| CTRI Number |
CTRI/2019/06/019656 [Registered on: 13/06/2019] Trial Registered Prospectively |
| Last Modified On: |
23/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of post operative pain relief by comparing the effect of two nerve blocks given to patients undergoing breast removal surgery. |
|
Scientific Title of Study
|
Comparing the efficacy and safety of ultrasound guided Modified PECS block vs. Erector Spinae block for postoperative pain management in patients undergoing Modified Radical Mastectomy. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ANSU/ANESTH/DNB/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Annet Susan Abraham |
| Designation |
DNB Junior Resident ANAESTHESIOLOGY |
| Affiliation |
MAX SUPER SPECIALITY HOSPITAL, SAKET |
| Address |
OPERATION THEATRE, FIRST FLOOR, WEST BLOCK, MAX SUPER SPECIALITY HOSPITAL SAKET, PRESS ENCLAVE ROAD, SAKET, NEW DELHI
South
DELHI
110017
India |
| Phone |
7907576437 |
| Fax |
|
| Email |
annetabraham92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Punit Mehta |
| Designation |
Principal Consultant ANAESTHESIOLOGY |
| Affiliation |
MAX SUPER SPECIALITY HOSPITAL, SAKET |
| Address |
OPERATION THEATRE, FIRST FLOOR, WEST BLOCK, MAX SUPER SPECIALITY HOSPITAL SAKET, PRESS ENCLAVE ROAD, SAKET, NEW DELHI
South
DELHI
110017
India |
| Phone |
7907576437 |
| Fax |
|
| Email |
drpunitmehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annet Susan Abraham |
| Designation |
DNB Junior Resident ANAESTHESIOLOGY |
| Affiliation |
MAX SUPER SPECIALITY HOSPITAL, SAKET |
| Address |
Operation Theatre, First Floor, West Block, Max Super Speciality Hospital, Saket, Press Enclave Road, Saket 110017 New Delhi
South
DELHI
110017
India |
| Phone |
7907576437 |
| Fax |
|
| Email |
annetabraham92@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAX SUPER SPECIALITY HOSPITAL, SAKET, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 Annet Susan Abraham |
Max Super Speciality Hospital Saket |
Department of General Anaesthesia, Operation Theatre, First Floor, West Block
South
DELHI |
7907576437
annetabraham92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAX HEALTHCARE ETHICS 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 |
Erector Spinae Block |
USG guided nerve block |
| Intervention |
Modified PECS Block |
USG guided nerve block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
Weight > 50 kgs |
|
| ExclusionCriteria |
| Details |
Pregnancy, any bleeding disorders, infection at injection site, severe/morbid obesity,allergy to local anaesthetics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing efficacy of modified PECS block vs. Erector Spinae block in postop period using NRS score and fentanyl requirement in the first 24 hours. |
First 24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Requirement of intraop fentanyl, incidence of PONV, Ease of physiotherapy in postop period, Patient satisfaction using 7 point Likert questionnaire, any other complications |
First 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/06/2019 |
| 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="1"
Months="0"
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
|
This will be a prospective randomised study comparing the efficacy and safety of USG guided modified PECS block vs. Erector Spinae block for postoperative pain management in patients undergoing modified radical mastectomy. The main objective of this study is to compare the analgesic efficacy and safety of these blocks. |