跳至主要内容
临床试验/CTRI/2025/09/094051
CTRI/2025/09/094051尚未招募不适用

Comparison of quality of recovery, postoperative pain and inflammatory biomarkers amongst opioid free, opioid sparing versus opioid based general anesthesia in breast conservation surgery – A pilot randomized control study.

Self funded1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月29日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
Quality of Recovery QOR 15 score

研究概览

简要总结

Traditional pain management strategies often rely heavily on opiods which can be associated with adverse effects such as sedation, nausea and a risk of dependence. Off late, there is an increasing interest in opiod sparing multimodal analgesic techniques that incorporate regional anesthesia techniques and agents like Lignocaine to improve recovery and pain outcomes.

Traditional pain management strategies often rely heavily on opioids which can be associated with adverse effects such as sedation, nausea and a risk of dependence. Off late, there is an increasing interest in opioid sparing multimodal analgesic techniques that incorporate local anesthetics and agents like intravenous Lignocaine to improve pain outcomes and reduce the risk of developing chronic pain. Understanding the comparative benefits of these agents could guide clinical practice in selecting optimal peri-operative analgesic strategies, more importantly in preventing development of PPSP, CPSP. Opioids form an integral part of general anesthesia. In view of animal studies associating opioids with increased circulating tumor markers and tumor recurrence, more emphasis has been laid upon opioid sparing techniques.Intravenous lignocaine has been integrated as multimodal analgesia, along with regional anesthesia techniques and found to be beneficial in attenuating tumor markers and recurrence. The recovery and pain characteristics of patients vary among patients receiving opioid based general anesthesia with that of opioid sparing and opioid free techniques.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Patients 18 to 75yrs presenting for breast conservation surgery Consenting to be part of study ASA classified Upfront surgery or Prior NACT and RT Associated sentinel LND.

排除标准

  • Non-consenting Associated Axillary dissection Mastectomy Reconstructive breast procedures Other comorbidities like psychiatric illness hepatic renal cardiac dysrhythmia pregnancy chronic pain disorders morbid obesity and allergy to Lignocaine.

结局指标

主要结局

Quality of Recovery QOR 15 score

时间窗: Quality of Recovery QOR 15 score immediate postoperative period till 48 hours

次要结局

  • Pain NRS(Inflammatory Biomarkers PCT CRP)

研究者

发起方
Self funded
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

S Ramkiran

Sri Shankara Cancer hospital and research

研究点 (1)

Loading locations...

相似试验