| CTRI Number |
CTRI/2022/11/047142 [Registered on: 09/11/2022] Trial Registered Prospectively |
| Last Modified On: |
07/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief in breast surgery |
|
Scientific Title of Study
|
A randomised control trial comparing the analgesic effects of pectoral nerve block and erector spinae plane block for breast mastectomy surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Divya Sethi |
| Designation |
Associate Professor, |
| Affiliation |
ESIC-PGIMSR, Basaidarapur, New Delhi |
| Address |
Department of Anaesthesia,
2ND FLOOR OT Block,
ESIC-PGIMSR, Basaidarapur, New Delhi
West
DELHI
110063
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Sethi |
| Designation |
Associate Professor, Department of Anaesthesia |
| Affiliation |
ESIC-PGIMSR, Basaidarapur, New Delhi |
| Address |
Department of Anaesthesia, Second Floor Ot block
ESIC PGIMSR
West
DELHI
110015
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Sethi |
| Designation |
Associate Professor, Department of Anaesthesia |
| Affiliation |
ESIC-PGIMSR, Basaidarapur, New Delhi |
| Address |
Department of Anaesthesia, Second Floor Ot block
ESIC PGIMSR
West
DELHI
110063
India |
| Phone |
9891230700 |
| Fax |
|
| Email |
divyasth@gmail.com |
|
|
Source of Monetary or Material Support
|
| ESI-PGIMSR, BASAIDARAPUR, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
ESIPostgraduate Institute of Medical Sciences and Research |
| Address |
BASAIDARAPUR, NEW DELHI |
| 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 DIVYA SETHI |
ESI-PGIMSR, BASAIDARAPUR, NEW DELHI |
2nd and 3rd floor OT block
West
DELHI |
9891230700
divyasth@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: C500||Malignant neoplasm of nipple and areola, (2) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, (3) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae plane block |
A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified superficial to the tip of T7 transverse process. The patients skin will be anesthetized with 2% lidocaine. A 22-gauge 8-cm needle Sonotap needle will be inserted using an in-plane cephalo-to-caudal approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 20 mL of 0.25% Levobupivacaine mixture will be injected after negative aspiration. |
| Intervention |
Modified Pectoral nerve block |
30 ml of 0.25 % levobupivacaine between Pectoralis Minor and Serratus anterior & Pectoralis major and minor under ultrasound guidance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective mastectomy surgery |
|
| ExclusionCriteria |
| Details |
• Patient refusal
• Contraindications to regional anaesthesia
• Known allergy to local anaesthetics
• Bleeding diathesis
• Use of any anti-coagulants
• Patient on chronic analgesics
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total postoperative analgesic consumption |
24hrs after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain assessment: Numeric pain Rating score (NRS) at rest and movement.
Total requirement of rescue analgesia (Fentanyl).
Complications, if any, (will be managed subsequently). |
30min, 2hrs, 4hrs, 6hrs, 8hrs, 24hrs after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
15/11/2022 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT APPLICABLE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients undergoing breast mastectomy surgery experience moderate to severe postoperative pain. In this study, after the patient has been anaesthetised, he/she will be given either a block with local anaesthetic drug under ultrasound guidance in the back muscles or in the front muscles. After the surgery is completed and the effect of anaesthesia is reversed, the patient will be shifted to recovery room, where he/she will be assessed for pain and analgesic requirement. Medications for pain will be administered as per the need of patient. |