| CTRI Number |
CTRI/2022/09/045388 [Registered on: 09/09/2022] Trial Registered Prospectively |
| Last Modified On: |
03/09/2022 |
| 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
|
Ultrasound guided serratus anterior plane block for pain relief after Mastectomy (breast surgeries) |
|
Scientific Title of Study
|
A Prospective randomized single blinded study to compare the effect of serratus anterior plane block on postoperative analgesia after Mastectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V Niraimozhi |
| Designation |
Junior Resident |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Anaesthesiology and Pain medicine
Sri Ramachandra Institute Of Higher Education and Research
1,Mount poonamalle road,Ramachandra nagar,Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
7639151595 |
| Fax |
|
| Email |
m2320019@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SENTHILKUMAR |
| Designation |
Associate professor |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of anaesthesiology and pain medicine
Sri Ramachandra Institute of Higher Education and Research
1 Mount poonamalle road Ramachandra nagar Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
7639151595 |
| Fax |
|
| Email |
drsenthilkumar17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Niraimozhi |
| Designation |
Junior Resident |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research
1 Mount poonamalle road Ramachandra nagar Porur
Chennai
TAMIL NADU
600116
India |
| Phone |
7639151595 |
| Fax |
|
| Email |
m2320019@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Niraimozhi V |
| Address |
Department of Anaesthesiology and Pain Medicine
Sri Ramachandra Institute of Higher Education and Research
1 Mount poonamalle road Ramachandra nagar Porur |
| Type of Sponsor |
Other [Self] |
|
|
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 V Niraimozhi |
Sri Ramachandra Institute of Higher Education and Research |
Department of Anaesthesiology and Pain Medicine
1 Mount poonamalle road Ramachandra nagar Porur
Chennai
TAMIL NADU |
7639151595
m2320019@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Control group-no block will be given |
No nerve block will be given to this group.Following transfer to PACU Inj.Morphine will be given to the patient at an IV bolus dose of 0.1mg/ml to 0.2mg/kg 15minutes postoperatively in PACU.The pump settings are Inj.Morphine 1mg/ml,bolus dose 1mg with a lockout interval 20minutes and a maximum dose 2mg per hour.During postoperative period each patients pain level will be assessed by the Visual Analog Scale score for pain. |
| Intervention |
Serratus Anterior Plane block group |
Post Intubation patient will receive ultrasound guided Serratus Anterior Plane block with 15ml of 0.25% Bupivacaine.Following transfer to PACU Inj. Morphine will be given to the patient at an IV bolus dose of 0.1mg/ml to 0.2mg/ml per kg 15minutes postoperatively in PACU.The pump settings are Inj. Morphine 1mg/ml,bolus dose 1mg with a lockout interval 20minutes and a maximum dose 2mg per hour.During postoperative period each patients pain level will be assessed by the Visual Analog Scale score for pain. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
ASA status I to III patients posted for Mastectomy |
|
| ExclusionCriteria |
| Details |
1.Refusal to participate in the study
2.Age less than 18 years.
3.ASA class IV and V
4.Known coagulation disorders.
5.Allergy to Local anaesthetics.
6.Unconscious or mentally incompetent prior to surgery
7.Pregnancy
8.Hemodynamic instability (SBP less than 90mmHG,MAP less than 60mmHG) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare cumulative opioid consumption in both groups |
24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess analgesic efficacy using Visual Analog Scale |
Visual Analog Scale score at 15mins,1hr,2hr,4hs,8hr,12hr,16hr,20hr and 24hr intervals shall be monitored |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
15/09/2022 |
| 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="0"
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
|
The use of ultrasound in regional anaesthesia has facilitated the visualisation of anatomical structures,needle advancement and the spread of local anaesthetic.This has led to the further refinement of fascial plane blocks,in which the local anaesthetic is injected into a tissue plane rather than around individual nerves.Introduces by Blanco et al,Serratus Anterior Plane block is a novel form of ultrasound guided regional anaesthesia fascial plane block that can achieve paraesthesia of the hemithorax.This study evaluates the analgesic efficacy of Serratus Anterior Plane block on acute pain after Mastectomy.The study participants are divided into two groups. Group-A is control group where no block will be given, Group-B is Serratus Anterior Plane block group, these participants after intubation they will be getting block under ultrasound guidance.At the end of the surgery, post extubation following transfer to PACU,both groups will be getting Intravenous Inj.Morphine using Patient Controlled Analgesia pump. The primary outcome of this study is to compare cumulative opioid consumption in both groups. The secondary outcome is to assess the analgesic efficacy using Visual Analog Scale. |