A Comparative Evaluation of Opioid Free Anaesthesia Technique Versus the Conventional Technique in Oncological Breast Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative analgesia.
研究概览
简要总结
Background:
Various analgesic modalities are adopted for perioperative analgesia in breast cancer surgeries. Opioid-free and opioid-sparing techniques are gaining popularity due to the lack of opioid-dependent undesirable effects, including respiratory depression, urinary retention, nausea and vomiting, constipation, itching, opioid-induced hyperalgesia, tolerance, addiction, and immune system disorders.
The goal of this prospective randomized clinical trial is to investigate the impact of opioid-free anaesthesia (OFA) versus conventional general anaesthesia (CGA) on postoperative analgesic requirements after breast cancer surgery (lumpectomy/mastectomy, with or without axillary lymph node excision).
Secondary objectives include comparative perioperative evaluation of cognitive function and postoperative adverse events during the first 48 hours atfter surgery. Comparative evaluation of intraoperative haemodynamics and hospital length of stay are also secondary objectives, as well as the incidence of neuropathic pain assessed by validated questionnaires at 3 and 6 months postoperatively.
During the preoperative screening, body measurements, age, gender, ASA (American Society of Anesthesiologists) physical status classification, educational level (using a 6-level scale: elementary, middle school, high school, higher education, higher education, and postgraduate/doctoral degree), home medication, and comorbidities (using the Charlson Comorbidity Index) are recorded.
Intraoperatively, the duration of anaesthesia, duration of surgery, associated intraoperative data (e.g., haemodynamic instability, adverse effects associated with protocol-administered pharmaceutical agents, etc.), and medications administered (type and quantity) are recorded.
The investigators expect to recruit at least 100 participants per group.
详细描述
INTRODUCTION. Opioids are the mainstay for achieving analgesia in the perioperative setting. Standard anaesthetic practice in breast cancer surgery involves balanced general anaesthesia with the use of opioids intra- and postoperatively. Opioid-free anaesthesia (OFA) is a relatively recent anaesthetic proposal whereby no opioid is administered intraoperatively (systemically, in neuraxial or peripheral block or intra-cavity) and the use of opioids is avoided throughout the perioperative period.
Non-opioid anaesthesia appears to provide adequate postoperative analgesia while protecting the patient from the side effects of opioids, which include respiratory depression, opioid-induced hyperalgesia, postoperative nausea/vomiting, cognitive dysfunction, etc. Recently, concerns have arisen regarding delayed healing, immunosuppression, and worsening of oncological outcomes in cancer patients due to the systemic use of opioids.
Side effects of opioids include:
- Respiratory depression
- Muscle stiffness
- Weakness of pharyngeal muscles
- Upper airway obstruction (muscle atony)
- Negative inotropic action
- Nausea, vomiting
- Ileus, constipation
- Urinary retention
- Tolerance and addiction
- Dizziness
- Excessive drowsiness and sleep disorder
BACKGROUND. During the past decade there has been a growing interest in opioid sparing and opioid free techniques for general anaesthesia. The international literature started to be enriched with interesting cases and small prospective studies supporting the benefits of this technique, especially in patients with morbid obesity. According to its proponents, this technique is characterized by: 1) sympatholysis, analgesia, and anaesthesia (MAC reduction) using dexmedetomidine, 2) analgesia with low-dose of ketamine, 3) administration of lidocaine adjunctively for anaesthesia and sympatholysis, 4) deep neuromuscular blockade until the end of the procedure, 5) use of sevoflurane or desflurane 0.7 to 1 MAC in O2/air and titration based on entropy or BIS monitoring and 6) administration of magnesium adjunctively for analgesia. Inadequate sympatholysis is corrected by titrated doses of clonidine, whereas excessive sympatholysis is treated by the administration of vasoconstrictors, preferably ephedrine because of its chronotropic action. In addition, dexamethasone, high-dose paracetamol, NSAIDs, and gabapentin can be used adjunctively in the context of multimodal management of surgical pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •breast cancer surgery (mastectomy, lumpectomy, with or without lymph node excision) under general anaesthesia
排除标准
- •under 18 years
- •patient refusal
- •opioid use (systemic or not) for any reason (e.g., chronic malignant pain)
- •language barrier (difficulty in communicating in Greek language)
- •allergy to the administered agents
- •severe arrhythmia or other serious cardiac disease
- •severe liver and kidney failure
- •dementia, psychiatric diseases, and/or preoperative cognitive impairment
研究组 & 干预措施
Opioid Free Anaesthesia (OFA group)
Patients are randomly allocated to receive non-opioid anaesthesia. Intraoperative analgesia will be achieved by continuous intravenous administration of a mixture of dexmedetomidine, ketamine, and lidocaine.
干预措施: Opioid Free Anaesthesia (OFA) (Other)
Conventional general anaesthesia (CGA group)
Patients are randomly allocated to receive conventional general anaesthesia with intraoperative use of opioids at the discretion of the attending anaesthesiologist.
干预措施: Conventional General Anaesthesia (CGA) (Other)
结局指标
主要结局
Postoperative analgesia.
时间窗: From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.
Postoperative level of analgesia assessed by the NRS (Numerical Rating Scale, ranging from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable).
Postoperative consumption of opioids.
时间窗: From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.
Total postoperative consumption of opioids.
次要结局
- Perioperative consumption of ephedrine.(From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.)
- PACU (Post Anaesthesia Care Unit) length of stay.(From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.)
- Postoperative pruritus.(From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.)
- Postoperative headache.(From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.)
- Postoperative neuropathic pain assessed by the McGill questionnaire.(From hospital discharge until 6 months postoperatively.)
- Postoperative cancer recurrence.(From hospital discharge to 5 years postoperatively.)
- Perioperative blood pressure measurements.(From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.)
- Duration from end of anaesthesia to extubation.(From end of anaesthesia, defined by anaesthetic drug discontinuation, to removal of endotracheal tube, assessed up to 48 hours.)
- Perioperative consumption of atropine.(From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.)
- Perioperative consumption of phenylephrine.(From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.)
- Perioparative pulse measurements.(From the beginning of surgery to PACU (Post Anaesthesia Care Unit) discharge, assessed up to 48 hours.)
- Postoperative paralytic ileus.(From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.)
- Postoperative sedation.(From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.)
- Postoperative neuropathic pain assessed by the S-LANSS pain score.(From hospital discharge until 6 months postoperatively.)
- Postoperative depression and anxiety.(From hospital discharge until 6 months postoperatively.)
- Postoperative episodes of nausea and/or vomiting.(From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.)
- Postoperative respiratory depression.(From PACU (Post Anaesthesia Care Unit) admission to 48 hours postoperatively.)
研究者
Agathi Karakosta
Assistant Professor of Anaesthesiology
University of Ioannina