To compare the efficacy of two types of anesthesia techniques on post operative pain relief in patients undergoing breast cancer study

Completed

• Registration Number: CTRI/2019/08/020865
• Lead Sponsor: Dr BRA IRCH AIIMS New Delhi

Brief Summary

Acute postoperativepain due to ineffective pain control is a major risk factor for the developmentof chronic pain after breast surgery. Opiods has been an integral part of pain management during the perioperative period. But, in recent times, there has been a movetoward opioid‑free anesthesia (OFA) to achieve the goals of hypnosis withamnesia and sympathetic stability without the adverse effects of opioids likerespiratory depression, excessive sedation, pruritus and nausea vomiting.Various methods, such as regional blocks, and drugs, such as lignocaine,dexmedetomidine, ketamine, etc., can be employed to preclude the use of opioids.There is very limited data on the use of opioid free anesthesia in breastsurgery. Hence in this study we plan to compare the analgesic efficacy of opioid free general anesthesia with opioid based general anesthesia in patients undergoing breast cancer surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-09
• Study Completion: 2021-02-28
• Last Update Posted: 2023-06-16

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Age 18-7O years 2.
• ASA I and II 3.
• Patients posted for breast cancer surgery 4.
• Patients giving written informed consent to participate in the study.

Exclusion Criteria

• Patient refusal 3.
• Patients with BMI > 35kg/m2 4.
• Patient with infection at the site of injection 5.
• Coagulopathy 6.
• Spine deformity 7.
• Drug addicts or history of opioid dependence 8.
• Patients with history of allergy to opioids,local anaesthetics or magnesium.
• Patients with myopathy or neuropathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Analgesic efficacy in terms of total postoperative morphine consumption in 24 hours	24 hours

Secondary Outcome Measures

Name	Time	Method
NRS pain score	0,30 min, 1hr. 2hr, 6hr, 24hr post operatively.
Patient satisfaction in a likert scale of 1-7	24 hours post operatively
Neutrophil-Lymphocyte ratio (NLR), Platelet Lymphocyte Ratio (PLR) and number of Natural Killer Cells (NKCs), T helper cells, cytotoxic T cells	1 day prior to surgery, immediate post operative period, 24 hours post operatively
Side effects if any	0, 30 min, 1 hr, 2 hr, 6 hr, 24 hr post operatively

Trial Locations

Locations (1)

Dr BRA IRCH, AIIMS, New Delhi; 🇮🇳 West, DELHI, India

Dr BRA IRCH, AIIMS, New Delhi

🇮🇳West, DELHI, India

Riniki Sarma

Principal investigator

8447456976

riniki_rs@hotmail.com