| CTRI Number |
CTRI/2025/01/079032 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| 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 on Nerve Block for Breast Surgery to Relieve Postoperative Pain |
|
Scientific Title of Study
|
Erector spinae plane block for post operative analgesia in
modified radical mastectomy. A randomised prospective 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 |
Dr Gali Nikhila Naidu |
| Designation |
Post Graduate |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
R.No 105, OT Block, Ground Floor, Kidwai Memorial Institute of Oncology, Dr MH Marigowda Road, Bengaluru, Karnataka India 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9014370465 |
| Fax |
|
| Email |
nikhilanaidug@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Ranganath |
| Designation |
Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
R.No 105, OT Block, Ground Floor, Kidwai Memorial Institute of Oncology, Dr MH Marigowda Road, Bengaluru, Karnataka India 560029
Bangalore
KARNATAKA
560085
India |
| Phone |
9880642830 |
| Fax |
|
| Email |
namrang@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Roopa BO |
| Designation |
Assistant Professor |
| Affiliation |
Kidwai Memorial Institute of Oncology |
| Address |
R.No 105, OT Block, Ground Floor, Kidwai Memorial Institute of Oncology, Dr MH Marigowda Road, Bengaluru, Karnataka India 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
9538860297 |
| Fax |
|
| Email |
dr.roopa.onkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kidwai Memorial Institute of Oncology, Dr MH Marigowda Road, Bengaluru, Karnataka India 560029 |
|
|
Primary Sponsor
|
| Name |
Dr Gali Nikhila Naidu |
| Address |
Post Graduate Womens Hostel, Kidwai Memorial Institute of Oncology, Dr MH Marigowda Road, Bengaluru, Karnataka India 560029 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| DrGali Nikhila Naidu |
Kidwai Memorial Institute of Oncology, Bengaluru |
Department of Anesthesiology and Pain Relief, OT Block Kidwai Memorial Institute of Oncology, Dr MH Marogowda Road, Bengaluru 560029
Bangalore
KARNATAKA |
9014370465
nikhilanaidug@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medical Ethics Committee Kidwai Memorial Institute of Oncology |
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 |
| Intervention |
Erector SPINAE Plane Block with General Anesthesia |
The patient will be placed in a sitting position. The spine will be palpated from C7 downward to T5 and point will be marked to identify the spinous process. After ensuring skin asepsis, we will place the high frequency (5 to 13 MHz) linear probe of ultrasound machine [SonoSite] in a sterile sheath, 2 to 3 cm lateral to the T5 spinous process. The three muscles from outward will be recognized as trapezius, rhomboidus major, and erector spinae muscle.
A 23 G Quincke Babcock spinal needle will be inserted in the plane.
A Total of 25 ml of 0.25% bupivacaine and dexamethasone 4mg will be injected through the needle. The patients will be observed for 30 min after performing the block and general anesthesia will be given. |
| Comparator Agent |
Only General Anesthesia |
Patients will undergo surgery with only general anesthesia. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA I & II patients
2. Patients with Body Mass Index (BMI) between 18.5 and 30 kg per m2
3. Patients who have given consent. |
|
| ExclusionCriteria |
| Details |
1. Patients refusal
2. Repeat surgery, pre existing infection at block site
3. Coagulation disorder
4. Preoperative hypotension (mean arterial BP less than 50 mmHg), Bradycardia (hear rate less than 45 BPM), Dysrhythmia, Psychiatric illness.
5. Pre existing neurological deficits.
6. Known allergy to study drugs.
7. Patients belonging to ASA physical status grade III and IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of Erector spinae plane block for post-operative analgesia in modified radical mastectomy. |
12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time for first rescue analgesia.
2.Total dose requirement of rescue analgesic. |
12 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)
|
01/02/2025 |
| 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="2"
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
|
This is a randomized prospective study evaluating erector spinae plane block for postoperative analgesia in modified radical mastectomy. Patients are allocated into two groups. Group E patients will receive general anesthesia and erector spinae plane block with a total of 25 ml of 0.25% bupivacaine and dexamethasone 4mg through a 23 G Quincke Babcock spinal needle under ultrasound guidance, while Group C patients will receive only general anesthesia. The study’s primary objective is to assess the efficacy of Erector spinae plane block for postoperative analgesia using a visual analog pain score. The secondary objective is to assess the Time for the first rescue analgesia and the Total dose requirement of the rescue analgesic. |