| CTRI Number |
CTRI/2025/09/093995 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparing Two Pain Relief Methods After Gallbladder Surgery: A Study on Ultrasound-Guided nerve Block vs Traditional Techniques |
|
Scientific Title of Study
|
Comparative study of ultrasound-guided Erector Spinae Plane block versus Conventional technique for post-operative analgesia after Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka G |
| Designation |
Assistant Professor |
| Affiliation |
RajRajeswari medical college and hospital |
| Address |
Department of Anaesthesia, Rajarajeswari medical college and Hospital, Mysore road, Kambipura, Bangalore
RajaRajeswari Medical college and hospital,202,Mysore road,kambipura, karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
07795439546 |
| Fax |
|
| Email |
drpriyanka2405@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka G |
| Designation |
Assistant Professor |
| Affiliation |
RajRajeswari medical college and hospital |
| Address |
Department of Anaesthesia, Rajarajeswari medical college and Hospital, Mysore road, Kambipura, Bangalore
RajaRajeswari Medical college and hospital,202,Mysore road,kambipura, karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
07795439546 |
| Fax |
|
| Email |
drpriyanka2405@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka G |
| Designation |
Assistant Professor |
| Affiliation |
RajRajeswari medical college and hospital |
| Address |
Department of Anaesthesia, Rajarajeswari medical college and Hospital, Mysore road, Kambipura, Bangalore
RajaRajeswari Medical college and hospital,202,Mysore road,kambipura, karnataka
Bangalore
KARNATAKA
560074
India |
| Phone |
07795439546 |
| Fax |
|
| Email |
drpriyanka2405@gmail.com |
|
|
Source of Monetary or Material Support
|
| RajaRajeswari medical college and hospital |
|
|
Primary Sponsor
|
| Name |
RajaRajeswari Medical college and hospital, |
| Address |
202,Mysore road,kambipura, karnataka |
| Type of Sponsor |
Private 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 |
| Priyanka G |
Rajarajeswari medical college and hospital |
2nd floor OT complex ,Department of anaesthesia
Bangalore
KARNATAKA |
07795439546
drpriyanka2405@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajrajeswari medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (2) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (3) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (4) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
Erector spinae plane block involves the injection of a local anaesthetic between the erector spinae muscle and the transverse process of the vertebra in order to block dorsal rami nerve under ultrasound guidance. |
| Comparator Agent |
Paracetamol 1g |
Postoperatively paracetamol 1g intavenously given |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient between 18-65 yrs both male and female
ASA I and II grade |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the efficacy of erector spinae block as
analgesia in laparoscopic cholecystectomy surgeries |
intraopertively and postoperatively for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To study how effectively erector spinae block reduces opioids, and muscle requirement intraoperatively |
throughout the procedure |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
22/09/2025 |
| 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
|
Erector spinae plane (ESP) block is a regional anaesthesia technique in which local anaesthesia is injected deep into the Erector spinae muscle and transverse process under ultrasound guidance. This block has been shown to provide good postoperative analgesics for thoracic, breast and spine surgeries. ESP block is a paraspinal interfascial plane block targeting the ventral and dorsal branches rami of the spinal nerves |