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CTRI Number  CTRI/2026/03/105488 [Registered on: 06/03/2026] Trial Registered Prospectively
Last Modified On: 06/03/2026
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 erector spinae plane block and standard pain treatment for reducing pain after laparoscopic gallbladder surgery in adult patients 
Scientific Title of Study   Randomized controlled trial comparing the analgesic efficacy of erector spinae plane block versus standard analgesia protocol in laparoscopic cholecystectomy under general anaesthesia 
Trial Acronym  ESPLAP Trial 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rahul Gawas 
Designation  DNB Resident Anaesthesiology 
Affiliation  Dr Babasaheb Ambedkar Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care, Dr Babasaheb Ambedkar Medical College and Hospital, Sector 6 Rohini

North West
DELHI
110085
India 
Phone  9028219404  
Fax    
Email  gawas.rahul27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Vandana Chugh 
Designation  Professor And Head Of The Department 
Affiliation  Dr Babasaheb Ambedkar Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care, Dr Babasaheb Ambedkar Medical College and Hospital, Sector 6 Rohini

North West
DELHI
110085
India 
Phone  7290095540  
Fax    
Email  deepakvandana786@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Vandana Chugh 
Designation  Professor And Head Of The Department 
Affiliation  Dr Babasaheb Ambedkar Medical College and Hospital 
Address  Department of Anaesthesiology and Critical Care, Dr Babasaheb Ambedkar Medical College and Hospital, Sector 6 Rohini

South West
DELHI
110085
India 
Phone  7290095540  
Fax    
Email  deepakvandana786@yahoo.co.in  
 
Source of Monetary or Material Support  
Self funded 
 
Primary Sponsor  
Name  Dr Babasaheb Ambedkar Medical College and Hospital 
Address  Dr Babasaheb Ambedkar Medical College and Hospital Sector 6 Rohini New Delhi 110085 
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 Rahul Gawas  Dr Babasaheb Ambedkar Medical College and Hospital  Department of Anaesthesiology and Critical Care Operation Theatre Complex Dr Babasaheb Ambedkar Medical College and Hospital Sector 6 Rohini New Delhi 110085
North West
DELHI 		 9028219404

gawas.rahul27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Dr Babasaheb Ambedkar Medical College and Hospital  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 
Intervention  Erector spinae plane block  Bilateral erector spinae plane block with 20 ml of 0 point 25 percent bupivacaine and 2 mg dexamethasone on each side given before induction of general anaesthesia 
Comparator Agent  Standard analgesia protocol  Intravenous diclofenac 75 mg twice daily and intravenous paracetamol 500 mg three times daily postoperatively with tramadol 100 mg as rescue analgesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients aged 18 to 60 years with ASA physical status one or two undergoing elective laparoscopic cholecystectomy 
 
ExclusionCriteria 
Details  Allergy to local anaesthetics, coagulopathy or patients on anticoagulant therapy, infection at injection site, body mass index more than 35 kilogram per meter square, chronic pain syndromes, opioid dependence 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Postoperative pain score measured using visual analogue scale and total opioid consumption in first 24 hours  Postoperative pain score measured using visual analogue scale and total opioid consumption in first 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of postoperative nausea and vomiting  0 to 3 hours and 3 to 24 hours postoperatively 
Time to first rescue analgesia  Within 24 hours postoperatively 
Patient satisfaction using Likert scale  At 24 hours postoperatively 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   20/03/2026 
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 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   This randomized controlled trial aims to compare the analgesic efficacy of bilateral erector spinae plane block with standard analgesia protocol in patients undergoing elective laparoscopic cholecystectomy under general anaesthesia. Ninety patients aged 18 to 60 years with ASA physical status one or two will be randomly allocated into two groups. The intervention group will receive bilateral erector spinae plane block with 20 ml of 0 point 25 percent bupivacaine and 2 mg dexamethasone on each side before induction of general anaesthesia. The control group will receive standard postoperative analgesia consisting of intravenous diclofenac and paracetamol with tramadol as rescue analgesia. Postoperative pain will be assessed using visual analogue scale at predefined time intervals up to 24 hours. Total opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting and patient satisfaction will also be evaluated. The study aims to determine whether erector spinae plane block provides superior postoperative analgesia and reduces opioid requirement compared to standard analgesia protocol. 
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