| CTRI Number |
CTRI/2026/02/103892 [Registered on: 16/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
An observational study to compare two pain relief methods after breast surgery—an intravenous drug and a regional nerve block injection ,to see which one has a longer pain relief effect post surgery |
|
Scientific Title of Study
|
Comparison of Erector Spinae Plane block and Intravenous Dexmedetomidine for postoperative pain relief in patients undergoing breast surgery |
| 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 Simran Shetty |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College , Mangalore |
| Address |
Department of Anesthesiology,
Kasturba Medical College,
Light House Hill Road,
Mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9964741496 |
| Fax |
|
| Email |
simranshetty140199@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ranjan Ramakrishna K |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College , Mangalore |
| Address |
Department of Anesthesiology
Kasturba Medical College,
Light House Hill Road,
Mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9449837154 |
| Fax |
|
| Email |
drranjanrao@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Simran Shetty |
| Designation |
Post graduate student |
| Affiliation |
Kasturba Medical College , Mangalore |
| Address |
Department of Anesthesiology
Kasturba Medical College,
Light House Hill Road,
Mangalore
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9964741496 |
| Fax |
|
| Email |
simranshetty140199@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Simran Shetty |
| Address |
Department of Anaesthesiology
Kasturba Medical College
Light House Hill Road
Mangalore 575 001 |
| 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 |
| Dr Chakrapani M Medical Superintendent |
Kasturba Medical College Hospital Attavar |
Kasturba Medical College Hospital, Nandigudda Road , Attavar , Mangaluru , Karnataka 575001 Dakshina Kannada KARNATAKA |
08242422271
ms.kmchat@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College Mangalore |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
INCLUSION CRITERIA:
1)Female patients aged between 18-75 years
2)Elective mastectomy surgery under general anaesthesia.
3)American society of anaesthesiologists class I - II patients.
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA:
1)Patient refusal.
2)Pregnant patients.
3)Patients with psychiatric diagnosis/cognitive dysfunction
4)Surgical duration more than 6 hrs
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Outcome
1)Duration of post operative analgesia
2)Post operative Visual Analogue scale ( VAS score )
|
1. The data for duration of post operative analgesia and post operative visual analogue scale for each sample will be collected by then end of 24 hrs.
2. Correlation of data will be done after complete data collection - 1 year from the time of ethics committee approval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Requirement of rescue analgesia
2. RSS ( Ramsay Sedation Scale) sedation score
3. Hemodynamic parameters – Heart Rate , Systolic Blood Pressure , Diastolic Blood pressure , Respiratory Rate , Saturation
|
The secondary outcome data for each sample will be collected by the end of 24 hrs.
Correlation of data will be done after complete data collection - 1 year from the time of ethics committee approval |
|
|
Target Sample Size
|
Total Sample Size="74" Sample Size from India="74"
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)
|
15/03/2026 |
| 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="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 dissertation protocol proposes a prospective, comparative observational study to evaluate and compare the effectiveness of the Erector Spinae Plane (ESP) block versus intravenous dexmedetomidine for postoperative analgesia in patients undergoing mastectomy. Given the high incidence of moderate-to-severe acute pain and the risk of chronic post-mastectomy pain syndrome, the study addresses a clear knowledge gap, as both techniques are well studied individually but lack direct head-to-head comparison. The study will be conducted at Kasturba Medical College hospitals and will include ASA I–II female patients aged 18–75 years undergoing elective mastectomy under general anesthesia. A total of 74 patients (37 per group) will be enrolled using convenience sampling. Patients will be allocated to either Group A (ultrasound-guided ESP block at T4 with local anesthetic) or Group B (IV dexmedetomidine loading dose followed by infusion). Standardized general anesthesia will be administered to all patients, and postoperative pain will be assessed using VAS scores at 1, 12, and 24 hours. The primary outcome is postoperative analgesic efficacy, assessed by duration and intensity of pain relief. Secondary outcomes include the requirement for rescue analgesia and comparison of hemodynamic parameters (heart rate, blood pressure, oxygen saturation, respiratory rate), along with monitoring for adverse effects such as hypotension or bradycardia. Data will be analyzed using appropriate parametric or non-parametric tests, with statistical significance set at p < 0.05. Overall, the study aims to determine which modality provides longer-lasting analgesia, reduced need for rescue analgesics, and better hemodynamic stability, thereby guiding optimal postoperative pain management strategies for mastectomy patients. |