CTRI Number |
CTRI/2023/07/055300 [Registered on: 17/07/2023] Trial Registered Prospectively |
Last Modified On: |
17/07/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
Public Title of Study
|
A comparison of quality of recovery after erector spinae block given with 20ml vs 30 ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy. |
Scientific Title of Study
|
A randomized double blind study comparing quality of recovery after erector spinae block given with 20ml vs 30ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy. |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Nirakar Pahadi |
Designation |
DNB trainee |
Affiliation |
Tata Main Hospital , Jamshedpur |
Address |
Dept of Anaesthesiology , Tata Main Hospital , Jamshedpur Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001 Purbi Singhbhum JHARKHAND 831001 India |
Phone |
9040143917 |
Fax |
|
Email |
nirakarpahadi190@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Srividhya |
Designation |
Senior Consultant |
Affiliation |
Tata Main Hospital , Jamshedpur |
Address |
Dept of Anaesthesiology , Tata Main Hospital , Jamshedpur Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001 Purbi Singhbhum JHARKHAND 831001 India |
Phone |
7763807752 |
Fax |
|
Email |
drsrividhya@tatasteel.com |
|
Details of Contact Person Public Query
|
Name |
Dr Srividhya |
Designation |
Senior Consultant |
Affiliation |
Tata Main Hospital , Jamshedpur |
Address |
Dept of Anaesthesiology , Tata Main Hospital , Jamshedpur Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001 Purbi Singhbhum JHARKHAND 831001 India |
Phone |
7763807752 |
Fax |
|
Email |
drsrividhya@tatasteel.com |
|
Source of Monetary or Material Support
|
TATA MAIN HOSPITAL , JAMSHEDPUR |
|
Primary Sponsor
|
Name |
Tata Main Hospital |
Address |
Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001 |
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 |
Nirakar Pahadi |
Tata Main Hospital |
Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001 Purbi Singhbhum JHARKHAND |
9040143917
nirakarpahadi190@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE , Tata Main Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Different volume of Ropivacaine 0.375% |
In this arm general anaesthesia will be induced and after giving erector spinae plane block 30ml of 0.375% Ropivacaine will be administered. |
Intervention |
ERECTOR SPINAE PLANE BLOCK |
In this arm general anesthesia will be induced and after giving erector spinae plane block 20ml of 0.375% Ropivacaine will be administered. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Female |
Details |
ASA grade 1 to 3.
Patients undergoing single side modified radical mastectomy for breast cancer. |
|
ExclusionCriteria |
Details |
Patients refusing to participate in study.
Bilateral breast surgery.
Patients with allergy to local anesthetics.
Patients with coagulopathy , infection at site of block and patients with neurological deficits.
Patients on anti depressants or psychiatric drugs.
Patients previously on pain medication. |
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Mean QoR (Quality of Recovery) 40 Score |
24 HOURS |
|
Secondary Outcome
|
Outcome |
TimePoints |
Mean 24 hours VAS score.
Mean opioid consumption in first 24 hours post operatively.
Duration of block (Time of administration of block to first dose of rescue analgesic). |
0, 30, 60, 90 minutes and then 2, 4, 6, 12, 16, 20 and 24 hours. |
|
Target Sample Size
|
Total Sample Size="98" Sample Size from India="98"
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)
|
28/07/2023 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
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 is one of the most frequently practiced surgery . In MRM there is substantial dissection of nerve fibres. so, post op analgesia is difficult to provide. The incidence of post mastectomy pain syndromes is 20-60%. Quality of recovery after the surgery becomes an important parameter for a good postoperative outcome. One of the components of quality of recovery is good post operative pain management . Regional anaesthesia in the form of fascial blocks have taken the lead in this field. Erector Spinae Block - decreases acute post op pain, improve the quality of recovery in patients undergoing MRM surgeries. Research question: Is the quality of recovery (QoR 40 Score) better when erector spinae plane block is given with 20ml of 0.375% Ropivacaine as compared to 30 ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy? Objectives: Primary objective is to compare patient improvement with Quality of Recovery 40 (QoR 40) day after surgery. Secondary objective is 24 - hour postoperative pain scores (VAS) , post operative opioid consumption, time of first dose of rescue analgesic . Methodology: Randomized Prospective Double blind study from 1.04.23 – 31.10.24 at Tata Main Hospital, Jamshedpur. Randomization will be done by computer generated random number. Blinding: the patient will be blind to the volume of drug used. Also, the person collecting the data and analyzing in the postoperative period will be different from the person doing the ESP Block. First GA will be administered with IV Fentanyl 2 mcg/kg, Propofol 2.5mg/kg, Vecuronium 0.1mg/kg at induction & ET intubation . After that patient is shifted to lateral position and a Single shot ESP block – US guided 13-6 Mhz (Sonosite M turbo), at T4 level using 100mm 20G USG needle (Stimuplex Ultra 360) is done . A volume of 0.375% Ropivacaine according to the group assigned is administered. Blocks will be performed by an anaesthesiologist who has previously done 25 or more ESPB before the commencement of study. Group A - patients will receive ultrasound guided ESPB with 20 ml of 0.375% Ropivacaine of along with general anaesthesia . Group B – patients will receive ultrasound guided ESPB with 30 ml of 0.375% Ropivacaine along with general anaesthesia. Patient is made Supine and 60 minutes after induction – Morphine 0.1 mg/kg IV is given. Maintenance in the form of O2/N2O, Vecuronium, Isoflurane is administered. Paracetamol 1gm IV half hour before end of surgery and 8 hourly postop and rescue analgesia in the form of Injection Tramadol 1.5 mg/kg when VAS≥4 is administered. Observations in the form of QoR - 40 Score (using QoR-40 Recovery Assessment Format), VAS score at 0,30,60,90(mins) 2 hours, 4,6,12,16,20,24 hours , time of first rescue analgesic, total requirement of opioid in first24 hours and vital parameters – HR, SBP, DBP, MAP, SpO2 ( Baseline, at induction, 5 minutes for first 10 mins and 10 mins till end of surgery will be recorded. Complications in the form of pnuemothorax, intramuscular Injection, bleeding will be recorded. Outcome variables will be: mean QoR 40 Score, mean 24hour VAS score, mean opioid consumption in first 24 hours post operatively, duration of block ( Time of administration of block to first dose of rescue analgesic). |