| CTRI Number |
CTRI/2020/02/023252 [Registered on: 11/02/2020] Trial Registered Prospectively |
| Last Modified On: |
18/04/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ultrasound guided thoracic block by two different approach in breast surgeries |
|
Scientific Title of Study
|
"Comparison of ultrasound guided thoracic paravertebral block versus ultrasound guided thoracic erector spinae plane block for postoperative analgesia in Modified Radical Mastectomy: A Prospective Randomized Study" |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jyoti mala |
| Designation |
Senior resident |
| Affiliation |
IGIMS |
| Address |
Department of Anaesthesiology and Critical care, First floor
IGIMS, Sheikhpura,Patna
C/O - Dr.R.P. Sinha, Flat no- 103/B2 Block, IIT Campus,IIT, Bihta, Patna PIN 801103
Patna
BIHAR
800014
India |
| Phone |
9955882635 |
| Fax |
|
| Email |
drmalajyoti17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swati |
| Designation |
Associate professor |
| Affiliation |
IGIMS |
| Address |
Department of Anaesthesiology and Critical care, First floor
IGIMS, sheikhpura, patna
Department of Anaesthesiology and Critical care, First floor
IGIMS, sheikhpura, patna
Patna
BIHAR
800014
India |
| Phone |
854441341 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati |
| Designation |
Associate professor |
| Affiliation |
IGIMS |
| Address |
Department of Anaesthesiology and Critical care, First floor
IGIMS, sheikhpura, patna
Department of Anaesthesiology and Critical care, First floor
IGIMS, sheikhpura, patna
Patna
BIHAR
800014
India |
| Phone |
854441341 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Jyoti mala
Department of Anaesthesiology and Critical care, First floor
IGIMS, Sheikhpura,Patna
PIN - 800014 |
|
|
Primary Sponsor
|
| Name |
Jyoti mala |
| Address |
C/O - Dr. Jyoti mala
Senior Resident
Department of Anaesthesiology and Critical care, First floor
IGIMS, Sheikhpura, Patna-14
|
| 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 Swati |
Indira Gandhi Institute Of Medical Sciences. |
Department of Oncology & Surgery, Ward, Bed no 1-60
Patna
BIHAR |
8544413241
deepakswat@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Indira gandhi institute of medical sciences ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
thoracic erector spinae plane block |
Thoracic Erector Spinae Plane (TESP) Block For this, the needle tip will be directed under ultrasound guidance towards the T5 transverse process until the needle tip contacts os. Then, a few milliliters of 0.25%Bupivacaine will be injected slowly to separate the plane between the erector spinae muscle and the transverse process. After negative aspiration, the rest of the 0.25% Bupivacaine will be injected (total 20ml) |
| Intervention |
thoracic paravertebral block |
Paravertebral Block (TPVB) by usingan ultrasound to guide the needle tip to a point between the costotransverse ligament and the parietal pleura between the visualized transverse processes at T5 level. Then, a few milliliters of 0.25% bupivacaine will be injected slowly to displace the pleura ventrally as the paravertebral space fills with local anesthetic. After negative aspiration, the rest of 0.25% bupivacaine (total 20 ml) will be injected in 5 ml increments to further fill the paravertebral space. We will observe local anesthetic spread under real-time ultrasound imaging. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for unilateral MRM operation
Patients able to comprehend, willing to participate &Willing to give written informed consent in English or Hindi
Patients of ASA physical status 1, 2& 3
Patients between 20 - 60 years of age of either sex
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal to participate
Patients of ASA physical status 4
Any allergy to local anaesthetics
Coagulation disorders
Infection at the site of intervention
History of any underlying cardiac, renal or hepatic dysfunction
Pregnant patient
Age less than 20 or greater than 60 years
Chronic opioid use or drug abuse
Significant psychiatric disturbance
Refusal to provide written consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Pain score at the interval of 2, 4, 6 12, & 24 hour
Pain score via Numeric Rating Scale (0-10)
2.Total opioid consumption for 24 h in postoperative period
|
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic changes
2.Patient satisfaction score
3.any adverse effect in either group
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/02/2020 |
| Date of Study Completion (India) |
07/04/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Modified Radical Mastectomy is a common surgical procedure .post mastectomy pain managed by opioids alone often leads to side effects such as nausea and vomiting, drowsiness, pruritis and respiratory depression, etc. Inadequate pain control leads to chronic pain syndrome. For this reason regional anaesthetic technique have been advocated for effective pain relief.USG guided thoracic paravertebral block(TPBV) has been proven to provide perioperative analgesia in breast surgeries.A relatively recent tecnique thoracic erector spinae plane block(TESP).It is increasingly being used due to ease of placing the block and of greater safety,more superficial so less chance of haemothorax.However, till date TPVB has not been compared with TESP block in regaeds to analgesia in MRM.So our study is design to campare USG guided TPVB and TESP for postoperative analgesia in MRM. |