Intercostal Cryoanalgesia in Double Lung Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 3
- 主要终点
- Total opioid use (oral morphine equivalents)
研究概览
简要总结
This study is testing a new way to help manage pain after a double lung transplant. Instead of relying only on strong pain medicines like opioids, doctors will use a cold-therapy probe during surgery to help numb the nerves near the incision. Researchers want to see if this method can reduce the need for opioids and improve recovery.
详细描述
This study is being done to learn whether a special cold-therapy treatment can help control pain after a double lung transplant. During the surgery, doctors may use a device called the Atricure CryoSPHERE MAX Probe, which gently freezes the nerves around the incision to reduce pain for several days. This freezing effect may help patients need fewer opioid pain medicines, which can sometimes cause sleepiness or make it harder to breathe deeply after surgery. Researchers will compare patients who receive the cryotherapy treatment to patients who receive the usual care without the device.
The main goal is to see whether the cryotherapy group uses at least 25% fewer opioids in the first 10 days after surgery. The study will also look at how often patients still need extra pain treatments, such as an epidural, and whether their average daily pain scores are lower. Another important question is whether the treatment can help shorten the amount of time patients need to stay in the ICU. About 148 people from several hospitals will take part in the study. Everyone who joins the study will be followed for one year after their transplant to monitor their recovery and any long-term effects of the treatment.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age
- •Undergoing double lung transplantation via bilateral thoracotomies or clamshell incision
排除标准
- •Multi-organ transplant recipients
- •Redo lung transplant recipients
研究组 & 干预措施
Treatment Arm
Patients will be treated intra-operatively with Atricure CryoSPHERE MAX Probe to 2
干预措施: Atricure CryoSPHERE MAX Probe (Device)
Usual Care
No treatment intra-operatively
结局指标
主要结局
Total opioid use (oral morphine equivalents)
时间窗: 1 year
Total opioid use (oral morphine equivalents)
次要结局
- Frequency of rescue therapy(1 year)
- Median daily pain score(Day 10)
- Duration of ICU Stay(Days 1-10, 30 days, 60 days)
研究者
Abbas Ardehali, MD
Professor of Surgery and Medicine
University of California, Los Angeles
