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CTRI Number  CTRI/2025/01/079280 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing effects of two doses of a medicine dexmedetomidine on nerve block to relieve pain in people undergoing surgery of upper part of abdomen  
Scientific Title of Study   Comparison of two doses of dexmedetomidine as adjuvants in external oblique intercostal block (EOIB) on postoperative analgesia in laparoscopic upper abdominal surgeries. a double blinded randomised 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 Aditi Suri  
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences  
Address  Anaesthesia department office Room 5010 5th floor Main building

South
DELHI
110024
India 
Phone  8800798097  
Fax    
Email  aditisuri19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aditi Suri  
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences  
Address  Anaesthesia Department office Room 5010 5th floor Main building


DELHI
110024
India 
Phone  8800798097  
Fax    
Email  aditisuri19@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Suri  
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences  
Address  Anaesthesia department office Room 5010 5th floor Main building


DELHI
110024
India 
Phone  8800798097  
Fax    
Email  aditisuri19@gmail.com  
 
Source of Monetary or Material Support  
Room 5010 Department of anaesthesia 5th floor Main building AIIMS Ansari Nagar New Delhi - 110024 India 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences 
Address  Room 5010 Department of anaesthesia 5th floor Main building AIIMS Ansari Nagar New Delhi - 110024 India 
Type of Sponsor  Research institution 
 
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 Aditi Suri  All India Institute of Medical Sciences  6th floor Operation theatre complex Surgical block AIIMS South DELHI
South
DELHI 		 8800798097

aditisuri19@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE, ALL INDIAA INSTITUTE OF MEDICAL SCIENCES  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  External oblique intercostal block with Dexmedetomidine 0.5 mcg/kg  USG guided single shot External oblique intercostal block to be perfomed in the fascial plane between external oblique and inercostal muscle with injection of 25 ml of 0.25% ropivacaine on each side with 0.5 mcg/kg of dexmedetomidine in total 
Intervention  External oblique intercostal block with Dexmedetomidine 1mcg/kg  USG guided single shot External oblique intercostal block to be perfomed in the fascial plane between external oblique and inercostal muscle with injection of 25 ml of 0.25% ropivacaine on each side with 1.0 mcg/kg of dexmedetomidine in total 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  a) Age 18 to 70 years old
b) American Society of Anesthesiology (ASA ) class 1 and 2
c) Patients undergoing laparoscopic upper abdominal surgeries 
 
ExclusionCriteria 
Details  a) Patients who deny consent
b) Presence of local infection
c) Local anaesthetic allergy  
 
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 
Fentanyl consumption  Fentanyl consumption at 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1. Pain score as measured by numerical rating scale
2. Postoperative nausea vomiting
3. Ramsay sedation score  		 1. Pain assessed immediately postoperatively, at 2 hours, 12 hours, 24 hours.

2. PONV assessed at immediate postoperatively & at 24 hours

3. Sedation assessed immediate postoperative & at 2 hours

4. Adverse events like bradycardia, hypotension at insufflation and in intraoperative period 
 
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)   05/02/2025 
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="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   Upper abdominal surgeries are associated with severe pain. Neuraxial blocks are gold standard but are not feasible in all patients. External oblique intercostaal block (EOIB) provides analgesia from T6-T10 dermatomes. It is easy to administer, even in obese patients, injection is away from surgical field. Previous literature on this block exists in the form of case series, reports and a single randomised study on laparoscopic cholecystectomy. Dexmedetomidine acts as an adjuvant improves the analgesic efficacy of perineural blocks.  No previous studies have used dexmedetomidine in external oblique intercostal block.

 We therefore aim to assess the analgesic efficacy of two doses of dexmedetomidine as adjuvant to external oblique intercostal block in laparoscopic surgeries.
Both intervention and control groups in this sstudy will be provided adequate intraoperative analgesia using fentanyl boluses and postoperative analgesia using fentanyl iv patient controlled analgesia (PCA). Total consumption of fentanyl will be noted for both groups at 24 hours postoperatively. 
 
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