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CTRI Number  CTRI/2025/07/090851 [Registered on: 14/07/2025] Trial Registered Prospectively
Last Modified On: 12/07/2025
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 Two Ultrasound Guided Nerve Blocks for Postoperative Analgesia in Patients Undergoing Upper Abdominal Surgery Under General Anaesthesia 
Scientific Title of Study   Comparison of ultrasound guided External Oblique Intercostal plane block and Transversus Abdominis plane block for postoperative analgesia in patients undergoing upper abdominal surgery under general anaesthesia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Naoshad Baqir 
Designation  Post Graduate Student 
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi 
Address  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001 India New Delhi

Central
DELHI
110001
India 
Phone  9622207588  
Fax    
Email  baqir.naoshad7@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Itishri 
Designation  Associate professor  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi 
Address  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001

Central
DELHI
110001
India 
Phone  9212400570  
Fax    
Email  itianesthesia@gmail.com  
 
Details of Contact Person
Public Query  
Name  Itishri 
Designation  Associate professor  
Affiliation  ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi 
Address  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001

Central
DELHI
110001
India 
Phone  9212400570  
Fax    
Email  itianesthesia@gmail.com  
 
Source of Monetary or Material Support  
ABVIMS and Dr. Ram Manohar Lohia Hospital, Baba Kharak Singh Marg, Near Gurudwara Bangla Sahib, Connaught Place, New Delhi, Delhi 110001 Central DELHI 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Naoshad Baqir  ABVIMS and Dr. Ram Manohar Lohia Hospital  Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND DR. RML HOSPITAL Central DELHI 110001
Central
DELHI 		 9622207588

baqir.naoshad7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ABVIMS and Dr. RML Hospital, New Delhi  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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison of ultrasound guided external oblique intercostal plane block vs transversus abdominis plane block.  Comparison of ultrasound guided external oblique intercostal plane block vs transversus abdominis plane block for upper abdominal surgeries under general anesthesia. 
Intervention  NIL  NIL 
Comparator Agent  Ultrasound guided external oblique intercostal plane block  Patients will receive 20 mL 0.125% bupivacaine with additive inj Fentanyl 2mcg/kg postoperatively 
Comparator Agent  Ultrasound guided transversus abdominis plane block  Patients will receive 20 mL 0.125% bupivacaine with additive inj Fentanyl 2mcg/kg postoperatively and will be compared with other group 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  ASA grade 1 and 2 .
Elective upper abdominal surgeries . 
 
ExclusionCriteria 
Details  Known allergy to local anaesthetics.
Infection at injection site.
Patients undergoing chronic analgesia therapy.
Laparoscopic surgeries.
Patients with BMI more than 30. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Total 24 hour injection tramadol consumption  5 minutes, 30 minutes, 1 hour, 6 hours, 12 hours, and 24 hours after intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia postoperatively.
Patient satisfaction based on Likert scale (0-5). 		 24 hours after intervention. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/08/2025 
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="6"
Days="0" 
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  

After preanaesthetic evaluation and obtaining written informed consent, patients will

be randomised by computer generated numbers into two groups.

Group E: Patients receiving External Oblique Intercostal Plane Block.

Group T: Patients receiving Transversus Abdominis Plane Block.

Patients in each group will receive 20 mL 0.125% bupivacaine with additive inj Fentanyl

2mcg/kg postoperatively. The patient will be shifted to operation theatre. Standard monitors

will be attached (noninvasive B.P, ECG, pulse oximetry, temperature probe) to record the

baseline vitals which will be monitored all through the procedure.

After obtaining wide bore intravenous access. Following injection Midaz 1.0 mg i/v,

injection Fentanyl 2.0 mcg/kg i.v., and injection propofol 2.0 mg/kg; check ventilation will be

done, and muscle relaxation will be attained using injection Vecuronium 0.1 mg/kg followed

by tracheal intubation with appropriate size endotracheal tube and put on mechanical

ventilation. Anaesthesia will be maintained with air, oxygen and sevoflurane with a MAC of

1-1.2

Vital signs ; HR, SBP, DBP, MAP, SpO2 will be recorded.

Injection fentanyl 1.0 mcg/kg will be administered if HR or MAP rise more than 20% of

baseline

Patients will receive injection paracetamol 15mg/kg after induction of anesthesia and 6

hourly till 24 hours after surgery

At the end of surgery respective ultrasound guided block will be given by an experienced

anaesthesiologist according to the study group allotted.

Injection ondansetron 0.1 mg/kg will be administered, and patient will be reversed

with injection neostigmine (0.05mg/kg) and injection glycopyrollate (0.01mg/kg).

Postoperatively HR, SBP, DBP, MAP and SpO2 heart rate, systolic blood pressure, diastolic

blood pressure, mean arterial pressure, SpO2, and NRS score (on scale of 1-10) will be

recorded at 5 min, 30 min, 60 min, 6hr, 12hr and 24 hr postoperatively by the anaesthesiologist

blinded to the group allotted.

Patients will be administered injection tramadol 50mg if NRS score is more than or equal to 4


 
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