To study long term benefits of Ultrasound guided Erector Spinae Plane block on pain after 3 to 6 months of breast surgery: A Randomized Controllrd Trial

Phase 4

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/10/046523

Lead Sponsor: AIIMS New Delhi

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 130

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
â€¢To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire	â€¢To assess the effect of the ESP block on PMPS at 3 months follow up by using short form McGill pain questionnaire

Secondary Outcome Measures

Name	Time	Method
i.24 hours postoperative consumption of opioids	ii.Intraoperative and postoperative hemodynamic changes

Trial Locations

Locations (1): AIIMS, New Delhi
🇮🇳
South, DELHI, India
AIIMS, New Delhi
🇮🇳South, DELHI, India
Poonam Godhwal
Principal investigator
9968646162
godhwalpoonam@yahoo.in