| CTRI Number |
CTRI/2025/09/095019 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study in Adult Women Undergoing Breast Cancer Surgery to Compare Pain Relief from Erector Spinae Plane Block Using Ropivacaine with Dexmedetomidine Versus Ropivacaine Alone |
|
Scientific Title of Study
|
EFFICACY OF ERECTOR SPINAE PLANE BLOCK
USING ROPIVACAINE-DEXMEDETOMIDINE
COMBINATION VERSUS ROPIVACAINE ALONE IN
ADULT FEMALES UNDERGOING BREAST
ONCOSURGERY –A RANDOMIZED CONTROLLED 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 |
Dr Anjali Gera |
| Designation |
Senior consultant |
| Affiliation |
Sir Ganga Ram Hospital, New Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine,Sir Ganga Ram hospital, New Delhi-110060, INDIA
Institute of Anaesthesiology, Pain and Perioperative Medicine,
Sir Ganga Ram hospital, New Delhi-110060, INDIA
Central
DELHI
110060
India |
| Phone |
9811571080 |
| Fax |
|
| Email |
anjali_chawla@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anjali Gera |
| Designation |
Senior consultant |
| Affiliation |
Sir Ganga Ram Hospital, New Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine,Sir Ganga Ram hospital, New Delhi-110060, INDIA
Institute of Anaesthesiology, Pain and Perioperative Medicine,
Sir Ganga Ram hospital, New Delhi-110060, INDIA
Central
DELHI
110060
India |
| Phone |
9811571080 |
| Fax |
|
| Email |
anjali_chawla@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunjeet kaur |
| Designation |
Post diploma DNB trainee |
| Affiliation |
Sir Ganga Ram Hospital, New Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine, Sir Ganga Ram Hospital, New Delhi-110060, INDIA
Institute of Anaesthesiology, Pain and Perioperative Medicine,
Sir Ganga Ram hospital, New Delhi-110060, INDIA
Central
DELHI
110060
India |
| Phone |
8054181819 |
| Fax |
|
| Email |
gunjeetkaur983@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir Ganga Ram Hospital, New Delhi |
|
|
Primary Sponsor
|
| Name |
Sir Ganga Ram Hospital, New Delhi |
| Address |
Institute of Anaesthesiology, Pain and Perioperative Medicine,3rd floor Block E,
SGRH, Old Rajinder Nagar, New Delhi-110060, 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 Anjali Gera |
Sir Ganga Ram Hospital |
OT-4,3rd Floor Block E, Sir Ganga Ram Hospital, New Delhi, 110060, INDIA
Central
DELHI |
9811571080
anjali_chawla@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, Sir Ganga Ram Hospital |
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 |
ERECTOR SPINAE PLANE BLOCK USING ROPIVACAINE ALONE |
ERECTOR SPINAE PLANE BLOCK WILL BE GIVEN UNDER ULTRASOUND GUIDANCE BEFORE EX USING ROPIVACAINE ALONE |
| Intervention |
ERECTOR SPINAE PLANE BLOCK USING ROPIVACAINE-DEXMEDETOMIDINE COMBINATION |
ERECTOR SPINAE PLANE BLOCK WILL BE GIVEN UNDER ULTRASOUND GUIDANCE BEFORE EXTUBATION OF THE PATIENT USING ROPIVACAINE-DEXMEDETOMIDINE COMBINATION |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. 18-65 years
2. ASA physical status I, II, III |
|
| ExclusionCriteria |
| Details |
1. Anomalies of vertebral column
2. Any lesion obscuring Sono anatomy of injection site
3. History of allergy to study drugs
4. Patient not consenting to participate in the study |
|
|
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 |
| Post-operative pain assessed using VAS score |
Postoperatively at 30 mins, 2 hr, 4 hr, 6 hr,12 hr,24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total rescue analgesics dose requirements
2. Post-operative nausea and vomiting
3. Patient satisfaction
4. Post-operative sedation
5. Hemodynamic instability |
30 minutes, 2 hours, 4 hours, 6 hours, 12 hours and 24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="6"
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
|
Breast cancer is the most commonly diagnosed cancer in women in India as per the National Cancer Registry Programme (NCRP) 2020 report by the Indian Council of Medical Research making Modified Radical Mastectomy (MRM) and flap reconstruction, the most commonly performed surgeries. MRM is usually done under general anesthesia (GA) using intravenous opioids but the incidence of moderate to severe postoperative pain after mastectomy under GA is high. ESP (Erector Spinae Plane) block in breast surgeries has been found to effectively reduce post operative pain and opioid consumption. Bupivacaine, a long-acting amide local anaesthetic, has been widely utilized in ESP blocks, demonstrating consistently favourable outcomes in terms of pain control and opioid-sparing effects. Ropivacaine, a long-acting amide local anaesthetic is an alternative to Bupivacaine and has superior cardiovascular safety profile with comparable analgesic efficacy. Structurally similar to Bupivacaine but less lipophilic, Ropivacaine has a lower propensity for central nervous system and cardiac toxicity, making it particularly suitable for patients with cardiovascular risk factors. Duration of analgesia with Ropivacaine alone is around 10-12 hours, Dexmedetomidine acts synergistically with LA (Local Anaesthetics) by prolonging the duration of sensory blockade, reducing nociceptive transmission, and attenuating central sensitization. Its analgesic properties contribute to reduced opioid requirements and improved patient comfort without significant respiratory depression. |