| CTRI Number |
CTRI/2024/03/064565 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of severity of pain of multiple local anaesthetic nerve blocks and intravenous painkillers for breast surgery |
|
Scientific Title of Study
|
Comparison of analgesic efficacy (intra and post operatively) of ultrasound guided Erector spinae plane block, Serratus anterior plane block, Paravertebral plane block and intravenous opioids for modified radical mastectomy- A prospective randomised 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 |
DrDIVYA DHARSHINIVP |
| Designation |
Post graduate resident |
| Affiliation |
NARAYANA HRUDHAYALAYA LTD. |
| Address |
Room no 42
Anaesthesia clinic
Mazumdhar Shah medical centre
Narayana health City Bommasandra
Bangalore Rural
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9790618482 |
| Fax |
|
| Email |
ddharshini.3105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HARISH |
| Designation |
consultant |
| Affiliation |
NARAYANA HRUDHAYALAYA LTD. |
| Address |
Room no 42
Anaesthesia clinic
Mazumdhar Shah medical centre
Narayana health City Bommasandra
Bangalore Rural
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9449000426 |
| Fax |
|
| Email |
drmaama@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrDIVYA DHARSHINIVP |
| Designation |
Post graduate resident |
| Affiliation |
NARAYANA HRUDHAYALAYA LTD. |
| Address |
Room no 42
Anaesthesia clinic
Mazumdhar Shah medical centre
Narayana health City Bommasandra
Bangalore Rural
Bangalore Rural
KARNATAKA
560099
India |
| Phone |
9790618482 |
| Fax |
|
| Email |
ddharshini.3105@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NARAYANA HRUDHAYALAYA |
| Address |
Mazumdhar Shah medical centre
Unit of Narayana Hrudhayalaya
Narayana health city
Bommasandra
Bangalore - 560099
|
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| DIVYA DHARSHINI V P |
NARAYANA HRUDHAYALAYA |
Room no.42
Anaesthesia clinic
Mazumdhar Shah medical centre
Unit of Narayana Hrudhayalaya
Narayana health city
Bommasandra
Bangalore Rural
KARNATAKA |
9790618482
ddharshini.3105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana health academic ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C501||Malignant neoplasm of central portion of breast, (2) ICD-10 Condition: C503||Malignant neoplasm of lower-innerquadrant of breast, (3) ICD-10 Condition: C505||Malignant neoplasm of lower-outerquadrant of breast, (4) ICD-10 Condition: C502||Malignant neoplasm of upper-innerquadrant of breast, (5) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae plane block |
Under ultrasound guidance and patient in lateral position, Erector spinae plane block will be given with 0.3ml/kg of 0.25% BUPIVACAINE at the level of T5 vertebra above the transverse process shadow 2-3 cm from midline. |
| Comparator Agent |
Intravenous opioids |
1mcg/kg will be given every hour for all patients. |
| Comparator Agent |
Paravertebral plane block |
With ultrasound guidance, patient in lateral position,0.3ml/kg of 0.25% BUPIVACAINE is injected into the paravertebral plane. |
| Intervention |
Serratus anterior plane block |
Under ultrasound guidance,with patient in supine position and arm abducted to 90 degrees,0.3 ml/kg of 0.25% BUPIVACAINE is injected in plane between muscle and rib (at the level of 4th and 5th rib) in midaxillary line. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1.More than 18 years with breast cancer
2.American society of anesthesiologists physical status I to III.
3.patients who have given informed written consent. |
|
| ExclusionCriteria |
| Details |
Body mass index more than 40
Local anaesthetic allergy
Local infection at the site of block
Respiratory or neurological disease. |
|
|
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 |
| To document and compare cumulative opioid consumption intraoperatively and 24 hours postoperatively in all 4 groups |
To document and compare cumulative opioid consumption intraoperatively and 24 hours postoperatively in all 4 groups |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Time of first rescue analgesic
2.Interval between opioid doses.
3.NRS score at rest,6,12,18,24 hours.
4.Complications of each technique
5.Postoperative nausea and vomiting
6.Hemodynamics |
During surgery and 24 hours post surgery. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
10/04/2024 |
| 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="0"
Months="6"
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
|
Post-mastectomy pain is a big problem affecting the outcome of surgery which is usually managed by analgesics associated with side effects such as nausea, vomiting, sedation and respiratory depression. Therefore, for effective pain control with minimal side effects, many regional analgesic techniques have been developed which have better hemodynamic stability, early ambulation, reduced hospital stay duration postoperatively. This current study will be undertaken to compare the effectiveness of 3 techniques Erector Spinae plane block (ESPB), Serratus anterior plane block (SAPB) and Paravertebral plane block (PVPB) with intravenous analgesics especially opioids being control group following breast surgery. |