| CTRI Number |
CTRI/2024/08/072354 [Registered on: 12/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between erector spinae plane block and paravertebral block |
|
Scientific Title of Study
|
Comparison of analgesic efficacy between ultrasound guided erector spinae plane block and paravertebral block for postoperative pain in modified radical mastectomy for breast carcinoma. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ravi Kumar Meena |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of anaesthesiology second floor Sir Sunderlal Hospital Institute of Medical Sciences BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09838360334 |
| Fax |
|
| Email |
ravikumarmeena437@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhinay Jayanti |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of Anaesthesiology second floor Sir sunderlal hospital Institute of medical sciences BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09838360334 |
| Fax |
|
| Email |
abhinay2288@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ravi Kumar Meena |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University |
| Address |
Department of anaesthesiology second floor sir sunderlal hospital Institute of medical sciences BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
09838360334 |
| Fax |
|
| Email |
ravikumarmeena437@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh, India, 221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
sir sunderlal hospital Institute of Medical Sciences, Banaras Hindu University, varanasi, uttar pradesh, India, 221005 |
| 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 Ravi Kumar Meena |
sir sunderlal hospital Institute of Medical Sciences |
department of anasethesiology
second floor sir sunderlal hospital Institute of Medical Sciences, Banaras Hindu University
Varanasi
UTTAR PRADESH |
09838360334
ravikumarmeena437@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of Medical Sciences ethics committee BHU |
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, (2) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (3) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae block |
Ultrasound guided ESP block given between erector spinae muscle plane and transverse process of vertebrae with single bolus shot of 30ml of Inj. Ropivacaine 0.375% (112.5 mg) after induction of general anaesthesia once and parameters were monitored at 0 min, 5 min, 10 min, 15 min, 30 min, 60 min, 6 hours, 12 hours and 24 hours |
| Comparator Agent |
Thoracic Para Vertebral Block |
Ultrasound guided Thoracic Paravertebral Block given in the thoracic paravertebral space with single bolus shot of 30ml of Inj. Ropivacaine 0.375% (112.5 mg) after induction of general anaesthesia once and parameters were monitored at 0 min, 5 min, 10 min, 15 min, 30 min, 60 min, 6 hours, 12 hours and 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
56.00 Year(s) |
| Gender |
Female |
| Details |
1. Age 18- 56 years.
2. Patient diagnosed as the case of breast cancer.
3. American society of Anaesthesiologists grade I and II patients
|
|
| ExclusionCriteria |
| Details |
1. Patient with known coagulopathy.
2. Patients allergic to the study drug.
3. Patients with hepatic or renal dysfunction.
4. Patients with history of receiving anticoagulant treatment.
5. Patients having history of chronic opioid consumption.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare post-operative VAS score between ESP block versus thoracic paravertebral block.
|
VAS score will be measured at baseline. Block will be given after induction. VAS score will be measured after induction at 5 mins, 10 mins, 15 mins, 30 mins, 60 mins, 90 mins, 120 mins |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare intraoperative hemodynamic stability between ESP versus thoracic paravertebral block.
2. To observe the time needed for first rescue analgesia.
3. To compare total rescue analgesia dose needed between the two groups.
|
1. hemodynamic parameters will be measured at baseline. Block will be given after induction. further vitals will be measured after induction at 5 mins, 10 mins, 15 mins, 30 mins, 60 mins, 90 mins, 120 mins |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Prospective, randomized
single blinded study. After obtaining the
institutional ethical committee approval and written informed consent from the
participants, they will be enrolled into our study.
A total of 60 participants
will be enrolled and randomized into two equal groups of 30 each.
Group ESP: Ultrasound
guided ESP block with 30ml of Inj. Ropivacaine 0.375%
Group PVB: Ultrasound
guided Thoracic PVB with 30ml of Inj. Ropivacaine 0.375% ·
Hemodynamic parameters will be monitored at different time
point such as baseline, after induction, after block
and after every 15 minute interval.
ü Systolic blood pressure
ü Diastolic blood pressure
ü Heart rate
ü Mean arterial pressure
·
Duration of surgery.
·
Total intraoperative inj. fentanyl consumption.
·
VAS score will be monitored at 0min, 15 minutes, 30 minutes 1
hour, 2 hours, 6hour, 12 hour, 24 hours post-operatively.
·
Time for requirement of first rescue analgesia will be noted.
·
Total rescue analgesia in 24 hours will be noted.
|