| CTRI Number |
CTRI/2021/06/034133 [Registered on: 10/06/2021] Trial Registered Prospectively |
| Last Modified On: |
28/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different nerve blocks for post operative pain in modified radical mastectomy patients: A double blinded randomized trial |
|
Scientific Title of Study
|
Comparison of mid-point transverse process to pleura (MTP) block and Erector spinae plane block for post-operative pain in modified radical mastectomy patients: A double blinded randomized trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,Jodhpur |
| Address |
Department of anaesthesia and critical care, AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
|
| Fax |
|
| Email |
dr.priyanka_sethi@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,Jodhpur. |
| Address |
Department of anaesthesia and critical care, AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
|
| Fax |
|
| Email |
dr.priyanka_sethi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Sethi |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS,Jodhpur. |
| Address |
Department of anaesthesia and critical care, AIIMS, Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
|
| Fax |
|
| Email |
dr.priyanka_sethi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Priyanka Sethi |
AIIMS Jodhpur (india) |
3rd floor,OT complex,AIIMS
Jodhpur
RAJASTHAN |
09352206300
dr.priyanka_sethi@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committe, AIIMS, Jodhpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
erector spinae plane block |
Group 2 patients will receive ESP block at T3 or 4 level unilaterally on the operative side. Patients will receive 20 ml ropivacaine 0.5%. |
| Intervention |
mid transverse process to pleura block |
Group 1 patients will receive MTP block at T3 or 4 level unilaterally on the operative side.patients will receive 20 ml ropivacaine 0.5%. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
ASA grade 1, 2 and 3
Scheduled to undergo MRM |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Preexisting infection at block site
3. Coagulation Disorder
4. Preoperative hypotension (Mean arterial blood pressure < 50 mmHg), preoperative bradycardia (Heart rate < 45 beats/min) and preoperative dysrhythmia.
5. History of psychiatric illness and preexisting neurological deficits
6. Patient with morbid obesity BMI >40 kg m2
7. Pregnant patients
8. Decreased pulmonary reserve, cardiac disorders and renal dysfunctions
9. Known allergy to study drugs
10. Patient with fungating growth or growth with infection at site of block
11. Patient posted for repeat surgery.
12. Presence of any preoperative pain or history of chronic pain
13. History of regular analgesic use
14. History of pre operative radiotherapy and chemotherapy.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of our study will be to assess visual analogue scale in post operative period for 24 hours. |
The primary outcome of our study will be to assess visual analogue scale in post operative period for 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcome will be to assess and compare duration of analgesia (time to use first rescue analgesic), total amount of rescue analgesic used during 24 hours, duration to perform block, incidence of procedure related complications and postoperative complications, failure rate and patient satisfaction. |
analgesia for next 24 hours at 1hr, 2hr,3 hr,4hr,8hr,12hr,16hr,20 hr and 24 hr post operatively.
satiafcation scors at 24 hours post operatively. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
16/06/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Modified radical mastectomy (MRM) is associated with significant post operative pain and regional anaesthetic techniques are of potential benefit. Erector spinae plane block is a recently described technique for various surgeries at different thoracic levels. A double blinded randomized controlled trial is planned to compare the efficacy of ultrasound guided erector spinae plane block (ESP) with a newer approach to paravertebral block, mid-point transverse process to pleura (MTP) block
Patients belonging to American Society of Anesthesiologists (ASA) physical status grade I,II and III aged between 18 to 75 years and undergoing MRM will be enrolled after informed consent. Two groups will be formed, one for each block. Unilateral block will be given preoperatively at T3 or T4 with 20 ml of 0.5% ropivacaine, catheter will be left in situ and analgesic effect will be assessed post operatively. With routine monitoring patient will be operated under general anaesthesia. Intraoperatively an infusion of 0.5% ropivacaine and post operatively an infusion of 0.2% ropivacaine will be infused at a rate of 5ml/hr. Pain will be assessed based on Visual analogue scale at fixed time intervals and the time of first rescue analgesia will be recorded. It will be a double blinded randomized controlled trial.
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