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Clinical Trials/CTRI/2025/01/079032
CTRI/2025/01/079032
Not yet recruiting
Not Applicable

Erector spinae plane block for post operative analgesia in modified radical mastectomy. A randomised prospective study.

Dr Gali Nikhila Naidu1 site in 1 country64 target enrollmentStarted: February 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Dr Gali Nikhila Naidu
Enrollment
64
Locations
1
Primary Endpoint
To study the efficacy of Erector spinae plane block for post-operative analgesia in modified radical mastectomy.

Overview

Brief Summary

This is a randomized prospective study evaluating erector spinae plane block for postoperative analgesia in modified radical mastectomy.

Patients are allocated into two groups. Group E patients will receive general anesthesia and erector spinae plane block with a total of 25 ml of 0.25% bupivacaine and dexamethasone 4mg through a 23 G Quincke Babcock spinal needle under ultrasound guidance, while Group C patients will receive only general anesthesia.

The study’s primary objective is to assess the efficacy of Erector spinae plane block for postoperative analgesia using a visual analog pain score. The secondary objective is to assess the Time for the first rescue analgesia and the Total dose requirement of the rescue analgesic.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
25.00 Year(s) to 65.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • ASA I & II patients
  • Patients with Body Mass Index (BMI) between 18.5 and 30 kg per m2
  • Patients who have given consent.

Exclusion Criteria

  • Patients refusal
  • Repeat surgery, pre existing infection at block site
  • Coagulation disorder
  • Preoperative hypotension (mean arterial BP less than 50 mmHg), Bradycardia (hear rate less than 45 BPM), Dysrhythmia, Psychiatric illness.
  • Pre existing neurological deficits.
  • Known allergy to study drugs.
  • Patients belonging to ASA physical status grade III and IV.

Outcomes

Primary Outcomes

To study the efficacy of Erector spinae plane block for post-operative analgesia in modified radical mastectomy.

Time Frame: 12 hours

Secondary Outcomes

  • 1.Time for first rescue analgesia.(2.Total dose requirement of rescue analgesic.)

Investigators

Sponsor
Dr Gali Nikhila Naidu
Sponsor Class
Other [self]
Responsible Party
Principal Investigator
Principal Investigator

Dr Gali Nikhila Naidu

Kidwai Memorial Institute of Oncology

Study Sites (1)

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