| CTRI Number |
CTRI/2024/10/074857 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
06/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparison study of the superficial and deep serratus anterior plane block in providing post operative analgesia |
|
Scientific Title of Study
|
A study comparing the two USG guided approaches (superficial and deep) of serratus anterior plane block in providing post operative analgesia for patients undergoing unilateral modified radical mastectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abirami M |
| Designation |
MD Anesthesia |
| Affiliation |
Sree Balaji medical college and hospitals |
| Address |
Sree Balaji medical college and hospitals
No. 7, clc works road, chrompet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9585531520 |
| Fax |
|
| Email |
m.abirami016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V. S. Senthilkumar |
| Designation |
Associate Professor |
| Affiliation |
Sree Balaji medical college and hospitals |
| Address |
Sree Balaji medical college and hospitals
No. 7, clc works road, chrompet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9585531520 |
| Fax |
|
| Email |
dr.vs.md@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abirami M |
| Designation |
MD Anesthesia |
| Affiliation |
Sree Balaji medical college and hospitals |
| Address |
Sree Balaji medical college and hospitals
No. 7, clc works road, chrompet
Chennai
Chennai
TAMIL NADU
600044
India |
| Phone |
9585531520 |
| Fax |
|
| Email |
m.abirami016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sree Balaji medical college and hospitals - Chennai |
|
|
Primary Sponsor
|
| Name |
Dr V S Senthilkumar |
| Address |
Sree Balaji medical college and hospitals
No. 7, clc works road, chrompet
Chennai-600044
India
|
| 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 Abirami M |
Sree Balaji medical college and hospitals |
Department of anesthesia, Sree Balaji medical college and hospitals, Chennai
Chennai
TAMIL NADU |
9585531520
m.abirami016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sree Balaji medical college and hospitals Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Deep serratus anterior plane block |
20 mL of 0.375% ropivacaine with 4 mg inj dexamethasone |
| Comparator Agent |
Superficial serratus anterior plane block |
20 mL of 0.375% ropivacaine with 4mg inj dexamethasone |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 to 65 years
Both genders
ASA 1,2,3 |
|
| ExclusionCriteria |
| Details |
Patient refusal
Coagulation defects
Patients with psychiatric disorders
BMI less than 18 and more than 35
Allergic study drug
Surgery duration more than 3 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesic requirement in the post operative period |
0, 1 , 2, 4, 6, 12, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesics and its duration from the time the block is performed |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
28/10/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the efficacy of the two ultrasound guided approaches superficial and deep to the serratus anterior plane block in the post operative analgesia in patients undergoing modified radical mastectomy, with 20 mL of 0.375% ropivacaine with 4 mg inj dexamethasone. The pain score is analysed in immediate post operative period, 1 st , 2nd, 4 th, 6th, 12 th, 24 th hour and the post operative analgesia and its duration from the time of block performed and its subsequent requirement of analgesia are analysed. And the final output of the efficacy of the two blocks and compared. |