Skip to main content
Clinical Trials/CTRI/2024/04/066198
CTRI/2024/04/066198
Not yet recruiting
Not Applicable

Comparative evaluation of ultrasound guided Erector Spinae Plane Block versus Modified Pectoral Nerve Block for post operative analgesia and stress response in patients undergoing Modified Radical Mastectomy

Maulana Azad Medical College and associated Lok Nayak Hospital1 site in 1 country42 target enrollmentStarted: June 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Maulana Azad Medical College and associated Lok Nayak Hospital
Enrollment
42
Locations
1
Primary Endpoint
Time to request for 1st supplemental analgesic requirement post-operatively

Overview

Brief Summary

We are comparing Erector Spinae Plane Block with Modified Pectoral Nerve Block for post operative analgesia and stress response in patients posted for Modified Radical Mastectomy in Lok Nayak Hospital Delhi. A total of 42 patients with 21 patients in each group will be enrolled for the study. Patients will be explained about the study and written informed consent will be taken. A Preoperative blood sample (total of 6ml) will be taken for analyzing serum cortisol, Neutrophil Lymphocyte ratio and Interleukin-6 blood levels. We will be using standard general anesthesia for induction of patients following which USG guided block site will be identified and local anesthetic drug will be administered. Patients will be followed up post operatively for 24 hours during which numerical rating scale for pain, time for first supplemental analgesia and total amount of analgesic consumption will be determined. Another blood sample(total of 6ml) will be taken 6 hours post surgery for analyzing serum cortisol, Neutrophil Lymphocyte ratio and Interleukin-6 blood levels. Overall patient satisfaction score will also be assessed.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • 1.18 to 65 years of age 2.American Society of Anesthesiologists Physical Status I or II.

Exclusion Criteria

  • 1.History of Neuropsychiatric Disorders 2.Infection at local site 3.Coagulopathies and Thrombocytopenia(platelet count less than 1 lacs) 4.BMI more than 30kg/m2 5.On chronic treatment with opioids 6.Pregnancy.

Outcomes

Primary Outcomes

Time to request for 1st supplemental analgesic requirement post-operatively

Time Frame: In postoperative period at 0 minutes,30 minutes,2 hours,4 hours,6 hours,12 hours and 24 hours

Secondary Outcomes

  • 1.Hemodynamic changes(Heart Rate and Mean Arterial Pressure)will be monitored and recorded before induction(baseline),after induction, post block, at skin incision and for every 15 minutes intra-operatively(2.Post-operative NRS score till 24 hours)

Investigators

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

Dr Avnika Laller

Maulana Azad Medical College and associated Lok Nayak Hospital

Study Sites (1)

Loading locations...

Similar Trials