| CTRI Number |
CTRI/2025/01/079460 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To Compare Analgesic Efficacy of Serratus Anterior Plane Block and Local Infilteration in Modified Radical Mastectomy Patients |
|
Scientific Title of Study
|
To Evaluate the Analgesic Efficacy of Serratus Anterior Plane Block And Local Infilteration of 0.25 percent Bupivacaine in 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 Swati Singh |
| Designation |
Junior Resident |
| Affiliation |
Gandhi Medical College |
| Address |
Block 1, Second floor
Department of Anaesthesiology
Gandhi Medical College, Bhopal Madhya Pradesh
Block 1 , Second floor
Department of Anaesthesiology
Gandhi Medical College Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7999913190 |
| Fax |
|
| Email |
singhswati994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Awasya |
| Designation |
Professor |
| Affiliation |
Gandhi Medical College |
| Address |
Operation Theatre, Second floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal
Operation Theatre, Second floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
9200314936 |
| Fax |
|
| Email |
awasya.84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Pandey |
| Designation |
Assistant Professor |
| Affiliation |
Gandhi Medical College |
| Address |
Operation Theatre, Second floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal
Operation Theatre, Second floor, Department of Anaesthesiology, Gandhi Medical College, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7898169898 |
| Fax |
|
| Email |
pandeyvandana92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Gandhi medical college Bhopal
462001 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Swati singh |
Gandhi medical college bhopal |
Second floor, Block 1, Gandhi Medical College, Bhopal
Department of Anaesthesiology
Bhopal
MADHYA PRADESH |
7999913190
singhswati994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Local Infilteration with 0.25 percent Bupivacaine |
Local Infilteration with 0.25 percent Bupivacaine is compared with Serratus anterior Plane block in patients undergoing Modified Radical Mastectomy. |
| Intervention |
Nerve block in patients undergoing Modified Radical Mastectomy |
To compare analgesic efficacy of Serratus anterior plane block and local infilteration using 0.25 percent Bupivacaine in patients undergoing modified radical mastectomy. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1) Female patients aged 25-50 yrs old.
2) ASA Class I or II scheduled for elective unilateral MRM
3) Patients giving consent and willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Patients refusal to participate or not giving consent.
2. Local infection at the injection site, morbid obesity,
psychological problem, contraindication to any
researched medicine,
3. Female patients with history of bleeding diathesis, and persistent narcotic abusers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effect of post-operative analgesia of Serratus anterior plane block in modified radical mastectomy patients using VAS score & NRS scale. |
VAS score will be recorded at 0,2,4,8,12,16 and 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe intra operative and post operative opioid requirement and additional analgesia requirements.
To observe duration of anaesthesia in both groups
To observe adverse events if any.
|
At 0,2,4,8,12,16,24 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)
|
04/02/2025 |
| 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="4"
Days="1" |
|
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
|
SAP block is one of the newer thoracic regional anesthetic techniques. This procedure is an alternative to TEB, PVB, intercostal blocks, and intrapleural blocks that are commonly used as postoperative analgesia of the thoracic region. SAP block exerts its analgesic effects on the lateral thoracic region.[8] This effect is achieved by nerve blockade in the axillary fossa which includes the intercostobrachial nerve, the cutaneous intercostal nerve (T3–T9), the thoracic longus nerve, and the thoracodorsal nerve located in the compartment between the serratus anterior muscle and latissimus dorsi muscle and between the posterior and mid-axillary lines.[9] We intend to study the analgesic efficacy of SAP Block using 0.25 % bupivacaine versus conventional method of local infiltertion for Post operative analgeisa in patients undergoing Modified Radical Mastectomy . |