| CTRI Number |
CTRI/2026/01/102049 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
24/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison of Regional Nerve Block and Morphine for Postoperative Pain Relief Following Breast Cancer Surgery |
|
Scientific Title of Study
|
COMPARISION OF POST-OPERATIVE ANALGESIA
USING ULTRASOUND GUIDED ERECTOR SPINAE
PLANE BLOCK VERSUS INTRAVENOUS MORPHINE
AND LOCAL ANAESTHETIC WOUND
INFILTRATION 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 |
DrKUMAR VAIBHAV GAUTAM |
| Designation |
PG Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung hospital,Ansari Nagar East,New Delhi
South
DELHI
110029
India |
| Phone |
8920581848 |
| Fax |
|
| Email |
krvaibhavgautam.998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrNishtha Kachru |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung hospital,Ansari Nagar East,New Delhi
South
DELHI
110029
India |
| Phone |
9958844229 |
| Fax |
|
| Email |
kachnishtha98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNishtha Kachru |
| Designation |
Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung hospital,Ansari Nagar East,New Delhi
DELHI
110029
India |
| Phone |
9958844229 |
| Fax |
|
| Email |
kachnishtha98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhaand Safdarjung hospital,Ansari Nagar East,New Delhi
|
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung hospital |
| Address |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung hospital,Ansari Nagar East,New Delhi |
| 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 KUMAR VAIBHAV GAUTAM |
Vardhman Mahavir Medical College and Safdarjung hospital |
Department of Anaesthesia and Intensive care,VMMC and Safdarjung hospital,Ansari Nagar East,New Delhi
South
DELHI |
8920581848
krvaibhavgautam.998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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, (2) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
20 ml of 0.25% Bupivacaine for Erector spinae plane block in MRM surgery. |
| Comparator Agent |
intravenous morphine |
Injection 0.1mg/kg i.v.morphine is given in 2nd group.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Adult female patients aged between 18-65 years with ASA(American Society of
Anaesthesiologists) grade between I-III who are posted for elective modified radical
mastectomy under general anaesthesia are included. |
|
| ExclusionCriteria |
| Details |
The patients with the following preoperative conditions will be excluded from the study:
1. Contraindication to nerve block(coagulopathies/on anticoagulants/ local site infection)
2. Patients who will be known cases of CKD, and COPD.
3. Pregnancy
4. Patients with spinal anomalies.
5. Drug allergy.
6. Patients who have cognitive disability and are unable to understand the NRS score. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the post-operative analgesic efficacy of ultrasound guided erector spinae block
with intraoperative intravenous morphine followed by local anaesthetic infiltration at the
incision site in patients undergoing modified radical mastectomy using Numerical Rating
Scale(NRS) at 4 hours. |
4 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the amount of additional analgesia required over 24 hours in both groups.
2. To compare postoperative analgesia duration(time to first rescue analgesia) in first 24
hours in both groups. |
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
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2026 |
| 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="1"
Months="6"
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
|
This study aims to fill the gap in literature evaluating post-operative analgesia using ultrasound guided erector spinae plane block versus intravenous morphine followed by local anaesthetic wound infiltration in patients undergoing modified radical mastectomy. |