| CTRI Number |
CTRI/2019/08/020751 [Registered on: 16/08/2019] Trial Registered Prospectively |
| Last Modified On: |
05/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of continuous medication versus intermittent medication through regional anaesthetic technique in breast cancer patients undergoing surgery |
|
Scientific Title of Study
|
Comparative evaluation of continuous infusion versus intermittent bolus technique in ultrasound guided Erector Spinae Block in breast cancer patients undergoing modified radical mastectomy surgery- A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Thamizharasan D |
| Designation |
Junior Resident |
| Affiliation |
AIIMS |
| Address |
5th floor,
Department on Anaesthesiology, Pain medicine and Critical care,
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
9566551759 |
| Fax |
|
| Email |
thamizharasan8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Debesh Bhoi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
5th floor,
Department on Anaesthesiology, Pain medicine and Critical care,
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
7042129428 |
| Fax |
|
| Email |
debeshbhoi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Debesh Bhoi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS |
| Address |
5th floor,
Department on Anaesthesiology, Pain medicine and Critical care,
AIIMS
New Delhi
DELHI
110029
India |
| Phone |
7042129428 |
| Fax |
|
| Email |
debeshbhoi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All INDIA INSTITUE OF MEDICAL SCIENCES, NEW DELHI |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
5th floor, Department of Anaesthesiology, Pain Medicine and Critical Care, AIIMS |
| 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 |
| Thamizharasan D |
AIIMS |
Main OT complex, 8 th floor,
Department on Anaesthesiology, Pain medicine and Critical care
East
DELHI |
9566551759
thamizharasan8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C508||Malignant neoplasm of overlappingsites of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Continuous infusion group |
Continuous infusion of 0.2% ropivacaine @ 5 ml/hour through the Erector Spinae catheter for 24 hours.
|
| Comparator Agent |
Intermittent bolus group |
Intermittent bolus dose of 20 ml 0.2% ropivacaine through the Erector Spinae catheter administered every 4 hours for 24 hours.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with breast cancer scheduled for unilateral modified radical mastectomy.
ASA I-II patients.
Patient consenting for study. |
|
| ExclusionCriteria |
| Details |
Patients refusing to participate.
Patients with history of coagulopathy.
Patients on anticoagulant therapy with deranged INR or aPTT values.
Patients with history of known allergy to local anaesthetics and other induction agent drugs.
Patients with local site infection.
Patients with BMI >35 kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Postoperative opioid consumption after Erector Spinae block.
|
At 24hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time to first bolus of rescue analgesic by PCA pump. |
at time of request of rescue analgesic by patient |
| Numeric Pain Rating Scale score |
0,1,2,4,6,12,24 hours |
| Dermatomal sensory mapping |
at 30 minutes and 24 hours after block (by 3 point -scale). |
Intraoperative fentanyl consumption.
|
From induction of anaesthesia to reversal of neuromuscular blockade |
Incidence of Postoperative nausea and vomiting.
|
24 hours |
Assessment of Quality of recovery by QOR-15 questionnaire
|
at 24 hours. |
| Patient satisfaction |
24 hours |
| Catheter related complications |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2019 |
| Date of Study Completion (India) |
25/05/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/05/2021 |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Breast surgery is an exceedingly common procedure and associated with an increased incidence of acute and chronic post surgical pain. Systemic opiods used in analgesia have the disadvantages of nausea, vomiting, respiratory depression and immune depression risking cancer patients to the risk of recurrence. Regional anaesthesia techniques may improve the postoperative analgesia for patients undergoing breast surgery and may even prevent the development of persistent post-surgical pain. Erector Spinae plane block is a recently discovered technique which provides better postoperative analgesia and the technique also lends itself to insertion of an indwelling catheter which can be used to extend the duration of analgesia as needed. After placing the catheter, local anaesthetic will be administered either as continuous infusion or intermittent boluses. However, there is limited literature to support the advantage of one technique over the other. This study hypothesizes that there will be less opioid consumption with intermittent bolus technique compared to continuous infusion technique as intermittent bolus technique is a volume dependent block and there will be wider coverage of required dermatome for analgesia. |