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CTRI Number  CTRI/2024/03/063615 [Registered on: 05/03/2024] Trial Registered Prospectively
Last Modified On: 02/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare external oblique intercostal fascial plane block and erector spinae plane block in patients undergoing open abdominal surgeries by assessing pain after surgery  
Scientific Title of Study   Comparison of analgesic efficacy of ultrasound guided External oblique Intercostal fascial Plane (EOI) Block versus Erector Spinae Plane (ESP) Block in adult patients undergoing open upper abdominal surgeries: 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  Angad Maurya 
Designation  Anaesthesia Academic Junior Resident 
Affiliation  All India Institute of Medical Sciences, Patna 
Address  Department of Anesthesiology,Room no. 307, Hostel - 1,Aiims patna, Phulwari Sharif ,Patna 801507, Bihar, India

Patna
BIHAR
801507
India 
Phone  7739099932  
Fax    
Email  angadmaurya9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Chandni Sinha 
Designation  Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anesthesiology AIIMS Patna

Patna
BIHAR
801507
India 
Phone  7250333148  
Fax    
Email  chandni.doc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Chandni Sinha 
Designation  Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anesthesiology aiims 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,Patna,Phulwari Sharif,Patna,Bihar,801507, India. 
 
Primary Sponsor  
Name  Aiims Patna 
Address  Department of Anesthesiology Aiims Patna 
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 Angad Maurya  All India Institute Of Medical Sciences  Department of Anaesthesia, 5th floor, ot complex, ipd bulding, AIIMS Patna
Patna
BIHAR 
7739099932

angadmaurya9@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  Erector Spinae plane block   25 ml 0.2 % ropivacaine in erector spinae plane alone single shot prior to surgery 
Intervention  External oblique intercostal plane block and erector spinae plane block   25 ml of 0.2 % ropivacaine in each external oblique intercostal plane and erector spinae plane single shot prior to surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Adult patients 18 -75 years,
American Society of Anesthesiologists-physical status (ASA-PS) I–II undergoing open
upper abdominal surgery with Unilateral Subcostal incision
Patients willing to give written informed consent 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess and compare 24-hour postoperative opioid consumption in ESP block group and
EOI block group via numerical rating scale (NRS) 
To assess and compare 24-hour postoperative opioid consumption in ESP block group and
EOI block group via numerical rating scale (NRS) at 30 minutes, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours and 24 hours.  
 
Secondary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia.
Numerical rating scores of pain (rest and cough) in first 24-hour postoperative period
Total intraoperative opioid consumption
Postoperative opioid consumption
 
From the time of administration of block to first need of use of analgesic administration
30 mins, 2,4,8,12,16,24 hours.
from the time of administration of block to end of surgery
at 4, 8, 12, 16 hours
 
 
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)   17/03/2024 
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="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   This is randomized controlled study to compare analgesic efficacy of external oblique intercostal plane block and erector spinae plane block in adult patients undergoing open upper abdominal surgery using ultrasound machine. 
Primary objective of this study to assess and compare 24-hour postoperative opioid consumption in External oblique intercostal plane block group and Erector spinae plane block  group.
 

All patients will be recruited one day prior to surgery and a detailed pre anaesthetic assessment will be done. The patients will be instructed to stay nil per oral (NPO) according to standard fasting guidelines prior to surgery.
After shifting the patients to operating room standard ASA monitors will be attached and baseline vitals like heart rate (HR), noninvasive blood pressure (NIBP), Electrocardiogram (ECG), oxygen
saturation (SpO2), and temperature will be monitored. General anaesthesia (GA) will be given using intravenous Fentanyl 2 μg/kg, Propofol 2 mg/kg and Atracurium 0.5 mg/kg. Paracetamol 15
mg/kg and Dexamethasone 6 mg IV would be administered to all patients.
An anesthesiologist with expertise executing blocks who has performed minimum 25 such blocks (who will be blinded to the collected data until the end of the trial) will perform the block
procedures. Both blocks will be done under strict aseptic conditions with ultrasound machines equipped with a high-frequency linear probe with a sterile sheath 
Group A will receive US - guided External oblique intercostal plane block using 25 ml of 0.2% Ropivacaine along with GA. 
Group B: will receive US-guided Erector Spinae plane block External oblique intercostal plane block using 25 ml of 0.2% Ropivacaine at T7 level along with GA.
Time of block performance(TBP) will be observed in each group. 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.
Anesthesia will be maintained with sevoflurane, oxygen and air with a target MAC of 1. Skin incision will be allowed 15 minutes after the injection of study solutions in both the groups.
Intraoperative any increase in HR/MAP more than 20% intraoperatively will be treated with
additional fentanyl doses of 0.5 mcg/kg. Total intraoperative fentanyl consumption will be noted in both groups. Intraoperatively MAP and HR will be recorded at 5, 30, 60, and 90 minutes afterskin incision and at the end of surgery. No local anesthetic will be used by the surgeon for infiltration in either of the groups.
At the end of surgery, all the patients will receive Injection Ondansetron 0.1mg/kg and reversal agent (Injection neostigmine 0.05mg/kg and injection glycopyrrolate 0.01mg/kg). The patient will
be shifted to the post anesthesia care unit (PACU) with oxygen supplementation by mask as per requirements. Postoperatively all patients will receive 15 mg/kg IV paracetamol every 6 hours.
Pain perception will be measured in the PACU at rest by using NRS (0–10) at 30 minutes, 2,4,8,12,16 and 24 hour
All patients enrolled in the study will be given a patient controlled analgesia (PCA) pump programmed for a demand-only mode with no basal rate; the program will deliver a bolus of fentanyl 25 micg with a maximum of 6 doses in an hour.
This study include adult patients age between 18- 75 years.  The calculated sample size is 50. Expected duration of surgery 1.5 years


 
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