| CTRI Number |
CTRI/2025/06/088031 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare effectiveness of 2 different nerve blocks (Serratus posterior superior intercostal plane block and Pectoralis nerve block- PEC II) for pain relief in patients undergoing breast surgery. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of Serratus Posterior Superior Intercostal Plane Block with Pectoralis nerve block (PEC II) in patients undergoing Modified radical mastectomy: A Randomized control 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 |
Ananda Geeta |
| Designation |
Junior Resident |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anesthesiology OT complex 5th floor IPD building AIIMS Patna Phulwari Sharif Patna Bihar
Patna
BIHAR
801507
India |
| Phone |
7010539415 |
| Fax |
|
| Email |
18.anandageeta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anesthesiology OT complex 5th floor IPD building AIIMS Patna Phulwari Sharif Patna Bihar
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonamk@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Patna |
| Address |
Department of Anesthesiology OT complex 5th floor IPD building AIIMS Patna Phulwari Sharif Patna Bihar
Patna
BIHAR
801507
India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonamk@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Phulwari Sharif, Patna, Bihar,India
Pin code:801507
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Anesthesiology OT complex 5th floor IPD building AIIMS Patna Phulwari Sharif Patna Bihar
Pin Code: 801507, |
| Type of Sponsor |
Government 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 |
| Dr Ananda Geeta |
All India Institute of Medical Sciences, Patna |
Department of Anesthesiology OT complex 5th floor IPD building AIIMS Patna Phulwari Sharif Patna Bihar
Patna
BIHAR |
7010539415
18.anandageeta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, AIIMS Patna |
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 |
Pectoralis nerve block (PEC II ) |
Pectoralis nerve block (PEC II) given using 0.25 % Bupivacaine.
1. In between Pectoralis major and Pectoralis minor muscle ( 10 ml)
2. In between Pectoralis minor muscle and Serratus anterior muscle ( 20 ml) |
| Intervention |
Serratus posterior superior intercostal plane block |
Serratus posterior superior intercostal plane block given with 30 ml of 0.25 % Bupivacaine in the fascial plane between Serratus posterior superior muscle and scapula at the level of 2nd and 3rd rib |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
ASA 1 and 2 patients scheduled for Modified Radical Mastectomy |
|
| ExclusionCriteria |
| Details |
1 Patient refusal to participate in the study
2 BMI more than 40
3 Skin lesions or infection at the planned site of needle insertion
4 Inability to understand about the PCA pump
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Requirement of post operative opiod (total dose of Morphine) in 24 hours. |
24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Intraoperative opioid (Fentanyl) consumption.
2 Time of first rescue analgesic administration.
3 Average pain NRS score at 24 h postoperatively period (30 min, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour)
4 Patient satisfaction score
5 Any adverse effect
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
18/06/2025 |
| 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="6"
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
|
Postoperative pain is a
significant concern following Modified Radical Mastectomy (MRM). Pain after MRM
not only causes a strong stress reaction and adverse emotional
experience but also affects postoperative rehabilitation. Hence, different
analgesia techniques, including local anaesthetic infiltration, intercostal
nerve block, paravertebral block, Serratus anterior plane block and thoracic
epidural anaesthesia, have been described to attenuate the intensity of acute
postoperative pain. Paraspinal block and thoracic epidural anaesthesia may
cause parasympathetic symptoms, resulting in hypotension and bradycardia. Additionally, they could lead to general spinal
anaesthesia, local hematoma, infection, anaesthetic poisoning, and paraspinal
muscle pain. Serratus anterior plane block only provides
anterolateral hemi thoracic analgesia and Paravertebral block is associated
with a high risk of complications such as pneumothorax and vascular injury. Serratus
posterior superior intercostal plane block is a novel block that provide
anteroposterior thoracic analgesia. Ultrasound guided Pectoral nerve block (PEC
II) has been the most popular block after breast surgeries because of its ease
of administration and safety. This
randomized controlled trial aims to compare the analgesic efficacy of Serratus
posterior superior block with Pectoral nerve block (PEC II). |