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CTRI Number  CTRI/2025/09/094886 [Registered on: 16/09/2025] Trial Registered Prospectively
Last Modified On: 13/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of ultrasound guided back muscle plane block and incision site infiltration for reducing pain in Laparoscopic gall-bladder removal operation 
Scientific Title of Study   Comparison of analgesic efficacy of ultrasound guided erector spinae plane block with port site infiltration in laparoscopic cholecystectomy: A SINGLE BLIND 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  Nairita Mayur 
Designation  Assistant Professor 
Affiliation  College of Medicine & Sagore Dutta Hospital 
Address  Dept of Anesthesiology, Assistant Professor, 1st floor, Main OT complex, College of Medicine and Sagore Dutta Hospital, Kamarhati
Kamarhati
Kolkata
WEST BENGAL
700058
India 
Phone  9474862764  
Fax    
Email  nairitalive@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Nairita Mayur 
Designation  Assistant Professor 
Affiliation  College of Medicine & Sagore Dutta Hospital 
Address  Dept of Anesthesiology, Assistant Professor, 1st floor, Main OT complex, College of Medicine and Sagore Dutta Hospital, Kamarhati
Kamarhati
Kolkata
WEST BENGAL
700094
India 
Phone  9474862764  
Fax    
Email  nairitalive@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Nairita Mayur 
Designation  Assistant Professor 
Affiliation  College of Medicine & Sagore Dutta Hospital 
Address  Dept of Anesthesiology, Assistant Professor, 1st floor, Main OT complex, College of Medicine and Sagore Dutta Hospital, Kamarhati
Kamarhati
Kolkata
WEST BENGAL
700094
India 
Phone  9474862764  
Fax    
Email  nairitalive@gmail.com  
 
Source of Monetary or Material Support  
College of Medicine & Sagore Dutta Hospital, Dept of Anesthesiology, Assistant Professor, 1st floor, Main OT complex, College of Medicine and Sagore Dutta Hospital, Kamarhati, Kolkata 
 
Primary Sponsor  
Name  Govt Medical College 
Address  Dept of Anesthesiology, Assistant Professor, 1st floor, Main OT complex, College of Medicine and Sagore Dutta Hospital, Kamarhati 
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 Nairita Mayur  College of Medicine and Sagore Dutta Hospital  Dept of Anesthesiology, Assistant Professor, 1st floor, Main OT complex, College of Medicine and Sagore Dutta Hospital, Kamarhati
Kolkata
WEST BENGAL 
9474862764

nairitalive@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, College of Medicine and Sagore Dutta Hospital, Kamarhati Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K810||Acute cholecystitis, (2) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (3) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (4) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (5) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comparison of analgesic efficacy of ultrasound guided erector spinae plane block with port site infiltration in laparoscopic cholecystectomy  Comparison of analgesic efficacy of ultrasound guided erector spinae plane block with port site infiltration in laparoscopic cholecystectomy: A SINGLE BLIND randomized controlled trial. Total duration for the block is approx 15 minutes 
Comparator Agent  Comparison of analgesic efficacy of ultrasound guided erector spinae plane block with port site infiltration in laparoscopic cholecystectomy  Comparison of analgesic efficacy of ultrasound guided erector spinae plane block with port site infiltration in laparoscopic cholecystectomy: A SINGLE BLIND randomized controlled trial. Total duration for the block is approx 5-10 minutes 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  a. American Society of Anesthesiologists Physical Status I and II
b. Age between 18 and 60 years old undergoing laparoscopic cholecystectomy 
 
ExclusionCriteria 
Details  a. refusal for regional anaesthesia
b. patient having infection at site of injection
c. patients having coagulopathy and platelet count less than 1 lakh per cmm
d. patients with a known allergy to local anaesthetics.
e. pregnancy,
f. body mass index more than 35 kg per m2,
g. chronic pain
h. hepatic or renal dysfunction( Srerum creatinine more than 1.2 ;liver enzymes exceeding normal limit)
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
a. Hemodynamic profile (heart rate and mean blood pressure) in the intraoperative period
b. Mean total dose of fentanyl during the intraoperative period during laparoscopic cholecystectomy
c. Time to requirement of first rescue analgesic (inj Diclofenac 75mg iv) when VAS score more than 4.
 
Intra-operatively every 10 minutes and post-operatively every 30 minutes till the patient is shifted to the ward and then every hourly for the next 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   01/12/2025 
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="0"
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  

Laparoscopic cholecystectomy is the standard treatment for gallstone disease, yet many patients still experience moderate-to-severe postoperative pain. Opioid-based analgesia, though effective, is limited by side effects such as respiratory depression, nausea, vomiting, and delayed recovery, making multimodal, opioid-sparing strategies preferable. The erector spinae plane block (ESPB), first described in 2016, has shown promising results in thoracic and upper abdominal surgeries, but evidence in laparoscopic cholecystectomy remains limited. This randomized controlled trial aims to evaluate the analgesic efficacy of ESPB combined with port-site infiltration compared with port-site infiltration alone in adult patients undergoing laparoscopic cholecystectomy. Patients will be randomly assigned to receive either ultrasound-guided ESPB at the T7–T8 level with port-site infiltration or port-site infiltration alone, with standardized general anesthesia and non-opioid analgesia in both groups. The primary outcome is the time to first rescue analgesia within 24 hours, with intraoperative fentanyl consumption as a key secondary outcome. Additional endpoints include postoperative opioid use, pain scores, incidence of postoperative nausea and vomiting, recovery quality, and block-related complications. Approximately ninety-two patients will be enrolled to detect a clinically significant difference with adequate power. By assessing whether ESPB can reduce perioperative opioid requirements and prolong postoperative analgesia, this study seeks to establish its role in enhancing multimodal pain management for laparoscopic cholecystectomy. Our research hypothesis will be Ultrasound guided erector spinae block may reduce the requirement of intraoperative fentanyl consumption and increase the time of 1st rescue analgesic dose.

 
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