| CTRI Number |
CTRI/2024/06/068661 [Registered on: 11/06/2024] Trial Registered Prospectively |
| Last Modified On: |
10/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the usefulness between two different chest blocks for pain relief in patients posted for chest surgery |
|
Scientific Title of Study
|
Comparing erector spinae plane block and serratus anterior plane block for quality of recovery in patients posted for thoracotomy A prospective randomised double blinded controlled 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 Chandra Shekhar kumar |
| Designation |
Post graduate student |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia neuro OT complex. 1st floor ward block,IGIMS,Sheikhpura, Patna,Bihar 800014 India
Patna
BIHAR
800014
India |
| Phone |
6201575759 |
| Fax |
|
| Email |
chandrashekhar613@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandra Shekhar kumar |
| Designation |
Post graduate student |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia,Neuro OT complex,1ST floor ward block,IGIMS,Sheikhpura, Patna,Bihar 800014 India
Patna
BIHAR
800014
India |
| Phone |
6201575759 |
| Fax |
|
| Email |
chandrashekhar613@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ALOK KUMAR BHARTI |
| Designation |
Associate professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anaesthesia,Neuro OT complex,1ST floor ward block,IGIMS,Sheikhpura, Patna,Bihar 800014 India
Patna
BIHAR
800014
India |
| Phone |
6392180381 |
| Fax |
|
| Email |
alok.bharti48@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences,Patna,Bihar,India, 800014 |
|
|
Primary Sponsor
|
| Name |
Dr Chandra Shekhar Kumar |
| Address |
Department of Anaesthesia,Neuro OT complex,1ST floor ward block,IGIMS,Sheikhpura, Patna,Bihar 800014 India |
| 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 Chandra shekhar kumar |
Indira gandhi institute of medical sciences,patna |
Department of Anaesthesia,Neuro OT complex,1ST floor ward block,IGIMS,Sheikhpura, Patna,Bihar 800014 India
Patna
BIHAR |
6201575759
chandrashekhar613@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INDIRA GANDHI INSTITUTE OF MEDICAL SCIENCES,PATNA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
Group ESP will receive 0.375% ropivacaine(0.5 ml/kg) with general anaesthesia to assess the quality of recovery(QOR) at 24 hours. |
| Comparator Agent |
Serratus anterior plane block |
Group SAP will receive 0.375% ropivacaine(0.5ml/kg) with general anaesthesia to assess quality of recovery(QOR) at 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients age between 18-70 years of either sex
Patients able to comprehend and willing to participate
ASA physical status l-lll
Patients scheduled to undergo for unilateral thoracotomy under general anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients refusal to participate
Allergy to local anaesthetics
Chronic opioid use or history of chronic pain
Infection at block site
Cognitive dysfunction or psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is to assess quality of recovery using QOR-15 scale at 24 hours postoperatively. |
Postoperative 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess pain score using NRS scale upto 24 hours,time to rescue analgesia use,total analgesic consumption upto 24 hours,patients satisfaction and any adverse effects seen. |
Pain score will be recorded at rest and during coughing using NRS scores at 0,3,6,12,18 and 24 hours. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
01/07/2024 |
| 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
|
A total of 120 thoracotomy patients have been equally divided into 2 groups(60 in each groups) receiving ESP and SAP blocks.Both group will receive 0.375% ropivacaine(0.5 ml/kg) with general anaesthesia.Patients included in our study are of age group between 18-70 years,ASA physical status 1-3,those willing to participate and able to comprehend.Patients excluded in our study are those allergic to local anaesthesia,chronic opioid use,infection at block site,cognitive dysfunction or psychiatric illness.We will compare ESP and SAP blocks and primary outcome will be to assess quality of recovery using QOR-15 scale at 24 hr postoperatively.and secondary outcome will be to assess post operative analgesia using NRS scale at 0,3,6,12,18 and 24 hours. |