A comparison between plain general anesthesia and ultrasound guided erector spinae plane block for postoperative pain in breast cancer surgeries

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/08/056238
• Lead Sponsor: Baroda medical college

Brief Summary

Our aim of study is to evaluate efficacy of Ultrasound Guided Erector Spinae Plane Block in Modified Radical Mastectomy , to compare  duration of post operative analgesia between two groups, to monitor hemodynamic changes, to observe requirement of analgesic consumption and complications.

80 adult female patients of Age 18-65 years of ASA II , III  scheduled for Modified Radical Mastectomy will be randomised into 2 groups. Group GE (General anaesthesia + Erector Spinae Plane block) will be receiving 20 ml of 0.5% Levobupivacaine by Ultrasound Guided Erector Spinae Plane Block at T4 unilaterally in sitting position preinduction followed by general anaesthesia. Group G (General anaesthesia) will be induced by conventional general anaesthesia (Fentanyl 2mcg/kg, Propofol 2mg/kg, Vecuronium 0.1mg/kg). Hemodynamics (HR, SBP, DBP, SPO2, EtCO2) will be noted during baseline, after block and at every 20 minutes till the surgery gets completed. Fentanyl Citrate will be supplemented if there will be 20% increase in hemodynamics from baseline. Duration of post operative analgesia in 24hours , VAS score and No. of rescue analgesia will be noted.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 2023-03-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• ASA – II and III Patient posted for elective Modified Radical Mastectomy.
• Patient able to give verbal and informed consent.
• Patient able to understand VAS regarding assessment of pain.

Exclusion Criteria

• Patient refusal Allergy to local anaesthetics.
• Patient with local site infection Pregnant and lactating females Patient who are unable to give consent Patient with coagulopathy disorder Patient with uncontrolled medical conditions like hypertension, diabetes mellitus, renal failure., etc Patient with cardiac, renal, respiratory, neurological conditions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the duration of post operative analgesia between two groups.	baseline, after block, after GA, 2min, 5min,10min, 20min, 30min, 60min, 90min, 120min

Secondary Outcome Measures

Name	Time	Method
Hemodynamic stability	Post operative requirement of rescue analgesia if VAS more than 4

Trial Locations

Locations (1)

SSG hospital Medical college Baroda; 🇮🇳 Vadodara, GUJARAT, India

SSG hospital Medical college Baroda

🇮🇳Vadodara, GUJARAT, India

Dr Kavya S

Principal investigator

9791187041

kavyasurishyam94@gmail.com