| CTRI Number |
CTRI/2025/08/092613 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare Thoracic Paravertebral block with Modified Pectoral Nerve block in Breast Cancer surgery for post operative pain |
|
Scientific Title of Study
|
Comparative evaluation of ultrasound guided thoracic paravertebral block and modified pectoral nerve block for postoperative analgesia and stress response in patients undergoing 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 Pinki |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no.415 3rd Floor BL Taneja Block Department of Anesthesiology Maulana
Azad Medical College
Central
DELHI
110002
India |
| Phone |
7428050761 |
| Fax |
|
| Email |
pinkylhmc2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lalit Gupta |
| Designation |
Professor |
| Affiliation |
MAULANA Azad Medical College |
| Address |
Room no.415 3rd Floor BL Taneja Block Department of Anesthesiology Maulana
Azad Medical College
Central
DELHI
110002
India |
| Phone |
9868092739 |
| Fax |
|
| Email |
lalit.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pinki |
| Designation |
Post Graduate Student |
| Affiliation |
MAULANA Azad Medical College |
| Address |
Room no.415 3rd Floor BL Taneja Block Department of Anesthesiology Maulana
Azad Medical College
Central
DELHI
110002
India |
| Phone |
7428050761 |
| Fax |
|
| Email |
pinkylhmc2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and associated Lok Nayak Hospital , JLN Marg New Delhi, 110002 |
| 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 Pinki |
Lok Nayak Hospital |
Department of Anesthesiology and intensive care, BL Taneja block, Maulana Azad medical college and associated Lok Nayak Hospital,
Central
DELHI |
7428050761
pinkylhmc2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College |
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 |
Modified Pectoral Nerve Block |
The Modified Pectoral Nerve Block will be the comparator agent. It will be performed as per standard procedure after induction with
the patient in supine position with ipsilateral arm abducted to 90
degrees by an experienced anesthesiologist. The USG probe will be
placed below lateral third of clavicle on operative side.After identification
of axillary vessels probe will be moved inferolaterally until the pectoralis
major,pectoralis minor and serratus anterior muscles are seen in one
plane. A 22-gauge,10cm block needle will be advanced towards the
interfascial plane between pectoralis major and pectoralis minor and a
pre-prepared solution of 10ml of 0.2% ropivacaine with 0.5mcg/kg
dexmedetomidine will be injected. Then probe will be moved towards
axilla till serratus anterior muscle will be identified above third and
fourth ribs and a pre-prepared solution of 20ml of 0.2% ropivacaine with
0.5mcg/kg dexmedetomidine will be injected above the serratus anterior
muscle. After completion of Modified Pectoral Nerve Block(approximate
duration of block administration procedure will be 10 minutes) surgery
will commence. |
| Intervention |
Thoracic paravertebral block |
The paravertebral block will be the intervention agent. it will be performed as per standard procedure after induction with the patient in lateral decubitus position. The USG prob will be placed 2 to 5 cm lateral to the cephalad edge of the fourth thoracic vertebral spinous process to identify the transverse process, pleura and paravertebral space. A 22-gauge, 10 cm echogenic needle will be inserted using an in-plane technique under real-time USG. After visualisation of the superior Costotransverse ligament, a 22-gauge, 10cm echogenic needle will be advanced with in-plane technique craniocaurdly and after frequent aspiration to avoid intravescullar or intrapleural injection. 20ml of 0.2% ropivacaine with 0.5 mcg per kg dexmedetomidine will be injected between the costotransverse ligament and the parietal pleura.After completion of the thoracic paravertebral block(approximate duration of block administration procedure will be 10 minutes) the surgery will commence |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.18 to 65 years of age
2.American Society of Anesthesiologists Physical Status I or II |
|
| ExclusionCriteria |
| Details |
1.History of Neuropsychiatric Disorders
2.Infection at local site
3.Coagulopathies and Thrombocytopenia(platelet count less than 1 lacs)
4.BMI more than 30kg/m2
5.On chronic treatment with opioids
6.Pregnancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to request for 1st supplemental
analgesic requirement post-operatively |
In postoperative period at 0 minutes,30 minutes,2 hours,4 hours,6 hours,12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic changes(Heart Rate and Mean Arterial Pressure)will be
monitored and recorded before induction(baseline),after induction, post block, at skin incision and for every 15 minutes intra-operatively
2.Post-operative NRS score till 24 hours
3.Total amount of analgesic consumption in 24 hours postoperatively
4.Neutrophil Lymphocyte Ratio,Serum Cortisol and Interleukin-6 blood levels
before induction and 6 hours post surgery
5.Patient satisfaction score at 24 hours
6.Block related complications, if any |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
25/08/2025 |
| 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="0"
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
|
We are comparing Thoracic Paravertebral Block with Modified Pectoral Nerve Block for post operative analgesia and stress response in patients posted for Modified Radical Mastectomy in Lok Nayak Hospital Delhi. A total of 32 patients with 16 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. A Preoperative blood sample (total of 3ml) will be taken for analyzing serum cortisol,Neutrophil Lymphocyte ratio and Interleukin-6 blood levels. We will be using standard general anaesthesia for induction of patients following which USG guided block site will be identified and local anesthetic drug will be administered. Patients will be followed up post operatively for 24 hours during which numerical rating scale for pain, time for first supplemental analgesia and total amount of analgesic consumption will be determined. Another blood sample(total of 3ml) will be taken 6 hours post surgery for analyzing serum cortisol, Neutrophil Lymphocyte ratio andInterleukin-6 blood levels. Overall patient satisfaction score will also be assessed.
|