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CTRI Number  CTRI/2025/09/094554 [Registered on: 10/09/2025] Trial Registered Prospectively
Last Modified On: 09/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of a nerve block and injection at the surgical site for managing pain after gallbladder removal surgery. 
Scientific Title of Study   Comparative evaluation of analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia. 
Trial Acronym  No 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Samiksha Kalra 
Designation  PG Student 
Affiliation  ESIC Medical College and Hospital Faridabad 
Address  Department of Anaesthesiology ESIC Medical College and Hospital Faridabad

Faridabad
HARYANA
121001
India 
Phone  9034525606  
Fax    
Email  drsamikshakalra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Virmani 
Designation  Professor & Head 
Affiliation  ESIC Medical College and Hospital Faridabad 
Address  Department of Anaesthesiology ESIC Medical College and Hospital Faridabad

Faridabad
HARYANA
121001
India 
Phone  9654958719  
Fax    
Email  rashmi.virmani@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Niharika Grover 
Designation  Assistant Professor 
Affiliation  ESIC Medical College and Hospital Faridabad 
Address  Department of Anaesthesiology ESIC Medical College and Hospital Faridabad

Faridabad
HARYANA
121001
India 
Phone  9811632907  
Fax    
Email  drniharikagroverss@gmail.com  
 
Source of Monetary or Material Support  
ESIC Medical College and Hospital Faridabad 121001 Haryana  
 
Primary Sponsor  
Name  Dr Samiksha Kalra 
Address  Department of Anaesthesiology ESIC Medical College and Hospital Faridabad 121001  
Type of Sponsor  Other [Self] 
 
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 Samiksha Kalra  ESIC Medical College and Hospital Faridabad   Department of Anaesthesiology ESIC Medical College and Hospital Faridabad 121001
Faridabad
HARYANA 		 9034525606

drsamikshakalra@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ESIC Medical College & Hospital Faridabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K80||Cholelithiasis, (2) ICD-10 Condition: K81||Cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Port site infiltration  Local infiltration at port site using 20 ml of 0.20% ropivacaine after induction of anaesthesia and before incision. Duration of effect to be observed till 24 hours postoperatively. 
Intervention  Ultrasound-guided External oblique intercostal plane block   Right sided External Oblique intercotal plane block using 20 ml of 0.20% ropivacaine after induction of anaesthesia and before incision. Duration of effect to be observed till 24 hours postoperatively. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Patients belonging to American Society of Anaesthesiologists (ASA) physical status I or II
2 Body mass index 18 to 30 kg/m²
3 Patients undergoing elective laparoscopic cholecystectomy under general anaesthesia 
 
ExclusionCriteria 
Details  1. History of allergy or hypersensitivity to local anaesthetics
2. Infection at the site of needle insertion
3. Pregnant or lactating females
4. Patients with history of narcotic or alcohol addiction
5. Coagulopathy
6. Psychiatric disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Time of first rescue analgesia post operatively  Time of first rescue analgesia within first 24 hours post operatively  
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic Parameters   intraoperatively at 5,30,60 and 90 minutes and at end of surgery
postoperatively at 1, 6 and 24 hours 
Intraoperative fentanyl requirement (in micrograms)   
Numerical rating scale for postoperative pain   at rest, deep breathing (1,6,24 hours)
at movement (24 hours)  
Total rescue analgesic requirement in first 24 hours   
Incidence of postoperative nausea and vomitting in first 24 hours postoperatively   
 
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)   01/10/2025 
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 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  
Study Title: Comparative evaluation of analgesic efficacy of ultrasound guided external oblique intercostal plane block versus port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

Study Type: Interventional, Randomized, Double-Blind, Parallel comparative study

Objective:   To compare the analgesic efficacy of ultrasound guided unilateral external oblique intercostal plane block versus local port site infiltration in patients undergoing laparoscopic cholecystectomy under general anaesthesia.

Participants: Adult patients aged 18–65 years, ASA physical status I–II, body mass index 18 - 30 kg/m² scheduled for elective laparoscopic cholecystectomy under general anaesthesia.

Interventions:

  • Group A: Patients will receive right sided ultrasound- guided external oblique intercostal plane block using 20 ml of 0.20% ropivacaine after induction of anaesthesia

  • Group B: Patients will receive local infiltration at port site using 20 ml of 0.20% ropivacaine after induction of anaesthesia.

Primary Outcome: To evaluate and compare time to first rescue analgesia postoperatively

Secondary Outcomes:

  •   Hemodynamic parameters intraoperatively at  5, 30, 60, 90 minutes, at the end of surgery and postoperatively at 1, 6, 24 hours
  •   Intraoperative fentanyl (microgram) requirement
  •   Postoperative Numerical Rating Scale (NRS) score for pain at rest, deep breathing at 1, 6, 24 hours and on movement at 24 hours
  •   Total rescue analgesic requirement in first 24 hours
  •   Patient’s satisfaction score at 6 hours postoperatively
  •   Incidence of postoperative nausea and vomiting (PONV) in first 24 hours
Sample Size:  50 patients (25 per group) .
Rationale: EOIPB is a newer interfascial analgesic technique that anaesthetise lateral as well as anterior cutaneous branches of T6–T10 intercostal nerves and provides better outcomes in reducing postoperative pain and opioid consumption in post laparoscopic cholecystectomy patients. 


 
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