Comparison of Enhanced Recovery After Surgery (ERAS) protocol with conventional care in patient’s understanding Modified Radical Mastectomy for Carcinoma breast

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2024/02/062325
• Lead Sponsor: Jawaharlal Institute of Postgraduate Medical Education and Research JIPMER

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.](http://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.

1. Absence of early complications like surgical site infection, flap necrosis and infected drain fluid.

2. Tolerating a normal diet.

3. If drainage less than 50 ml for 2 consecutive days

4. Adequate independent mobilization.

5. 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.

1. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-13
• Last Update Posted: 2024-03-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

All patients above 18 years of age attending surgery OPD with carcinoma breast planned for mastectomy with axillary dissection.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

jipmer; 🇮🇳 Pondicherry, PONDICHERRY, India

jipmer

🇮🇳Pondicherry, PONDICHERRY, India

DR SHIVANAND

Principal investigator

9591565080

shosamani87@gmail.com