| CTRI Number |
CTRI/2025/04/084019 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of a pain management technique given at two different levels and at single level for control of pain after open abdominal sugery. |
|
Scientific Title of Study
|
Postoperative analgesic efficacy between bilateral bi level and bilateral single level Erector Spinae Plane Block(ESPB) in patients undergoing emergency/elective laparotomy: A prospective comparison study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivani sharma |
| Designation |
SENIOR RESIDENT, DEPT OF ANAESTHESIOLOGY |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, KATHUA |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, GOVERNMENT MEDICAL COLLEGE KATHUA, JAMMU AND KASHMIR
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
6005571564 |
| Fax |
|
| Email |
shivanisharmaa1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Proffesor , dept of Anaesthesiology |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, KATHUA |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, GOVERNMENT MEDICAL COLLEGE KATHUA, JAMMU AND KASHMIR
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Proffesor , dept of Anaesthesiology |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE, KATHUA |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, GOVERNMENT MEDICAL COLLEGE KATHUA, JAMMU AND KASHMIR
Kathua
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT MEDICAL COLLEGE, KATHUA, JAMMU AND KASHMIR 184101 |
|
|
Primary Sponsor
|
| Name |
Dr Shivani sharma |
| Address |
DEPARTMENT OF ANESTHESIOLOGY AND CRITICAL CARE, GOVERNMENT MEDICAL COLLEGE KATHUA, JAMMU AND KASHMIR |
| Type of Sponsor |
Other [SELF] |
|
|
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 Rajesh Angral |
GOVERNMENT MEDICAL COLLEGE, KATHUA |
DEPARTMENT OF ANAESTHESIOLOGY, GOVERNMENT MEDICAL COLLEGE, KATHUA
Kathua
JAMMU & KASHMIR |
7006047500
rajeshangral73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMC KATHUA |
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 |
| Comparator Agent |
BI LEVEL BILATERAL ESP VS SINGLE LEVEL BILATERAL ESP BLOCK. |
PATIENT WILL BE DIVIDED INTO TWO GROUPS B AND S.
GROUP B WILL RECEIVE 60ml OF TOTAL VOLUME OF DRUG CONTAINING 58ML OF ROPIVACINE(0.25%)AND 2ML OF MAGNESIUM SULFATE (100MG) AT TWO DIFFERENT LEVEL BILATERALLY.
GROUP S WILL RECEIVE THE SAME DRUG VOLUME AND COMPOSITION AT SINGLE LEVEL BILATERALLY. |
| Intervention |
ERECTOR SPINAE PLANE BLOCK |
ESP IS AN INTER FACIAL PLANE BLOCK GIVEN IN PARA SPINAL AREA, IN WHICH THE NEEDLE PLACEMENT IS BETWEEN THE ERECTOR SPINAE MUSCLE AND THORACIC TRANSVERSE PROCESS OF THE VERTEBRAE. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA CLASS 1 and 2
2.Patient who are willing to participate and provide a written consent. |
|
| ExclusionCriteria |
| Details |
1.Patient having any cardiovascular/renal/respiratory abnormalities.
2.Patient allergic to local anesthetic drugs.
3.Patient having peripheral vascular disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.DURATION OF POST-OPERATIVE ANALGESIA USIING VISUAL ANALOG SCALE.
2. TIME TO FIRST RESCUE ANALGESIA
|
VAS score will be recorded at 1, 2, 6, 8, 10, 12 and 24 after the sugery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.SEVERITY OF PAIN USING VISUAL ANALOG SCALE.
2.ANALGESIC CONSUMPTION IN 1ST 24 HOUR.
3. PATIENT SATISFACTION. |
1. SEVERITY OF PAIN USING VISUAL ANALOGUE SCALE AT 0MINS,2MINS, 4MNINS, 6MINS, 8MINS, 12 MINS, 24 HOURS. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| 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 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
|
This prospective comparison study will be conducted to compare the effectiveness of bilateral bi level Erector Spinae Plane Block vs single level bilateral Erector Spinae Plane Block for post-operative analgesia in patients undergoing elective/emergency laparotomy, as measured by duration of analgesia and pain score in 24 hour following surgery. |