| 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
|
|
|
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
|
|
|
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. |