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Clinical Trials/CTRI/2022/10/046523
CTRI/2022/10/046523Not yet recruitingPhase 4

To study the long term benefits of Ultrasound guided Erector Spinae Plane block on Post Mastectomy Pain Syndrome in patients undergoing breast surgery: A Randomized Controlled Trial

AIIMS New Delhi1 site in 1 country130 target enrollmentStarted: October 20, 2022Last updated:

Trial Snapshot

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Enrollment
130
Locations
1
Primary Endpoint
•To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire

Study Overview

Brief Summary

The peri-operative pain management appeared as major point to reduce the risk of chronic pain after surgery. A potential target for an interventional procedure for chronic pain after treatment for breast cancer is the Erector Spinae Plane (ESP) block. Here, local anaesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerve dermatomes from vertebral C5 to T6. Local anaesthetic expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally. This block can be given unilaterally for breast surgeries with anaesthesia similar to that of thoracic epidural block without its hemodynamic side effects.  In this study we will compare ESP block with control for prevention of post mastectomy pain syndrome.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Open Label

Eligibility Criteria

Ages
20.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age 20-65 years American Society of Anesthesiologists (ASA) physical status I-II Scheduled for elective surgery for breast cancer (unilateral surgical procedure).

Exclusion Criteria

  • 1.Patient refusal 2.Infection of the skin at the site of the needle puncture 3.Chronic infection 4.Known allergies to any of the study drugs 5.Coagulopathy 6.Patient already receiving analgesics 7.Mentally challenged patients 8.Liver and renal dysfunction.

Outcomes

Primary Outcomes

•To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire

Time Frame: •To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire

Secondary Outcomes

  • i.24 hours postoperative consumption of opioids(ii.Intraoperative and postoperative hemodynamic changes)

Investigators

Sponsor
AIIMS New Delhi
Sponsor Class
Research institution and hospital

Study Sites (1)

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