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CTRI Number  CTRI/2023/02/050011 [Registered on: 23/02/2023] Trial Registered Prospectively
Last Modified On: 21/02/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the comparison of two different nerve blocks for pain relief in patients undergoing upper abdominal surgery 
Scientific Title of Study   Comparison of ultrasound guided External Oblique Intercostal Plane Block and Subcostal Transversus Abdominis Plane Block in patients undergoing upper abdominal surgery: A randomized clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Chandni Sinha 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Dept of Anesthesia. Room no. 2 B5A New OT Complex IPD building AIIMS Patna, Phulwarisharif Patna

Patna
BIHAR
801507
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chandni Sinha 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Dept of Anesthesia. Room no. 2 B5A New OT Complex IPD building AIIMS Patna, Phulwarisharif Patna

Patna
BIHAR
801507
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chandni Sinha 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences,Patna 
Address  Dept of Anesthesia. Room no. 2 B5A New OT Complex IPD building AIIMS Patna, Phulwarisharif Patna

Patna
BIHAR
801507
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Source of Monetary or Material Support  
All India Institute Of Medical Sciences, Phulwarisharif , Patna-801507 Bihar 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences, Patna 
Address  All India Institute of Medical Sciences, Patna Phulwarisharif Patna-801507 
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 Chandni Sinha  All India Institute of Medical Sciences, Patna  Dept of Anesthesia. Room no. 2, B5A, New OT Complex, IPD building, AIIMS Patna Phulwarisharif
Patna
BIHAR 
7250333148

chandni.doc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Patna  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  Ultrasound guided subcostal transversus abdominis plane block  The US probe will be placed immediately below the costal margin in an oblique plane close to midline to identify the rectus abdominis muscle. The transversus abdominis muscle will be identified lying posterior to the rectus muscle. An 8cm 22-gauge block needle will be inserted using an in- plane approach. Transversus abdominis plane will be accessed by placing the needle adjacent to costal margin but medial to linea semilunaris. The needle will be advanced slowly in-plane to promote hydrodissection. A volume of 25ml 0.2% Ropivacaine will be injected.  
Intervention  Ultrasounded guided external oblique intercostal plane block  After induction of general anaesthesia patients in group E will receive ultrasound guided External Oblique Intercostal Plane block. With patient in supine position high frequency linear transducer will be placed in the sagittal plane between midclavicular and anterior axillary line at the level of 6th rib. After optimization of image, 8cm 22-gauge block needle will be inserted from superomedial to inferolateral direction through the external oblique muscle. 25ml of 0.2% Ropivacaine will be deposited between the external oblique and intercostal muscle at the caudal end of the 6th rib.Time of block performance(TBP) will be observed. The TBP will be accepted as the time from the placement of the US probe on the skin to the administration of the injection and will be recorded by the anesthesia technician. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA I –II patients scheduled to undergo elective supra-umbilical surgeries with unilateral
incision under GA
 
 
ExclusionCriteria 
Details  1. BMI< 20
2. Allergy to local anesthetics
3. Infection at the site of injection
4. Chronic pain syndromes
5. Patients on chronic analgesic therapy
6. Chronic liver disease, chronic renal disease, and cognitive impairment
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time to first rescue analgesic administration  Time to first rescue analgesic administration 
 
Secondary Outcome  
Outcome  TimePoints 
Time of block performance (TBP)
Intraoperative fentanyl consumption
Amount of postoperative Fentanyl consumption in first 24 hours
Postoperative pain score evaluated by NRS at 0,1,2,4, 6, 12 and 24 hrs.
Complications
 
0,1,2,4, 6, 12 and 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   N/A 
Date of First Enrollment (India)   01/03/2023 
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   nil 
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 (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) - 

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-12-2023 and end date provided 31-12-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   This is a clinical trial to compare the analgesic efficacy of ultrasound guided External Oblique Intercostal Plane Block better and Subcostal Transversus Abdominis Plane Block in patients undergoing upper abdominal surgery. Group E will receive US-guided External Oblique Intercostal Plane block using 25ml of 0.2% Ropivacaine along with GA and Group T will receive US-guided Subcostal TAP block using 25ml of 0.2% Ropivacaine along with GA. Total  intraoperative fentanyl consumption will be noted in both groups. Time of block performance(TBP) will be observed in each group. Pain perception will be measured in the PACU at rest by using NRS (0–10) at 0,1,2,4,6,12, and 24 hour, total opioid consumption will be recorded and complications if any will be noted 
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