| CTRI Number |
CTRI/2024/09/073625 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ultrasound guided superficial versus deep SAP block in providing postoperative analgesia after mastectomy A prospective randomized double blinded trial |
|
Scientific Title of Study
|
Comparison of ultrasound guided superficial versus deep Serratus anterior plane block in providing postoperative analgesia after mastectomy A prospective randomized double blinded trial |
| 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 KAMAAL MOHIDEEN KHAN B |
| Designation |
Junior Resident |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department Of Anaesthesiology,Sri Ramachandra Institute Of Higher Education And Research
Chennai
TAMIL NADU
600116
India |
| Phone |
9445925630 |
| Fax |
|
| Email |
drkamaalmohideen@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUNA PARAMESWARI |
| Designation |
Head Of Department |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
Department Of Anaesthesiology,Sri Ramachandra Institute Of Higher Education And Research
Chennai
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
hod.anaesthesiology@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DR ARUNA PARAMESWARI |
| Designation |
Head Of Department |
| Affiliation |
Sri Ramachandra Institute Of Higher Education And Research |
| Address |
HOD,Department Of Anaesthesiology,Sri Ramachandra Institute Of Higher Education And Research
Chennai
TAMIL NADU
600116
India |
| Phone |
9840529863 |
| Fax |
|
| Email |
hod.anaesthesiology@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute Of Higher Education And Research ,Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
| Address |
Sri Ramachandra Institute Of Higher Education And Research,Porur, Chennai-600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 KAMAAL MOHIDEEN KHANB |
Sri Ramachandra Institute Of Higher Education And Research |
OR Complex,Department Of Anaesthesiology,Sri Ramachandra Institute Of Higher Education And Research
Chennai
TAMIL NADU |
9445925630
drkamaalmohideen@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL RESEARCH ETHICS 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 |
DEEP SERRATUS ANTERIOR PLANE BLOCK |
The serratus anterior plane block (SAP block) is a safe and simple block
that is performed under ultrasound guidance by administering local anesthetic in the plane between the serratus
anterior muscle and the ribs at the mid-axillary line between the 4th and 5th ribs(deep SAP block). Duration of Intervention:10 Minutes |
| Intervention |
SUPERFICIAL SERRATUS ANTERIOR PLANE BLOCK |
The serratus anterior plane block (SAP block) is a safe and simple block
that is performed under ultrasound guidance by administering local anesthetic in the plane between
the serratus anterior and latissimus dorsi muscles (superficial SAP block). Duration of Intervention:10 Minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. American society of Anaesthesiologists (ASA) status I-III
2. Female patients posted for unilateral mastectomy |
|
| ExclusionCriteria |
| Details |
1. BMI > 50
2. Allergy to LA
3. Coagulopathy
4. Local infection at block site
5. Preoperative opioid use
6. Inability to provide informed consent
7. Patient refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cumulative 24 hour IV PCA morphine consumption in both the groups |
24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS scores with rest and movement
Time to first rescue analgesic
Postoperative Sedation scores |
0,1,4,8, 12, 24 hours |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
19/09/2024 |
| 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
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Breast surgery is becoming more common in women. Surgical incisions in the breast and axillary areas cause severe discomfort, with a high frequency of acute pain escalating to chronic pain in 25% to 60% of patients. The serratus anterior plane block (SAP block) is a safe and simple block that is performed under ultrasound guidance by administering local anesthetic in the plane between the serratus anterior and latissimus dorsi muscles (superficial SAP block) or between the serratus anterior muscle and the ribs at the mid-axillary line between the 4th and 5th ribs(deep SAP block). Dexmedetomidine can extend the duration of action of local anesthetics. Dexmedetomidine is a strong sedative, analgesic, and has anaesthetic properties when used in general anaesthesia.
The purpose of this study was to investigate the difference in postoperative cumulative 24 hour opioid consumption and postoperative analgesia between superficial and deep SAP block in patients undergoing unilateral mastectomy.
|