| CTRI Number |
CTRI/2020/07/026929 [Registered on: 31/07/2020] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the efficiency of ultrasound guided nerve block for pain control after breast surgery |
|
Scientific Title of Study
|
To study the efficacy of ultrasound guided Erector spinal plane block for post operative analgesia after modified radical mastectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| None |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Puneet Goyal |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi postgraduate institute of medical sciences |
| Address |
A block, department of anaesthesia, old OPD, Sanjay Gandhi postgraduate institute, raebarailley road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904597 |
| Fax |
|
| Email |
princeofcoma@yahoo.co.uk |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Goyal |
| Designation |
Professor |
| Affiliation |
Sanjay Gandhi postgraduate institute of medical sciences |
| Address |
A block, department of anaesthesia, old OPD, Sanjay Gandhi postgraduate institute, raebarailley road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904597 |
| Fax |
|
| Email |
princeofcoma@yahoo.co.uk |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Ranjan |
| Designation |
Junior Resident |
| Affiliation |
Sanjay Gandhi postgraduate institute of medical sciences |
| Address |
A block, department of anaesthesia, old OPD, Sanjay Gandhi postgraduate institute, raebarailley road, Lucknow
A block, department of anaesthesia,old pod, Sanjay Gandhi postgraduate institute, raebarailley road, Lucknow
Lucknow
UTTAR PRADESH
226014
India |
| Phone |
8004904621 |
| Fax |
|
| Email |
dr.shalinirims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi postgraduate institute |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi postgraduate institute |
| Address |
Raebarailley road, Lucknow |
| 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 |
| Puneet Goyal |
Endocrine surgery operation theatre |
OT complex, Sanjay Gandhi postgraduate institute, raebarailley road, Lucknow
Lucknow
UTTAR PRADESH |
8004904597
princeofcoma@yahoo.co.uk |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGPGI ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E898||Other postprocedural endocrine andmetabolic complications and disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Usg guided erector spinae block |
Under aseptic precaution usg guided erector spinae block by local anaesthetic 0.25% of 20 ml bupivacaine is given at plane and catheter is secured with top ups of 0.25% of 20 ml bupivacaine is given 8 hourly till 48 hours and then catheter is removed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patient undergoing modified radical mastectomy without lattisimus dorsi flap |
|
| ExclusionCriteria |
| Details |
Patient of ASA grade lll & IV, non cooperative,frozen shoulder, requiring post operative mechanical ventilator |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of USG guided Erector Spinae plane block (USG-ESPB) in reducing pain (static and dynamic) after MRM. |
To study the efficacy of USG guided Erector Spinae plane block (USG-ESPB) in reducing pain (static and dynamic) after MRM. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To study the side effects associated with usg guided esp block 2.duration of analgesia after use guided esp block. 3.total amount of rescue analgesia required |
1.5 yrs |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2020 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To study the efficacy of ultrasound guided erector spinal plane block for post operative analgesia after modified radical mastectomy to see the reduction of pain both static and dynamic till 48 hours |