| CTRI Number |
CTRI/2025/08/092311 [Registered on: 04/08/2025] Trial Registered Prospectively |
| Last Modified On: |
01/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Two Types of Nerve Blocks to Reduce Pain After Breast Cancer Sugery. |
|
Scientific Title of Study
|
Comparative Study for Efficacy of Ultrasound Guided Pectoral Nerve Block Versus Erector Spinae Plane Block for Post Operative Analgesia in 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 Anam Danish |
| Designation |
Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9958858369 |
| Fax |
|
| Email |
anam.danish@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shiv Kumar Singh |
| Designation |
Professor |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9650943359 |
| Fax |
|
| Email |
shiv.singh@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anam Danish |
| Designation |
Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9958858369 |
| Fax |
|
| Email |
anam.danish@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| School of Medical Sciences and Research Sharda Hospital Greater Noida Gautam Budhha Nagar Uttar Pradesh 201306 |
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research Sharda Hospital |
| Address |
School of Medical Sciences and Research Sharda Hospital Greater Noida Gautam Buddha Nagar Uttar Pradesh 201306 |
| Type of Sponsor |
Private 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 Anam Danish |
School of Medical Sciences and Research Sharda Hospital |
Block 2F Department of Anaesthesiology Sharda University Knowledge Park III Greater Noida Gautam Buddha Nagar Uttar Pradesh India
Gautam Buddha Nagar
UTTAR PRADESH |
9958858369
anam.danish@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Medical Sciences and Research Sharda University |
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 |
| Comparator Agent |
ERECTOR SPINAE PLANE BLOCK |
GROUP E: In this group the patients will undergo ultrasound guided Erector spinae Plane Block after receiving 25ml 0.25% Inj. levobupivacaine (2.5 mg/ml). The drug will be injected in a single plane at the level of T4. |
| Intervention |
PECTROAL NERVE BLOCK |
GROUP P: In this group the patients will undergo ultrasound guided pectoral nerve block. These patients will receive a total 25 ml of 0.25% Inj. Levobupivacaine (2.5 mg/ml) in which 15 ml will be given between pectoralis minor and serratus anterior muscle. The remaining 10 ml will be given between pectoralis major and pectoralis minor muscle. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA grade 2 AND 3
2. BMI less than 35
3. Patients who are able to understand and rate their Pain on NRS score. |
|
| ExclusionCriteria |
| Details |
1. History of Allergy to Local Anaesthetic
2. Infection at Injection Site
3 Patients On Anti Coagulation therapy
4.Patients with Uncontrolled Hypertension and Diabetes Mellitus
5.Patients who have Renal , Liver or Cardiac Disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare efficacy of post operative pain relief in both groups that is using NRS score. |
24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of requirement for first rescue analgesia in post operative period.
2.Total amount of rescue analgesic consumed in first 24hrs.
3.To record the incidence of post operative nausea and vomiting.
4. To record the incidence of any complications (hematoma, hypotension, pneumothorax) |
24 HOURS POST OPERATIVE PERIOD |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="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
|
This Randomized double Blinded Comparative Studt aims to Compare the Post Operative Analgesic Efficacy of Pectoral Nerve Block and Erector Spinae Plane Block in Patients who will be Undergoing Modified Radical Mastectomy under General Anaesthesia. A Total of 30 Patients of ASA Grade II AND III will be Selected based on the Inclusion and Exclusion Criteria Aged between 18 to 60 years and will be Randomly Assigned into two Groups. Each group will have 15 Patients . Group P : Patients will undergo Pectoral Nerve Block using Inj levobupivacaine 25 ml. Group E : Patients will undergo Erector Spinae Plane Block using Inj Levobupivacaine 25 ML . Primary Objective is to Assess and Compare the Efficacy of Post Operative Pain Relief in both Using NRS Score. Secondary Objectives Include time of Requirement for First Rescue Analgesic , Total amount of Rescue Analgesic Consumed in Post Operative Period, Incidence of Nausea and Vomiting and any Complications like Hypotension and Hematoma. The Patients will be Monitored Intraoperatively and for 24 hours in Post Operative Period. The Study will be Conducted in Sharda Hospital, Greater Noida Over 18 Months. |