Bupivacaine Liposome Plus Bupivacaine or Ropivacaine for PENG Block on Post Operative Pain Management in Patients Undergoing Hip Arthroplasty: a Prospective, Randomized, Single Blind, Active Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Overall Opioid Consumption
研究概览
简要总结
The goal of this clinical trial is to study the analgesic effect of liposomal bupivacaine plus bupivacaine for Pericapsular Nerve Group (PENG) block in postoperative pain management following hip replacement surgery. It will also assess the safety of liposomal bupivacaine for this purpose. The main questions it aims to answer are:
- Is liposomal bupivacaine plus bupivacaine superior to ropivacaine in terms of analgesic efficacy, duration of pain relief, opioid consumption, and patient satisfaction?
- What medical problems do participants encounter when using liposomal bupivacaine plus bupivacaine for PENG block in postoperative pain management following hip replacement surgery?
Researchers will compare liposomal bupivacaine plus bupivacaine to ropivacaine (a routinely used regional anesthetic in clinical practice) to determine if liposomal bupivacaine plus bupivacaine is more effective for pain management following hip replacement surgery.
Participants will:
- Receive liposomal bupivacaine plus bupivacaine or ropivacaine as a regional anesthetic for PENG block under ultrasound guidance.
- Undergo hip replacement surgery under spinal anesthesia.
- Have pain relief, opioid analgesic consumption, and incidence of complications assessed at multiple time points within 72 hours after surgery.
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, Outcomes Assessor)
盲法说明
Given the distinct visual appearance of the liposomal bupivacaine (milky white) and ropivacaine (transparent), a double-blind study design is not feasible.
Consequently, this study employs a single-blind approach where neither participants nor outcome assessors will be aware of treatment allocation. Healthcare providers administering the study drug will be aware of the treatment group assignment. Rigorous procedures will be implemented to minimize potential bias, including standardized outcome assessment tools, blinded data entry, and independent data analysis.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists(ASA) I~II
- •Normal coagulation
- •Clinical diagnosis of hip fracture
排除标准
- •Presence of severe systemic diseases or ASA grade III or higher
- •Allergy to amide local anesthetics
研究组 & 干预措施
Liposomal Bupivacaine plus Bupivacaine Intervention
Participants in this arm will receive liposomal bupivacaine(LB) plus bupivacaine(B) as a local anesthetic for PENG block under ultrasound guidance. Liposomal bupivacaine plus bupivacaine is being investigated for its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of liposomal bupivacaine plus bupivacaine compared to the standard local anesthetic, ropivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery.
干预措施: Liposomal bupivacaine plus bupivacaine (Drug)
Ropivacaine Intervention
Participants in this arm will receive ropivacaine (R) as a local anesthetic for the PENG block under ultrasound guidance. Ropivacaine, a routinely used local anesthetic in clinical practice, is being compared to liposomal bupivacaine plus bupivacaine to assess its analgesic effect in postoperative pain management following hip replacement surgery. This arm aims to evaluate the analgesic efficacy, duration of pain relief, and safety profile of ropivacaine in comparison to the investigational intervention, liposomal bupivacaine. Participants in this arm will undergo hip replacement surgery under spinal anesthesia and will be assessed for pain relief, opioid analgesic consumption, and any associated complications at multiple time points within 72 hours after surgery.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Overall Opioid Consumption
时间窗: this outcome will be monitored and recorded within 72 hours postoperatively
This primary outcome entails tracking and assessing the total opioid consumption by participants following hip replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain.
次要结局
- Time to First Rescue Analgesic(72 hours after surgery.)
- Incidence of Complications or Adverse Events(90 days after the surgical procedure)
- Pain intensity(at multiple time points within 72 hours post-surgery.)
- Duration of Hospital Stay(through study completion, an average of 1 year)
研究者
Wei Mei
Clinical Professor
Huazhong University of Science and Technology