Opioid-free (OFA) versus Opioid-based(OBA) Anaesthesia in Laparoscopic Abdominal Surgeries:A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare postoperative pain scores in both groups by using Numeric Rating Scale(NRS).
研究概览
简要总结
Anaesthesia is built upon four pillars that ensure a safe and effective perioperative experience. The four pillars being hypnosis, autonomic stability ,muscle relaxation and analgesia. Opioids have long been the primary choice for managing perioperative pain due to their strong analgesic effects. However, their use is fraught with significant adverse effects such as respiratory depression ,post-operative nausea ,vomiting, ileus and the risk of dependence or addiction. Apart from this ,the opioid epidemic is a global public health crisis characterized by the widespread misuse of opioid medications ,leading to addiction ,overdose and death. The over-reliance on opioids for pain management , particularly in perioperative care ,has contributed to this crisis, necessitating alternative approaches.
Opioid free anaesthesia (OFA) aims to achieve analgesia without the use of opioids ,instead utilizing a multimodal analgesic regimen with non opioid analgesics, regional anaesthesia techniques,and adjunctive pharmacologic agents .Moreover, OFA has been increasingly integrated into Enhanced recovery after surgery (ERAS) protocols, promoting faster recovery, reduced opioid related complications and improved postoperative outcomes.
Given the ongoing opioid epidemic and the rising awareness of opioid related morbidity and mortality, there is an urgent need to re evaluate perioperative opioid use and explore opioid sparing straregies that maintain effective analgesia while enhancing recovery. This prospective, randomized controlled trial aims to compare the efficacy of OFA versus traditional opioid based anaesthesia(OBA) in patients undergoing laparoscopic abdominal surgeries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult aged 18 years and older undergoing laparoscopic abdominal surgeries.
- •ASA classification I-II .
- •Patients capable of providing informed consent or with consent provided by legal guardian.
排除标准
- •1.Patients with contraindications or allergies to study medications.
- •2.Patients with chronic opioid use or opioid dependence.
- •Pregnant or lactating women.
- •4.Patients refusal.
结局指标
主要结局
To compare postoperative pain scores in both groups by using Numeric Rating Scale(NRS).
时间窗: At immediate postop, 06 hours,12 hours,24 hours postoperatively.
次要结局
- To determine analgesic requirement within first 24 hours.(Time to first analgesic request)