| CTRI Number |
CTRI/2024/07/070975 [Registered on: 22/07/2024] Trial Registered Prospectively |
| Last Modified On: |
18/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To give ESPB in abdominolumbar surgery patients and evaluate for postoperative pain |
|
Scientific Title of Study
|
Erector Spinae Plane Block supplementation to General anaesthesia in abdominolumbar surgeries for postoperative quality of recovery |
| 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 ASHWIN KRISHNAN NAIR |
| Designation |
Postgraduate |
| Affiliation |
Peoples Hospital |
| Address |
Room no 1 first floor Department of anaesthesia
Peoples Hospital Peoples College of Medical Sciences and Research Centre karond bypass road bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9111555711 |
| Fax |
|
| Email |
ashwinkrishnann@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANUPAM PANDEY |
| Designation |
Associate Professor |
| Affiliation |
Peoples Hospital |
| Address |
Room no 2 first floor Department of anaesthesia Peoples Hospital peoples college of medical sciences and research centre karond bypass road bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
8889480540 |
| Fax |
|
| Email |
docanshu07@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHWIN KRISHNAN NAIR |
| Designation |
Postgraduate |
| Affiliation |
Peoples Hospital |
| Address |
Room 1 first floor Department of anaesthesia Peoples Hospital Peoples College of Medical Sciences and Research Centre karond bypass road bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9111555711 |
| Fax |
|
| Email |
ashwinkrishnann@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples Hospital Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037 |
|
|
Primary Sponsor
|
| Name |
Peoples Hospital |
| Address |
Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037 |
| 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 |
| DR ASHWIN KRISHNAN NAIR |
Peoples Hospital |
Room no 1 first floor department of anaesthesia Peoples College of Medical Sciences and Research Centre Karond Bypass Road Bhanpur Bhopal Madhya Pradesh 462037
Bhopal
MADHYA PRADESH |
9111555711
ashwinkrishnann@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Peoples College of Medical Sciences and Research Centre |
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 |
General anesthesia with levo bupivacaine isobaric in erector spinae plane block |
the patients undergoing elective
abdomino lumbar surgeries will be administered with 0.25% levobupivacaine isobaric in erector spinae plane block after induction of general anesthesia and will be assessed for quality of recovery uptill 240 minutes |
| Comparator Agent |
general anesthesia with normal saline in espb |
the patients undergoing elective abdomino lumbar surgeries will be administered with 10ml normal saline as espb after induction of general anesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
ASA grade 3 and 4
not willing to give consent
allergy to levobupivacaine
patient with spinal deformity
psychiatric disorder
chronic neurological disease
pregnant and lactating female
emergency or trauma cases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of recovery |
Patients will be assessed for quality of recovery using QoR15 scale for 240 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| haemodynamic parameters |
240 minutes |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
29/07/2024 |
| 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
|
to compare the effect of erector spinae plane block with levobupivacaine in patients undergoing abdomino lumbar surgeries vs a control group undergoing general anesthesia with erector spinae plane block with normal saline and these patients will be evaluated for post operative quality of recovery till the point of discharge by Qor 15 scale |