| CTRI Number |
CTRI/2024/12/078795 [Registered on: 31/12/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Erector Spinae Plane Block in Breast Surgery |
|
Scientific Title of Study
|
Erector Spinae Plane Block in Breast Surgery: A dose finding 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 Sachin Kumar |
| Designation |
Assistant Professor Anesthesia |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no 5011 5th Floor Anesthesia Office Teaching Block Main AIIMS , Ansari Nagar New Delhi
Room no 5011 5th Floor Anesthesia Office Teaching Block Main AIIMS , Ansari Nagar New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871549343 |
| Fax |
|
| Email |
docsachin.k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sachin Kumar |
| Designation |
Assistant Professor Anesthesia |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no 5011 5th Floor Anesthesia Office Teaching Block Main AIIMS , Ansari Nagar New Delhi
Room no 5011 5th Floor Anesthesia Office Teaching Block Main AIIMS , Ansari Nagar New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871549343 |
| Fax |
|
| Email |
docsachin.k@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachin Kumar |
| Designation |
Assistant Professor Anesthesia |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no 5011 5th Floor Anesthesia Office Teaching Block Main AIIMS , Ansari Nagar New Delhi
Room no 5011 5th Floor Anesthesia Office Teaching Block Main AIIMS , Ansari Nagar New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9871549343 |
| Fax |
|
| Email |
docsachin.k@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 5011 Anesthesia Office 5th floor Teaching Block Main AIIMS Ansari Nagar New Delhi Pin -110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Room no 5011 Anesthesia Office 5th floor Teaching Block Main AIIMS Ansari Nagar New Delhi Pin -110029 |
| Type of Sponsor |
Government 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 Sachin Kumar |
AIIMS New Delhi |
Rom no 5011, 5th Floor Teaching Block Main AIIMS New Delhi
New Delhi
DELHI |
9871549343
docsachin.k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS NEW DELHI |
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 |
Drug Volume Change |
We will increase or decrease the volume of local anesthetic ropivacaine by 3 ml depending on the response in previous patient till 6 hours of performance of the block using biased coin-up- and-down study design. |
| Comparator Agent |
Response in previous patient |
Biased coin-up-and-down study design will be used and dose in the previous patient will be seen till the 6 hours of the performance of the block and decided accordingly |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. All ASA I to ASA III patients undergoing Modified Radical Mastectomy.
2. Average Indian female height (148-160 cm).
|
|
| ExclusionCriteria |
| Details |
1. Patients under the age of 18.
2. Allergy to local anesthetics.
3. Analgesic treatment taken within 12 h before surgery.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this study is to estimate the MEV90 (Minimum effective volume) of Ropivacaine 0.375% for Erector Spinae Plane Block for patients undergoing breast surgery. |
just after surgery, 30 min , 1 hour ,2 hour,3 hour,4 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To look for satisfaction score in patients with successful block |
6 hours after the performance of block |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Erector Spinae Plane block is performed for post operative pain control in Breast Surgery.This block has been used in different volumes by different investigators. Specific volume for a particular concentration of local anesthetic is yet to be found.We are conducting a dose finding study with .375% ropivacaine in erector spinae plane block.A unilateral ESPB will be performed before the induction of general anaesthesia at the level of T4 vertebra under USG guidance. Patient giving consent for the study will be taken to procedure room. Iv line will be secured and routine ASA monitors will be attached. ESP block will be given before giving general anesthesia to the patient. After the needle tip will be correctly placed in the ESP using an ‘in-plane’ technique, a widespread application of 15 to 30 ml of a predefined dose of ropivacaine 0.375% will be injected. Two experienced investigators will administer ESPB to avoid the bias of having only one physician performing all of the blocks. Investigators performing the ESPB will neither be involved in the management of the general anaesthesia nor in the postoperative care and the pain assessment of the patients. Patients will be blinded to the volume of ropivacaine injected. To assess the ropivacaine MEV90, we will use up-and down sequential allocation method. The dose of ropivacaine received by the subsequent patients will be determined by the response of the previous patient. For successful responses, the volume will be reduced by 3mL, and for unsuccessful responses, the next patient will receive a dose increased by 3mL. General anaesthesia will be induced with fentanyl 2mcg/kg, propofol 2mg/kg and atracurium 0.5mg/kg. Anaesthesia will be maintained with isoflurane (MAC 1). During the surgical procedure, fentanyl (1mcg/kg) will be given if the heart rate or arterial pressure increased by 20% relative to the baseline measurement. All the patients will receive 1gm paracetamol after induction intraoperatively. The success or failure of the study dose of ropivacaine will be assessed using the NPS at rest 30min after arrival to the recovery room. Two outcomes will be considered; effective: NPS of 3 or lower out of 10 (directing a decrement for the next patient); and ineffective: NPS greater than 3 out of 10 (directing an increment for the next patient). In case of NPS greater than 3 out of 10 within the 6 h of the study, the dose will be considered ineffective, and the patient will be given rescue analgesia. Injection Fentanyl 0.5 mcg/kg will be used as rescue analgesic if NPS > 3 at any time postoperatively. Study end point will be 6 hours after performance of the block. After shifting to post anesthesia care unit pain score and patient satisfaction score will be noted every 30 minutes till study end end point is reached. |