| CTRI Number |
CTRI/2025/05/087789 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of pain relief effectiveness of two ultrasound guided nerve blocks in breast cancer surgery patients |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided costotransverse foramen block(CTFB) versus modified pectoral nerve block(PECS) in modified radical mastectomy: A Randomised 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 |
Pabitra Kumar Bhanja |
| Designation |
Junior resident |
| Affiliation |
AIIMS, Patna |
| Address |
Department of Anaesthesiology, OT complex, 5th floor, AIIMS Patna, Phulwarisharif, Patna
Bihar
801507
India
Patna
BIHAR
801507
India |
| Phone |
7008286191 |
| Fax |
|
| Email |
pkbhanja11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Anaesthesiology, OT complex, 5th floor, AIIMS Patna, Phulwarisharif, Patna
Bihar
801507
Patna
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajeet Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS,Patna |
| Address |
Department of Anaesthesiology, OT complex, 5th floor, AIIMS Patna, Phulwarisharif, Patna
Bihar
801507
BIHAR
801507
India |
| Phone |
9312501413 |
| Fax |
|
| Email |
ajeetanaes@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Patna, Bihar, India 801507 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Patna |
| Address |
Department of Anaesthesiology, OT complex, 5th floor, AIIMS Patna, Phulwarisharif, Patna
Bihar
801507
India |
| 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 Pabitra Kumar Bhanja |
All India Institute of Medical Sciences,Patna |
Department of Anaesthesiology, OT complex, 5th floor, AIIMS Patna, Phulwarisharif, Patna
Bihar
801507
India
Patna
BIHAR |
7008286191
pkbhanja11@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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costotransverse foramen block |
The Costotransverse Foramen Block technique is meticulously executed with ultrasound precision. Utilizing a 2-5 MHz curvilinear ultrasound probe positioned in the parasagittal plane, we carefully navigate from the lateral to medial aspect while maintaining a consistent parasagittal orientation. This allows us to discern the transition point from ribs to the transverse process and proceed to identify the base of the transverse process (TP) with precision.
Under continuous real-time ultrasound guidance, we employ an in-plane insertion technique using a 22G 100mm echogenic block needle. The needle is skilfully directed in a caudad to cephalad trajectory until it firmly contacts the anteroinferior aspect of the T10 transverse process.
Verification of the needle tips correct placement is accomplished by injecting a small volume (1.5-2ml) of normal saline solution, observing its posterior-to-anterior spread under ultrasound visualization. Once confirmed, we administer 20 ml of 0.2% ropivacaine over 1-2 minutes, ensuring precise delivery while monitoring in real-time using ultrasound guidance
|
| Comparator Agent |
Pectoral nerve block |
The Pectoral Nerve Block procedure is conducted with the patient positioned supine, with the arm abducted. With a meticulous approach, the block is administered on the side of surgery.
Initially, the infraclavicular region is scanned to precisely locate the axillary artery and vein. Subsequently, the ultrasound probe is maneuverer laterally until the pectoralis minor and serratus anterior muscles are identified, typically around the third rib level.
With careful guidance, the needle is inserted obliquely until its tip is visualized between the pectoralis minor and serratus anterior muscles. A solution containing 20 ml of 0.2% ropivacaine is then deposited between these muscles.
Following this, the needle is carefully withdrawn to position its tip between the pectoralis major and minor muscles, where an additional 10 ml of 0.2% ropivacaine is injected.
This method ensures precise localization and delivery of the anaesthetic solution for effective pain management.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
1: Adult female between 18-75 years of age
2: Posted for MRM under GA
3: ASA I and II |
|
| ExclusionCriteria |
| Details |
1: Patient refusal
2: Bleeding disorders
3: Patients on anticoagulant
4: BMI more than or equal to 35 kg/m2
5: Spine/chest wall deformity
6: Sensitivity to LA
7: Pregnancy
8: Inability to understand NRS and PCA device
9: Cureent chronic opiods use |
|
|
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 |
| To compare the postoperative morphine consumption in patients with CTFB vs PECS block in first 24 hours |
24 hours post operatievly |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative fentanyl consumption |
intraoperatively |
| NRS score at 30mins,1,2,4,6,24 hours postoperatively |
24 hours postoperatively |
| Post operative time to 1st rescue analgesia |
within 24 hours postoperatively |
| Patient satisfaction score |
48 hours postoperatively |
| Compare complications |
Intraoperatively |
|
|
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)
|
06/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/06/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In CTFB,10 ml volume of 0.2% ropivacaine will be injected in each space between the T3-T4 and T4-T5 vertebra.
In PECS block, 20 ml volume of 0.2% ropivacaine will be injected between pectoralis minor and serratus anterior muscle followed by 10 ml volume of 0.2% ropivacaine will be injected in between pectoralis major and pectoralis minor muscle. |