| CTRI Number |
CTRI/2025/05/086503 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| 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 two techniques using ultrasound for pain relief in patients undergoing gall bladder surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided erector spinae block versus thoracic paravertebral block in patients undergoing open cholecystectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Seema Jindal |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, GGS medical college and hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9646050485 |
| Fax |
|
| Email |
jindalseema@ggsmch.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Seema Jindal |
| Designation |
Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, GGS medical college and hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9646050485 |
| Fax |
|
| Email |
jindalseema@ggsmch.org |
|
Details of Contact Person
Public Query
|
| Name |
Anmoldeep Singh |
| Designation |
Post graduate student |
| Affiliation |
Guru Gobind Singh Medical College and Hospital |
| Address |
Department of Anaesthesiology, GGS medical college and hospital Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9888816131 |
| Fax |
|
| Email |
anmoldeepsingh61@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of anaesthesia GGS Medical college & hospital Faridkot Punjab 151203 india |
|
|
Primary Sponsor
|
| Name |
Guru Gobind Singh Medical College and Hospital Faridkot |
| Address |
Department of Anaesthesiology GGS Medical college & hospital Faridkot punjab-151203 |
| 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 Seema Jindal |
Guru Gobind Singh Medical college and hospital Faridkot |
Department of Anaesthesiology main operation theater complex second floor GGS Medical college & hospital
Faridkot
PUNJAB |
09646050485
jindalseema@ggsmch.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee GGS Medical college and Hospital Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided erector spinae block |
Patients will receive 20 ml of 0.5% ropivacaine using USG guided erector spinae block at T7 level posted for open cholecystectomy |
| Comparator Agent |
ultrasound guided thoracic paraverterbal block |
patients will receive 20 ml of 0.5% ropivacaine using USG guided htoarcic paravertebral block at T7 level posted for open cholecystectomy |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA grade I and II scheduled for open cholecystectomy under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients with coagulation disorders or local skin infection
2. History of anaphylaxis to local anaesthetics and allergy to study drug
3. Severe cardiovascular, respiartory, liver disease, metabolic and neurological disorder
4. History of psychiatric illness or substance abuse
5.pregnant patients
6. Patient refusal or inability to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| duration of analgesia |
From the time of completion of block till request of first rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.total analgesic consumption 2. pain score using verbal numeric pain rating scale
2. total number of rescue doses given |
1. 24 hours post op
2. 2,4,8,12,18,24 hours postop |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/05/2025 |
| 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
|
The study will be conducted in a comparative manner in GGS Medical college & Hospital Faridkot on 80 patients of either gender belonging to ASA grade I and II scheduled ofr cholecystectomy under G.A.. patients will be randomly allocated into 2 groups of 40 patients each. Group T patients will receive USG guided thoracic paravertebral block at T7 level posted for open cholecystectomy and group E patients will receive USG guided erector spinae block at T7 level posted for open cholecystectomy. The patients will be assessed postoperatively for duration till first rescue analgesic requirement, total anlgesic consumption, pain score using VNRS Pain score at 2,4,8,12,18, 24 hours postoperatively. |