| CTRI Number |
CTRI/2025/01/079376 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison for postoperative pain relief between two groups one receiving usg guided Thoracic Paravertebral Block and other receiving Usg guided Erector Spinae Plane Block in Breast surgery that is MRM in breast cancer patients |
|
Scientific Title of Study
|
A Comparative Study of ultrasound guided Thoracic Paravertebral Block versus ultrasound guided Erector Spinae Plane Block for post operative analgesia in Modified Radical Mastectomy |
| 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 Mukesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Dept of Anesthesia, GGS Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9464887097 |
| Fax |
|
| Email |
mukeshktala@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Dept of Anesthesia, GGS Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9464887097 |
| Fax |
|
| Email |
mukeshktala@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar |
| Designation |
Associate Professor |
| Affiliation |
Guru Gobind Singh Medical College and Hospital, Faridkot |
| Address |
Dept of Anesthesia, GGS Medical College and Hospital, Faridkot
Faridkot
PUNJAB
151203
India |
| Phone |
9464887097 |
| Fax |
|
| Email |
mukeshktala@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology GGSMCH, Faridkot, Punjab, India, 151203 |
|
|
Primary Sponsor
|
| Name |
Dr Mukesh Kumar |
| Address |
Department of Anesthesiology ,
Guru Gobind Singh medical college and hospital ,Faridkot, punjab(151203) |
| Type of Sponsor |
Other [Government medical college and hospital] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sarvjeet Kaur |
Department of Anesthesiology GGSMCH Faridkot |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Alisha Arora |
Guru Gobind Singh Medical College and Hospital, Faridkot |
Department of Anesthesiology GGSMCH Faridkot Punjab
Faridkot
PUNJAB |
9464911462
anayaalisha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Block |
Patients will receive 20ml of 0.25% Levobupivacaine through USG
guided erector spinae plane block at T5 level,then analgesic duration will be assessed in postoperative period. |
| Comparator Agent |
Paravertebral Block |
Patients will receive 20ml of 0.25% Levobupivacaine through USG
guided thoracic paravertebral block at T5 level,then analgesic duration will be assessed in postoperative period |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients belonging to ASA grade I & II
2. Females aged 18 – 65 years
3. Patient posted for elective unilateral modified radical mastectomy |
|
| ExclusionCriteria |
| Details |
1. Patients undergoing bilateral MRM.
2. Local infection at the site of block
3. Patients with renal (or) hepatic insufficiency.
4. Known allergy to study drugs
5. Patient with bleeding diathesis
6. Pregnant patients
7. Patients with history of underlying psychological disorder
8. Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total post operative fentanyl consumption in first 24 hours, pain assessment using VAS at 2, 4, 6, 8, 10, 12, 16, 20 & 24 hours post operatively, time for first dose rescue analgesia. |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome measures include intra operative hemodynamic variables and
side effects of respective block |
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="1"
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
|
The aim of the study is to compare the postoperative analgesic efficacy of levobupivacaine in ultrasound guided thoracic paravertebral block vs levobupivacaine in ultrasound guided erector spinae plane block in patients undergoing modified radical mastectomy. The study will be conducted in a comparative manner in GGS Medical College and Hospital, Faridkot on 80 adult females belonging to American Society of Anesthesiologists (ASA) Grade I and II scheduled for modified radical mastectomy under general anaesthesia. Patients will be randomly allocated into two groups of 40 each. Group P: Patients will receive 20ml of 0.25% Levobupivacaine through USG guided thoracic paravertebral block at T5 level. Group E: Patients will receive 20ml of 0.25% Levobupivacaine through USG guided erector spinae plane block at T5 level. The patients will be observed postoperatively for duration till first rescue analgesic requirement, total rescue analgesic consumption, pain score using visual analogue score and any side effects in the form of pneumothorax, hypotension, bradycardia, epidural or intrathecal spread, vascular puncture, nerve damage, horner’s syndrome, infection at injection site, post operative nausea & vomiting, headache or sedation. |