| CTRI Number |
CTRI/2021/10/037221 [Registered on: 11/10/2021] Trial Registered Prospectively |
| Last Modified On: |
09/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of two fascial plane block technique for Breast cancer surgery |
|
Scientific Title of Study
|
A comparative evaluation of analgesic efficacy of Serratus anterior with Erector spinae fascial plane block along with General Anaesthesia for Breast cancer 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 Akanksha Gupta |
| Designation |
Junior resident |
| Affiliation |
Institute of medical sciences Sir Sundarlal Hospital Banaras Hindu University |
| Address |
Sir Sundarlal hospital
Department of Anaesthesiology
BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650733863 |
| Fax |
|
| Email |
akank.ggg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nimisha Verma |
| Designation |
Associate professor |
| Affiliation |
Institute of Medical sciences Sir Sundarlal Hospital Banaras Hindu University |
| Address |
Sir Sundarlal Hospital
Department of Anaesthesiology
BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9559955988 |
| Fax |
|
| Email |
verma.nimisha5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nimisha Verma |
| Designation |
Associate professor |
| Affiliation |
Institute of Medical sciences Sir Sundarlal Hospital Banaras Hindu University |
| Address |
Sir Sundarlal Hospital
Department of Anaesthesiology
BHU Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9559955988 |
| Fax |
|
| Email |
verma.nimisha5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh 221005 |
|
|
Primary Sponsor
|
| Name |
None |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Akanksha Gupta |
Sir Sundarlal Hospital Banaras Hindu University |
Department of Anaesthesiology
Surgery oncology Operation theatre
Sir Sundarlal Hospital
Varanasi
UTTAR PRADESH |
9650733863
akank.ggg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of medical sciences, Banaras Hindu University Ethical committee |
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, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector spinae fascial plane block |
USG guided Erector spinae fascial plane block will be given using 0.4ml/kg Ropivacaine 0.25% + 1mcg/kg Fentanyl (max 30ml). Patient will be monitored vigilantly and then taken for General Anaesthesia. If the block is not effective I.e if patient has intra operative tachycardia or hypertension more than 20% from the baseline for more than 5-10mins or if the patient requires intra op Fentanyl then those patients will be excluded from the study. |
| Comparator Agent |
Serratus anterior fascial plane block |
USG guided Serratus anterior fascial plane block will be given using 0.4ml/kg Ropivacaine + 1mcg/kg Fentanyl (max 30ml). Patient will be monitored vigilantly and then taken for General anaesthesia. If the block is not effective I.e if patient has intra operative tachycardia or hypertension more than 20 % from the baseline for more than 5-10mins or if the patient requires intra op Fentanyl then those patients will be excluded from the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1 All female non pregnant patients 18-65 years of age with no comorbidities
2 ASA class I-II
3 BMI < 35kg/m2
4 Having unilateral breast cancer that may or may not involve the axilla |
|
| ExclusionCriteria |
| Details |
1 ASA class lll-Vl
2 BMI>35kg/m2
3 Patient refusal
4 Allergy to ropivacaine or fentanyl
5 Patients undergoing breast reconstruction surgery
6 Prior ipsilateral breast surgery, excluding lumpectomy
7 Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
8 Severe, poorly controlled cardiac and respiratory conditions like arrhythmias, valvular heart diseases, COPD, Interstitial lung disease, poorly controlled asthma
9 Contraindication to regional or general anaesthesia (e.g. bleeding diathesis, coagulopathy, sepsis, infection at the site of potential needle puncture)
10 Pre-existing chronic pain disorder
11 Significant psychiatric disorder that would preclude objective study assessment
11 Pregnancy
12 Unable to provide informed consent
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post op pain scores [Time frame: 24 hours post op] Patients level of post op pain will be evaluated using visual analogue scale (VAS). Range between 0- 10. |
Post op pain scores [Time frame: 24 hours post op] Patients level of post op pain will be evaluated using visual analogue scale (VAS). Range between 0- 10. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1Sensory block onset assessment- pinprick sensation test [Time frame- End of surgical procedure until 24 hours post op]
2 Mean analgesic consumption [Time frame- 24 hours post op] Cumulative I/V Tramadol or PCM 1gm equivalent after surgery
3 Time to first analgesic request [Time frame- 24 hours post op] The time when patient requires first analgesic post op
4 Block related complications [Time frame- End of surgical procedure to 1 month post op] Presence/absence of block related side effects such as bruising, infection, systemic toxicity, persistent numbness
|
1 Sensory block onset assessment- pinprick sensation test [Time frame- End of surgical procedure until 24 hours post op]
2 Mean analgesic consumption [Time frame- 24 hours post op]
3 Time to first analgesic request [Time frame- 24 hours post op]
4 Block related complications [Time frame- Post op to 1 month]
Evaluation to be done @ 24 hours, 7 days and 1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
12/10/2021 |
| 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 yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective randomised interventional parallel group trail where patients will be divided in two groups. We will compare the efficacy of Serratus anterior vs Erector spinae fascial plane block along with General anaesthesia for breast cancer surgery. Also we will assess the decrease in the use of intra operative and post operative analgesics. |