Comparison of analgesic efficacy of two regional anaesthetic techniques in breast cancer surgery patients.

Not yet recruiting

• Conditions: Patients with clinical diagnosis of breast carcinoma posted for modified radical mastectomy

• Registration Number: CTRI/2018/07/014913
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Breast cancer is the most common cancer found in women worldwide.Perioperative pain management is one of the crucial elements required for optimal outcome of patients undergoing breast cancer surgery.Various techniques like the wound infiltration, intravenous opioids, thoracic epidural and thoracic paravertebral have been used for postoperative pain management in these patients.Recently, fascial plane blocks are being increasingly employed for intraoperative and postoperative pain management in these patients.These fascial plane blocks include Modified Pectoralis nerve block, Serratus anterior plane block and Erector spinae plane block.Among all regional anaesthetic techniques, which is the most efficacious, safe, technically simple and less time consuming is questionable.No randomized clinical trial has been done to compare the analgesic efficacy of ESPB and SAP block.Hence we planned a prospective randomized clinical trial to compare the analgesic efficacy of SAP block and ESPB in patients undergoing modified radical mastectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 1.Female patients with carcinoma breast 2.
• Age group -18-70 years 3.
• ASA Physical status 1,2,3 scheduled to undergo modified radical mastectomy.

Exclusion Criteria

1.Patients Refusal 2.Patients with infection at the site of SAP or ESPB block 3.Patients with severe chest wall deformity 4.Patients with history suggestive of coagulopathy or receiving any anticoagulants 5.Presence of complications like mental illness, severe heart disease (NYHA classification ≥3) 6.Any renal or hepatic disorder before surgery 7.Allergic to any drug being used during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate and compare the time to first dose of rescue analgesic in the post-operative period in patients undergoing modified radical mastectomy under combined general anaesthesia and serratus anterior plane block with patients undergoing modified radical mastectomy under combined general anaesthesia and erector spinae plane block.	To evaluate and compare the time to first dose of rescue analgesic at the time when numerical rating score more than 4 in the post-operative period in patients undergoing modified radical mastectomy under combined general anaesthesia and serratus anterior plane block with patients undergoing modified radical mastectomy under combined general anaesthesia and erector spinae plane block.

Secondary Outcome Measures

Name	Time	Method
a.To evaluate and compare the total dose of rescue analgesic needed intraoperatively.	b. To evaluate and compare the total dose of rescue analgesics required postoperatively.

Trial Locations

Locations (1)

AIIMS,New Delhi; 🇮🇳 West, DELHI, India

AIIMS,New Delhi

🇮🇳West, DELHI, India

Dr Deepti Ahuja

Principal investigator

9643623425

deeptiahuja2252@gmail.com