| CTRI Number |
CTRI/2026/01/100669 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Improving recovery and a better path to comfort After Breast Cancer surgery- A clinical study which utilizes targeted numbing injection to the chest wall given right after the surgery, and check pain level. |
|
Scientific Title of Study
|
The Efficacy of Post-Procedure PECS Block for Pain Management in Modified Radical Mastectomy. A Prospective Randomized, Double Blinded Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sudi CutyMahlah |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College, Vellore. |
| Address |
Department of Anaesthesiology,Christian Medical College, Vellore.
Vellore TAMIL NADU 632002 India |
| Phone |
8143218138 |
| Fax |
|
| Email |
cutymahlah@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
S Chitra |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore. |
| Address |
Department of Anaesthesiology,Christian Medical College, Vellore.
Vellore TAMIL NADU 632002 India |
| Phone |
9965565990 |
| Fax |
|
| Email |
chitraanaes73@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sudi CutyMahlah |
| Designation |
PG Registrar |
| Affiliation |
Christian Medical College, Vellore. |
| Address |
Department of Anaesthesiology,Christian Medical College, Vellore.
Vellore TAMIL NADU 632002 India |
| Phone |
8143218138 |
| Fax |
|
| Email |
cutymahlah@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid Research Grant, Christian Medical College, Vellore, 632002, Tamil Nadu, India. |
|
|
Primary Sponsor
|
| Name |
Institutional Fluid Research Grant |
| Address |
Christian Medical College
Vellore, 632002, Tamil Nadu, India. |
| Type of Sponsor |
Private 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 |
| DrSudi CutyMahlah |
Christian Medical College, Vellore |
OT COMPLEX, General Surgery, Endocrine Surgery,
Department of Anaesthesiology.
thotapalayam,Vellore,
632002 Vellore TAMIL NADU |
8143218138
cutymahlah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Silver Ethics and Research Committee Christian medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control |
The other group will not receive any block |
| Intervention |
PECS II Block |
Intervention: The block will involve:
Pectoral Nerves: Injecting 10 mL of 0.375% Ropivacaine between the pectoralis major and minor muscles.
Serratus Plane: Injecting 20 mL of 0.375% Ropivacaine deep to the serratus anterior muscle (between the serratus anterior and the intercostal muscles).
Total Volume/Dose: 30 mL of 0.375% Ropivacaine. Group A will receive PECS block intraoperatively by the operating surgeon
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
patients posted for Modified Radical Mastectomy. |
|
| ExclusionCriteria |
| Details |
1.Patient refusal 2. Patient’s history of allergic reaction to local anesthetics 3. Psychiatric or cognitive impairment preventing accurate pain assessment.4. Pre-existing chronic pain or daily opioid use. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assessment of Pain scores at Rest and Movement. |
at rest (0,4,8,12,24) hours
Movement (8,12,24 hours) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time for first rescue analgesia.
2.Total consumption of Rescue Analgesia
|
in first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="6" Days="15" |
|
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
|
Breast cancer is the most common cancer among
women, with surgery being a primary treatment option. A modified radical
mastectomy is a standard procedure. Postoperative pain can significantly impact
quality of life and may lead to chronic pain syndrome. Various nerve blocks,
such as thoracic paravertebral, thoracic epidural, intercostal nerve, and
interscalene brachial plexus blocks, have been utilised for anaesthesia and
pain relief during modified radical mastectomy. However, their use is often
limited due to the complexity of the procedures and the risk of severe
complications.
Recently, there
has been growing interest in a new, less invasive approach known as the
pectoral nerve (PECS) block. The PECS block is an increasingly used regional
anaesthetic technique for postoperative pain management in patients undergoing
breast surgeries, including modified radical mastectomy. It offers a promising
alternative to traditional methods, aiming to reduce post-op pain and improve
patient satisfaction.
The PECS I
block is performed between the pectoralis major and minor muscles, while the
PECS II block adds an injection above the serratus anterior muscle at the third
rib. Studies indicate that administering the PECS block before general
anaesthesia can spread local anaesthetics along fascial planes and limit
electrocautery use, leading to surgical clarity issues. To mitigate these
problems, some surgeons now perform pectoral nerve blocks under direct vision
just before closure to enhance postoperative analgesia in breast surgeries.
|