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Clinical Trials/CTRI/2024/08/072663
CTRI/2024/08/072663Not yet recruitingPhase 4

Effect of ultrasound guided Erector spinae plane block and Serratus anterior plane block on inflammatory response in patients undergoing Modified radical mastectomy under general anaesthesia

Maulana Azad Medical College and Associated Lok Nayak Hospital1 site in 1 country50 target enrollmentStarted: August 30, 2024Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
50
Locations
1
Primary Endpoint
1. Serum IL-6 concentration in both the groups

Study Overview

Brief Summary

We are comparing the effect of ultrasound guided Erector spinae plane block and Serratus anterior plane block on inflammatory response in patients undergoing modified radical mastectomy under general anaesthesia. The primary objective of the study is to compare the effect of Serratus Anterior plane block and Erector spinae plane block on serum IL-6 and IL-10 levels in patients undergoing Modified Radical Mastectomy under general anaesthesia, taking a sample size of 50 patients for the study.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 75.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • ASA grade 1, 2, 3 patients.

Exclusion Criteria

  • Bleeding diathesis
  • Local skin infection at the site of block
  • Allergy to local anaesthetics or adjuvants.

Outcomes

Primary Outcomes

1. Serum IL-6 concentration in both the groups

Time Frame: Baseline and 24 hours post-operatively

2. Serum IL-10 concentration in both the groups

Time Frame: Baseline and 24 hours post-operatively

Secondary Outcomes

  • Serum cortisol concentrations in both the groups(Baseline and 24hrs postoperatively)
  • Total consumption of intravenous Fentanyl in both the groups(During the duration of the surgery)
  • Time at which the first rescue analgesia is requested by the patient postoperatively as assessed by the NRS pain score in both the groups(2hrs, 6hrs, 12 hrs and 24hrs postoperatively)
  • Total amount of opioid consumption within 24 hours postoperatively in both the groups(24 hrs postoperatively)

Investigators

Sponsor
Maulana Azad Medical College and Associated Lok Nayak Hospital
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Sandeep J

Maulana Azad Medical College

Study Sites (1)

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