| CTRI Number |
CTRI/2023/01/049272 [Registered on: 30/01/2023] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to study and compare two regional blocks for breast cancer surgery |
|
Scientific Title of Study
|
to study and compare the efficiency of erector spinae block vs pectoralis nerve block for post operative analgesia in breast cancer surgery:a prospective randomised control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M SNEHA PRIYA |
| Designation |
RESIDENT Anaesthesia |
| Affiliation |
command hospital central command , lucknow |
| Address |
DEPT OF ANESTHESIA AND CRITICAL CARE, COMMAND HOSPITAL LUCKNOW
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9682333913 |
| Fax |
|
| Email |
maripatisneha91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanil Mohan |
| Designation |
professor |
| Affiliation |
command hospital central command , lucknow |
| Address |
DEPARTMENT OF ANESTHESIA AND CRITICAL CARE, COMMAND HOSPITAL, LUCKNOW
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9876468707 |
| Fax |
|
| Email |
sanab1991@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
M SNEHA PRIYA |
| Designation |
RESIDENT Anaesthesia |
| Affiliation |
command hospital central command , lucknow |
| Address |
DEPARTMENT OF ANESTHESIA AND CRITICAL CARE, COMMAND HOSPITAL LUCKNOW
Lucknow
UTTAR PRADESH
226002
India |
| Phone |
9682333913 |
| Fax |
|
| Email |
maripatisneha91@gmail.com |
|
|
Source of Monetary or Material Support
|
| command hospital central command lucknow |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesia and critical care |
| Address |
command hospital central command
lucknow |
| Type of Sponsor |
Other [command hospital central command , lucknow] |
|
|
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 |
| sneha priya |
command hospital |
command hospital, central command, lucknow
Lucknow
UTTAR PRADESH |
9682333913
maripatisneha91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,CH(CC) |
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
PECS Block VS ESP Block |
pain relief will be compared between two groups in first 24 hrs post block |
| Intervention |
pectoralis nerve block and erector spinae block |
one group will receive ESP block using 30 ml of 0.25% Bupivacaine and other group will receive PECS (I and II) block using 30 ml 0.25% Bupivacaine under ultrasound guidance ,time of intervention would be 15-20 minutes prior induction of GA. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
all patient will undergo breast cancer surgery
ASA I or ASA II
|
|
| ExclusionCriteria |
| Details |
Local infection at the block site
coagulopathy
autoimmune disease
morbid obesity
chest wall deformity
psychiatric illness
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| time duration and intensity of pain post block using NRS and VAS score |
first 24 hours post op |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare any complication associated with the blocks in the two groups |
1 year |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2023 |
| Date of Study Completion (India) |
31/05/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
to study and compare the efficacy of erector spinae block vs PECS block for post operative analgesia in breast cancer surgery: A prospective randomised controlled single blinded trial.pain relief will evaluated by using NRS pain scale and total cumulative rescue analgesia in first 24 hrs.
|