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临床试验/NCT05546021
NCT05546021已完成不适用

Influence of Nociception Level Monitor (NOL) During Guided Analgesic Delivery in Breast Surgeries on the Perioperative Course, Quality of Recovery and Hospital Stay

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Peroperative Morphine consumption

研究概览

简要总结

To assess if perioperative consumption of opioids can be optimized with the assistance of a Nociception Level (NOL) monitor in breast surgery patients receiving pectoral and parasternal nerve blocks as supplementation to general anaesthesia.

Hypothesis:

  1. NOL monitor guidance optimizes perioperative analgesic consumption and postoperative length of stay and offers a better quality of recovery in breast surgery.
  2. Intraoperative NOL monitoring can detect the efficacy of pectoralis and parasternal nerve blocks.
  3. Incidence of persistent neuropathic pain after breast cancer surgery is lower in patients receiving lower doses of perioperative opioids.

详细描述

Optimal perioperative pain management is important not only for patient satisfaction but also for hemodynamic stability and effective restitution. Despite being the principal element of anaesthesia, analgesia delivery has long been based on non-objective surrogate parameters such as blood pressure and heart rate. This may lead to hemodynamic inconsistency, poor restitution and patient dissatisfaction, which are some of the observed challenges. In that context, there has long been a search for a monitor which can guide the meticulous administration of analgesics. Recently, a nociception level monitor (NOL) based on an advanced software algorithm was developed using multiple physiological parameters. It offers an objective number (NOL Index) which relates to the level of intra-operative pain. NOL technology has been validated and found superior to existing pain indicators in peer-reviewed publications. With the availability of NOL monitors, a meticulous adjustment in the administration of opioids became a possibility. Therefore, the investigators are planning a randomised study to investigate if opioid consumption can be reduced and if immediate and long-term postoperative complications can be minimised.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • American Society of Anaesthesiologists (ASA) class I-IV patients scheduled for an elective mastectomy with or without axillary resection

排除标准

  • Inability to give consent,
  • atrial fibrillation,
  • local anesthetic allergy,
  • lumpectomy converted to Mastectomy.

结局指标

主要结局

Peroperative Morphine consumption

时间窗: during the surgery

(peroperative, mg)

Peroperative Remifentanil consumption

时间窗: during the surgery

( peroperative, mg)

次要结局

  • Length of time in recovery room(immediately after surgery)
  • Post-operative opioid consumption(immediately after the surgery)
  • Postoperative Maximum pain score(immediately after the surgery)
  • Requirement for additional antiemetic drugs(immediately after the surgery)
  • Eligible time to discharge(immediately after the surgery)
  • Length of hospital stay(From admission to discharge, up to 72 hours)
  • Incidence of post-operative nausea and vomiting(immediately after the surgery)
  • Persistent neuropathic pain after breast cancer surgery(up to 3 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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