| CTRI Number |
CTRI/2023/05/052566 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study On Comparison Of Pain Relieving Effects Of Local Anaesthetic Injection After Laparoscopic Inguinal Hernia Surgery On The Nerves Around Two Different Muscles |
|
Scientific Title of Study
|
A Comparative Study Of Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block For Postoperative Analgesia In Patients Undergoing Laparoscopic Inguinal Hernia Repair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MANJISTHA SARKAR |
| Designation |
JUNIOR RESIDENT(ACADEMIC) |
| Affiliation |
ESI PGIMSR ESIC MEDICAL COLLEGE & HOSPITAL JOKA |
| Address |
ESI PGIMSR ESIC MEDICAL COLLEGE & HOSPITAL JOKA KOLKATA
DEPARTMENT OF ANAESTHESIOLOGY
3RD FLOOR OT COMPLEX EMERGENCY BUILDING
Kolkata
WEST BENGAL
700104
India |
| Phone |
8906958339 |
| Fax |
|
| Email |
sarkar.manjistha2015@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ATASI DAS |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
ESI PGIMSR ESIC MEDICAL COLLEGE & HOSPITAL JOKA |
| Address |
ESI PGIMSR ESIC MEDICAL COLLEGE & HOSPITAL JOKA KOLKATA
DEPARTMENT OF ANAESTHESIOLOGY
3RD FLOOR OT COMPLEX EMERGENCY BUILDING
Kolkata
WEST BENGAL
700104
India |
| Phone |
9153011075 |
| Fax |
|
| Email |
doc.atasi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANJISTHA SARKAR |
| Designation |
JUNIOR RESIDENT(ACADEMIC) |
| Affiliation |
ESI PGIMSR ESIC MEDICAL COLLEGE & HOSPITAL JOKA |
| Address |
ESI PGIMSR ESIC MEDICAL COLLEGE & HOSPITAL JOKA KOLKATA
DEPARTMENT OF ANAESTHESIOLOGY
3RD FLOOR OT COMPLEX EMERGENCY BUILDING
Kolkata
WEST BENGAL
700104
India |
| Phone |
8906958339 |
| Fax |
|
| Email |
sarkar.manjistha2015@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI-PGIMSR, ESIC MEDICAL COLLEGE & HOSPITAL,BRATACHARI GRAM JOKA KOLKATA PIN 700104 WESTBENGAL INDIA |
|
|
Primary Sponsor
|
| Name |
ESI-PGIMSR,ESIC MEDICAL COLLEGE & HOSPITAL, JOKA |
| Address |
DIAMOND HARBOUR ROAD
BRATACHARI GRAM
JOKA
PIN 700104 |
| 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 |
| MANJISTHA SARKAR |
ESI-PGIMSR, ESIC MEDICAL COLLEGE & HOSPITAL, JOKA |
DEPARTMENT OF ANAESTHESIOLOGY
3RD FLOOR OT COMPLEX
SURGERY OT & PACU
EMERGENCY BUILDING
DIAMOND HARBOUR ROAD
BRATACHARI GRAM
JOKA
PIN 700104
Kolkata
WEST BENGAL |
8906958339
sarkar.manjistha2015@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ESI-PGIMSR & ESIC MEDICAL COLLEGE,JOKA |
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 |
ERECTOR SPINAE PLANE BLOCK |
0.25% BUPIVACAINE 0.3-0.4 ml/kg INJECTED UNDER USG GUIDANCE
BLOCK PERFORMANCE TIME 10 MINUTES
PERIOD OF OBSERVATION 24 HOURS
COMPARATOR AGENT - NOT APPLICABLE |
| Intervention |
QUADRATUS LUMBORUM BLOCK (QL-3) |
0.25% BUPIVACAINE 0.3-0.4 ml/kg INJECTED UNDER USG GUIDANCE
BLOCK PERFORMANCE TIME 10 MINUTES
PERIOD OF OBSERVATION 24 HOURS
COMPARATOR AGENT - NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. PATIENTS UNDERGOING LAPAROSCOPIC INGUINAL HERNIA REPAIR UNDER GENERAL ANAESTHESIA
2. ASA I & II
3. AGE BETWEEN 18 AND 65 YEARS |
|
| ExclusionCriteria |
| Details |
1. PATIENTS REFUSAL
2. PREGNANT PATIENTS AND LACTATING MOTHERS
3. AGE UNDER 18 AND OVER 65 YEARS
4. HISTORY OF ALLERGY TO LOCAL ANAESTHETIC AGENTS USED IN THIS STUDY
5. SKIN LESIONS AT NEEDLE INSERTION SITE
6. BLEEDING DISORDERS, LIVER DISEASE, SEPSIS
7. PSYCHIATRIC DISORDERS |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| THERE WILL BE STATISTICALLY SIGNIFICANT DIFFERENCE IN THE EFFECTIVENESS OF ERECTOR SPINAE PLANE BLOCK IN COMPARISON WITH QUADRATUS LUMBORUM BLOCK |
1 YEAR |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.CUMULATIVE OPIOID CONSUMPTION WILL BE LESSER IN ERECTOR SPINAE PLANE BLOCK
2.BLOCK PERFORMANCE TIME WILL BE LESSER IN ERECTOR SPINAE PLANE BLOCK |
1 YEAR |
|
|
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 3 |
|
Date of First Enrollment (India)
|
01/08/2023 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-05-2023 and end date provided 15-10-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
IN THIS CLINICAL STUDY IT IS HYPOTHESIZED THAT ERECTOR SPINAE PLANE BLOCK IS SUPERIOR FOR POST-OPERATIVE ANALGESIA IN COMPARISON WITH QUADRATUS LUMBORUM BLOCK |