CTRI Number |
CTRI/2018/04/012915 [Registered on: 02/04/2018] Trial Registered Prospectively |
Last Modified On: |
11/06/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two pain reducing techniques after breast cancer surgery. |
Scientific Title of Study
|
Comparison of efficacy of Ultrasound guided Paravertebral Block versus Erector Spinae Plane block for Postoperative Analgesia in Modified Radical Mastectomy : 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 |
Dr Shilpi Agarwal |
Designation |
Senior Resident |
Affiliation |
AIIMS , NEW DELHI |
Address |
Department of Onco Anaesthesia and Palliative Medicine,
DR BRAIRCH,
AIIMS;
New Delhi
South DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drshilpi87@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sachidanand Jee Bharati |
Designation |
Associate Professor |
Affiliation |
AIIMS , NEW DELHI |
Address |
RN 139 , 1st Floor,
Department of Onco Anaesthesia and Palliative Medicine,
DR BRAIRCH,
AIIMS;
New Delhi
South DELHI 110029 India |
Phone |
9968436042 |
Fax |
|
Email |
sachidadr@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Shilpi Agarwal |
Designation |
Senior Resident |
Affiliation |
AIIMS , NEW DELHI |
Address |
Department of Onco Anaesthesia and Palliative Medicine,
DR BRAIRCH,
AIIMS;
New Delhi
DELHI 110029 India |
Phone |
|
Fax |
|
Email |
drshilpi87@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
AIIMS |
Address |
AIIMS , New Delhi - 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 Shilpi Agarwal |
AIIMS , New Delhi |
RN 139 ,1st Floor , Deparment of Onco-Anaesthesia and Palliative Medicine, DRBRAIRCH,AIIMS ,New Delhi South DELHI |
9650797105
drshilpi87@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Aiims |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Patients with breast cancer, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Group E |
Ultrasound guided Erector spinae plane block will be given at T5 level along with general anaesthesia in MRM |
Comparator Agent |
Group P |
Ultrasound guided Paravertebral block will be given at T4 level along with general anaesthesia in MRM |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Female |
Details |
1. ASA I and II
2. Patients posted for MRM
3. Patients giving written informed consent to participate in the study
|
|
ExclusionCriteria |
Details |
1. Patient refusal
2. Age <18 or > 70 years
3. Patients with BMI > 35kg/m2
4. Patient with infection at the site of injection
5. Coagulopathy
6. Spine deformity
7. Drug addicts or history of opioid dependence
8. Patients with history of allergy to opioids or local anaesthetics
|
|
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 measure the duration of post-operative analgesia (that is, time to first analgesic request from the time of giving block ).
|
Pain assessment would be done in immediate post (0 min), 30 min, 1 hr , 2hr , 6hr, 12 and 24 hr. |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Total rescue analgesic requirement in postoperative period.
2) To evaluate patient satisfaction in postoperative period.
|
Patient satisfaction would be evaluated at 24 hrs after surgery |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
20/04/2018 |
Date of Study Completion (India) |
16/05/2019 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NA |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Acute postoperative pain due to insufficient pain control is a major risk factor for development of chronic pain after breast surgery. Regional anaesthesia is considered protective for cancer recurrence by its direct and indirect anti proliferative effects. Use of these techniques is associated with better pain control , decreased opioid consumption and their side effects. Paravertebral block is a established regional anaesthesia and analgesia technique for breast cancer surgeries.However erector spinae plane block is a novel interfacial block technique which can be a viable alternative to paravertebral block due to its fast , easy and safe execution . There are numerous studies on paravertebral block but there is a very limited literature on erector spinae plane block in breast surgeries and there is no study comparing paravertebral block with erector spinae plane block in breast surgeries.Thus we are performing this randomized controlled trial to compare the efficacy of paravertebral block with erector spinae plane block in breast surgeries in total 80 patients ( 40 in each group). In Group P , ultrasound guided paravertebral block will be given at T4 level with 20 ml of 0.5 % Ropivacaine and in Group E , ultrasound guided erector spinae plane block will be given at T5 level with 20 ml of 0.5 % Ropivacaine. After giving the block , GA will be given.Any block related complications will be noted. In postoperative period the efficacy of both the blocks will be compared in terms of duration of postoperative analgesia (time to first rescue analgesic ) , total number of rescue analgesics required and patient satisfaction . |