| CTRI Number |
CTRI/2019/08/020897 [Registered on: 26/08/2019] Trial Registered Prospectively |
| Last Modified On: |
24/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To assess the efficacy of a block to reduce postoperative pain in breast cancer patients |
|
Scientific Title of Study
|
A clinical study to assess the efficacy of erector spinae plane block for post operative analgesia after modified radical mastectomy in a tertiary care centre |
| Trial Acronym |
|
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepa George |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesiology,Govt TD Medical College,Alappuzha |
| Address |
Department of Anaesthesiology
Govt T D Medical College
Alappuzha
688005
Alappuzha
KERALA
688005
India |
| Phone |
9495918994 |
| Fax |
|
| Email |
drdeepagsaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Deepa George |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesiology,Govt T D Medical College,Alappuzha |
| Address |
Department of Anaesthesiology
Govt T D Medical College
Alappuzha
688005
Alappuzha
KERALA
688005
India |
| Phone |
9495918994 |
| Fax |
|
| Email |
drdeepagsaji@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nanna R Chandran |
| Designation |
Assistant Professor |
| Affiliation |
Department of Anaesthesiology ,Government T D Medical College,Alappuzha |
| Address |
Department of Anaesthesiology
Govt T D Medical College
Alappuzha
688005
Alappuzha
KERALA
688005
India |
| Phone |
|
| Fax |
|
| Email |
nannapratap@yahoo.com |
|
|
Source of Monetary or Material Support
|
| State Branch of Medical Research,Govt T D Medical College,Alappuzha ,Kerala 688005 |
|
|
Primary Sponsor
|
| Name |
Govt T D Medical College |
| Address |
Govt T D Medical College
Alappuzha
688005 |
| 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 Nanna R Chandran |
Govt TD Medical College |
Department of Anaesthesiology,Govt T D Medical College
Alappuzha
688005
Alappuzha
KERALA |
9446386369
nannapratap@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government TD Medical College,Alappuzha |
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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Erector spinae plane block |
Injection to perform the erector spinae plane block under ultrasound guidance using 23 G needle and local anaesthetics (20 ml of 0.25 % bupivacaine and 10 ml of 2 % lidocaine with adrenaline and 8 mg dexamethasone) |
| Comparator Agent |
Subcutaneous infiltration |
Subcutaneous infiltration with 20 ml of 0.25% bupivacaine at end of surgery |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Age group between 25-70 years posted for radical mastectomy
2. ASA 1-4 patients
|
|
| ExclusionCriteria |
| Details |
1.Current or historical evidence of clinically significant medical disease or condition 2.History of allergy to local anaesthetics 3.Refusal of patient to participate in study 4.Psychiatric patients 5.BMI>40
6. Patients with preexisting coagulation abnormalities
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia based on VAS at rest and during arm abduction |
1,2,4,6,12,18,24,30,36,42,48hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Total Fentanyl and vecuronium needed in intraoperative period
2) Total dose of tramadol and paracetamol needed at 24, 48 hours
3) Quality of analgesia based on VAS at rest and arm abduction
4) Quality of analgesia based on VAS at arm abduction .
5) Incidence of side effects like back ache and failure of block or sparing of dermatomes.
6) Incidence of opioid related side effects
|
1,2,4,6,12,18,24,30,36,42,48 hrs |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ultrasound guided erector spinae plane block is a novel analgesic technique in which local anaesthetics is injected into facial plane deep to erector spinae muscle.The drug penetrates anteriorly via costo transverse foramen into the vicinity of origin of dorsal and ventral rami of thoracic nerves and blocking them. The drug spreads in cranial caudal fashion over several levels.These blocks are easy to perform with a potential low risk profile |