 		 7300030041

vikusoni97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S460||Injury of muscle(s) and tendon(s)of the rotator cuff of shoulder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ESPB(Erector Spinae Plane Block)  0.5% 20 ml Ropivacaine  
Comparator Agent  ISB (Intersclanae block)  0.5% 20 ml Ropivacaine  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  The patients aged 18 to 65 years of either gender of either ASA category I or II, scheduled for elective unilateral shoulder arthroscopic surgery 
 
ExclusionCriteria 
Details  1- Refusal to participate in study,
2- Allergy/sensitivity to local anaesthetics (LAs) and/or opioids,
3-Infection at the procedure site (ESPB and ISB sides, corresponding to the T2 level and the neck, respectively),
4-Patient with deranged coagulation profile[ PT /INR]
5- Patient receiving Anticoagulant and Antiplatelet therapy [ Aspirin / Clopidogrel/ iv anticoagulant]
6- Pregnancy or suspected pregnancy[UPT], breastfeeding mother
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare Numerical rating score (NRS)  24 hrs.
 
 
Secondary Outcome  
Outcome  TimePoints 
Cumulative dose of rescue analgesia in 24 hour  24 hrs. 
Time to 1st rescue analgesics in both groups  24 hrs. 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   03/06/2024 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vikusoni97@gmail.com].

  6. For how long will this data be available start date provided 30-05-2024 and end date provided 30-05-2029?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Arthroscopic surgery have allowed surgeons to perform day care surgeries including shoulder surgery .About 54% of these patient experience severe post pain.  Interscalene brachial plexus block(ISB) is gold standard technique for shoulder analgesia but its use is offset by high rate of hemi-diaphragmatic paralysis which can be very critical in patient with preexisting pulmonary pathology.Therefore, phrenic nerve sparing block have been subject of study ane among which is Erector Spinae plane Block(ESPB). In our study we are studying does Ultrasound guided ESPB has better post operative analgesia than ISB in patient undergoing shoulder arthroscopic surgery. 
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