| CTRI Number |
CTRI/2023/05/052970 [Registered on: 22/05/2023] Trial Registered Prospectively |
| Last Modified On: |
19/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two different types of technique of anaesthesia for
pain relief in patients undergoing breast surgeries. |
|
Scientific Title of Study
|
Pectoral Nerve Block versus Erector Spinae block for Modified Radical Mastectomy: A 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 |
Nalini Singh |
| Designation |
III Year Resident Doctor |
| Affiliation |
Sardar Patel medical college |
| Address |
Department of Anaesthesia, Sardar Patel medical college, Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
8554097425 |
| Fax |
|
| Email |
nalinisingh1117@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonali Dhawan |
| Designation |
Head of Department of Anaesthesia |
| Affiliation |
Sardar Patel medical college |
| Address |
Department of Anaesthesia, Sardar Patel medical college, Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sonali Dhawan |
| Designation |
Head of Department of Anaesthesia |
| Affiliation |
Sardar Patel medical college |
| Address |
Department of Anaesthesia, Sardar Patel medical college, Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
9414137866 |
| Fax |
|
| Email |
sonaligsoni@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sardar Patel medical college,Bikaner ,Rajasthan |
|
|
Primary Sponsor
|
| Name |
Sardar Patel Medical College ,Bikaner ,Rajasthan |
| Address |
Department of Anaesthesiology, Sardar Patel Medical College, Bikaner, Rajasthan |
| 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 |
| DrSonali Dhawan |
Sardar Patel Medical College |
Department of Anaesthesiology, PBM Hospital
Bikaner
RAJASTHAN |
9414137866
sonaligsoni@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutions Ethical and Research Board , Sardar Patel medical college, bikaner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5 % Ropivacaine 30 ml with 1u/kg Dexmedetomidine |
This local anaesthetic drug along with adjuvant will be given in both the groups . |
| Intervention |
PEC Block and ESP block |
Pectoral nerve block and erector spinae block will be given 30 mins before surgery in patients undergoing elective Modified Radical Mastectomy divided into two groups of group P and E respectively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
I.Female patients with no ethnicity or nationality restrictions
II.ASA PS- I-III |
|
| ExclusionCriteria |
| Details |
I.Patient refusal
II. Known allergy to the drug used in the study
III. ASA PS > III
IV. Local site infection |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The efficacy of Pectoral nerve block versus Erector Spinae block in Elective MRM patients using 0.5% Ropivacaine with dexmedetomidine as adjuvant in terms of quality, duration of perioperative analgesia |
At baseline,15mins,30mins,1hr,2hrs,4hrs,6hrs,12hrs,24hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perioperative hemodynamic stability along with side effects , complications and Patients’ satisfaction |
Till complete effect of drug is over |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In order to achieve perioperative analgesia , two methods of regional anaesthestic technique (Pectoral nerve block versus Erector spinae block ) along with general anaesthesia will be performed in patients undergoing elective MRM . The principle objective being comparison of two techniques in terms of quality and duration of analgesia and also to provide opioid free analgesia . |