A comparative study of ultrasound guided erector spinae plane block with conventional general anesthesia for postoperative analgesia in modified radical mastectomy: A prospective randomised controlled study
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- To compare the duration of post operative analgesia between two groups.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- Female
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.
Outcomes
Primary Outcomes
To compare the duration of post operative analgesia between two groups.
Time Frame: baseline, after block, after GA, 2min, 5min,10min, 20min, 30min, 60min, 90min, 120min
Secondary Outcomes
- Hemodynamic stability(Post operative requirement of rescue analgesia if VAS more than 4)