| CTRI Number |
CTRI/2024/02/062325 [Registered on: 06/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| 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 Enhanced Recovery After Surgery (ERAS) protocol with conventional care in patient’s understanding Modified Radical Mastectomy for Carcinoma breast |
|
Scientific Title of Study
|
Comparison of Enhanced Recovery After Surgery (ERAS) protocol with
Conventional Care in patients undergoing Modified Radical Mastectomy
for carcinoma breast- a Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Shivanand Hosamani |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9591565080 |
| Fax |
|
| Email |
shosamani87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Balamourougan K |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443617089 |
| Fax |
|
| Email |
drbalak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Balamourougan K |
| Designation |
Additional professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9443617089 |
| Fax |
|
| Email |
drbalak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar, |
| 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 |
| DR SHIVANAND |
jipmer |
Jawaharlal Institute of Postgraduate Medical Education and Research
JIPMER Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006.
Pondicherry
PONDICHERRY |
9591565080
shosamani87@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONL STUDIES |
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
|
| Type |
Name |
Details |
| Intervention |
-To study the effect of ERAS protocol on patient undergoing modified radical mastectomy |
In the ERAS group, the management protocol includes the following.
During the pre-operative period, counseling will be given by investigators on the day before surgery regarding multimodal pain control methods and peri-operative expectations.
Clear fluids up to 2 hours before surgery.
Preoperative carbohydrate loading 100 gm of dextrose in 400ml of water the night before surgery and 50mg in 200ml of water 2 hours before surgery.
Preoperative Paracetamol 1 gram + 75 mg of Pregabalin 2 hours before surgery
Injection Ondansetron 8 Mg 2 hrs before surgery
Preoperative prophylactic antibiotics, Injection Augmentin 1.2 gms half an hour before incision.
Intra operative euvolemic will be maintained by crystalloids at 2 ml/ kg. normothermia will be maintained
Intra operative minimal use of sevoflurane ( end tidal sevo 1.5%), oxygen in air
Preoperative Pecs 1 and Pecs 2 block after induction of anesthesia before incision percutaneous or intraoperative Pectoral block, given at the end of surgery
Injection Dexamethasone 8mg at the beginning+Injection Ondansetron 4mg at the end of surgery
15 mg of intravenous ketorolac during closure of incision
Early cessation of intravenous fluid. Orals(clear fluids) will be started 2 hours after surgery or on demand by patient, and if
tolerated will be escalated to solid diet. IV fluids will be stopped once orals is tolerated.
Early ambulation on the same evening with assistance. Patient will be encouraged to do 4-8 walks daily from POD 1.
Injection Paracetamol 1gm/IV 8TH hourly for the first 48 hours and injection Tramadol 50 mg IV SOS will be given postoperatively.
If post-operative pain by VAS score 4 Inj. Morphine /tramadol / fentanyl will be given as rescue analgesics.
|
| Comparator Agent |
Conventional Care in patients undergoing Modified Radical Mastectomy for carcinoma breast |
in control group
Overnight fasting from 10 PM.
No preoperative antibiotics are given
Inhalational based with isoflurane
Premedication with diazepam 0.1mg/kg, no preincision blocks, induction with fentanyl 2 mcg/kg, propofol 1 to 2 mg/kg till loss of response to verbal command,anesthesia maintenance with oxygen,nitrous oxide, isoflurane with Fio2 35% and MAC of 1, end operatively will receive ondansetron, intraoperative supplementation analgesia with IV fentanyl 0.5 mcg/kg if hemodynamics 20% of baseline. Fluids as per Holiday Segar formula.
20 ml of 0.25% Bupivacaine will be given as Wound infiltration at the time of skin closure.
Post operative analgesics like injection paracetamol 1gm 8th hourly and injection tramadol 50mg iv SOS hourly will be given postoperatively . In morphine 1 mg/kg iv will be given at night. If VAS score 4 injection morphine will be given stat dose (not exceeding three dosed per day).
Clear fluids to be started 6 hours postoperatively can can be converted to solid diet next day and maintenance iv fluids will be given up to 24 hour |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
All patients above 18 years of age attending surgery OPD with carcinoma breast planned for mastectomy with axillary dissection. |
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Past history of surgery on the same breast.
Prior history of radiation.
Patients requiring additional surgical procedures in the same setting.
ASA III & IV
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ERAS protocol when applied in breast surgery especially in MRM will result in early post-operative recovery, less use of opioid analgesics & decreased length of hospital stay.
|
Patient satisfaction on overall pain management during postoperative period using Likert scale at the time of discharge from hospital. Patient will be assessed for pain 6th hr,12th hr , and 24 hrs and then once daily for upto 72 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A.Total amounts of postoperative opioids consumed in terms of total oral morphine equivalents (TME)
B. Patient satisfaction on overall pain management during postoperative period using Likert scale at the time of discharge from hospital.
|
Patient will be assessed for pain 6th hr,12th hr , & 24 hrs & then once daily for upto 72 hrs
|
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
13/02/2024 |
| 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="2"
Months="0"
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
|
Comparison of Enhanced Recovery After Surgery (ERAS) protocol with Conventional Care in patients undergoing Modified Radical Mastectomy for carcinoma breast- a Randomized Controlled Trial-[NIL] In both groups, post-operative pain scores using VAS will be recorded at 6,12 and24 hrs and then once daily from 2nd postoperative day on-wards in both groups for up to 72 hours. Total amount of analgesics and opioids administered will be recorded and converted into Total oral morphine equivalents using www.clinicalc.com software. Presence of post-operative nausea and vomiting will be noted down. If vomiting present antiemetics will be given. Patients’ satisfaction using Likert’s 5 point scale with extremely satisfied to very dissatisfied, will be noted at the time of discharge. Length of Hospital stay will be recorded. Length of the hospital stay will be calculated based on the discharge criteria as mentioned below. Absence of early complications like surgical site infection, flap necrosis and infected drain fluid. Tolerating a normal diet. If drainage less than 50 ml for 2 consecutive days Adequate independent mobilization. Pain adequately controlled by oral analgesics(Vas score less than 4).
Readmission of patients in both groups and the reason for it will be documented. Data collection methods including settings and periodicity
Preoperative data such as age, hemoglobin, albumin, prior chemotherapy, hormonal receptor status etc will be documented. Postoperatively pain recorded based on VAS score at 6, 12, 24 hrs and then once daily from 2nd postoperative day on-wards in both the groups upto 72 hours. Total amount of analgesics , both opioid and non-opioid analgesics consumed will be documented and converted into Total oral morphine equivalents(TME) using clinical software.. Presence of post-operative nausea and vomiting will be noted down( 0- no nausea, 1- presence of nausea and 2 – vomiting present ). Patients’ satisfaction using Likert’s 5 point scale with extremely |