Intercostal Nerve Cryoablation for Postoperative Pain Management
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- 5-point Satisfaction Scale
研究概览
简要总结
The purpose of the study is to assess the efficacy of intercostal nerve cryoablation on the magnitude and duration of postoperative pain control both in patients undergoing thoracoabdominal incisions for the descending or thoracoabdominal aortic aneurysm repair.
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
- Single (Participant)
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
- •Descending/thoracoabdominal incision is planned
- •There is reasonable expectation that the patient will be extubated within 48 hours after surgery
排除标准
- •The patient has a known allergy to morphine or any opioid
- •The patient has a known chronic pain disorder or takes daily opioid medication > 1 month prior to surgery
- •The surgeon/anesthesiologist concludes that the period for intubation will be likely be for more than 48 hours after surgery There is anticipated difficulty communicating pain status due to language or other barriers at the investigator discretion.
研究组 & 干预措施
Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
干预措施: Intercostal Nerve Cryoablation (Device)
Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
干预措施: Bupivacaine liposomal injectable suspension (Drug)
Intercostal Nerve Cryoablation plus SOC Pain Control
Standard of Care (SOC)
干预措施: Patient-controlled analgesia (PCA) (Drug)
Standard of Care (SOC) Pain Control
干预措施: Bupivacaine liposomal injectable suspension (Drug)
Standard of Care (SOC) Pain Control
干预措施: Patient-controlled analgesia (PCA) (Drug)
结局指标
主要结局
5-point Satisfaction Scale
时间窗: post-operative day 180
The 5-point satisfaction scale assesses post-surgical analgesia satisfaction. The total score ranges from 1 to 5, with 1 being "very dissatisfied" and 5 being "very satisfied".
Score on Numeric Pain Scale (NPS)
时间窗: post-operative day 5
The NPS measures the intensity of pain. The total score ranges from 0 to 10, with 0 being no pain and 10 the highest pain.
Brief Pain Inventory (BPI) - Severity Score
时间窗: post-operative day 180
The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The total severity score ranges from 0 to 10, with 0 indicating no pain and 10 indicating pain as bad as you can imagine.
Brief Pain Inventory (BPI) - Pain Interference Score
时间窗: post-operative day 180
The Brief Pain Inventory is a medical questionnaire used to measure pain, developed by the Pain Research Group of the WHO Collaborating Centre for Symptom Evaluation in Cancer Care. The pain interference score indicates how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The total pain interference score ranges from 0 to 10, with 0 indicating no interference and 10 indicating complete interference.
次要结局
- Total Amount in mg of Opioid Medication Consumed(third to fifth post-operative days after surgery)
- Number of Participants Who Require of Opioids at the Time of Discharge(at the time of discharge (about a week after surgery))
- Number of Participants Who Utilize Patient-controlled Analgesia (PCA)(from the time immediately after surgery to post-operative day 3)
- Amount of Patient-controlled Analgesia (PCA) Used(from the time immediately after surgery to post-operative day 3)
- Number of Participants Who Attain Physical Therapy Goal That Justifies Discharge From Inpatient Physical Therapy Within 72 Hours(72 hours after surgery)
- Length of Hospital Stay(at the time of discharge (about a week after surgery))
- Hospital Cost for Patient Care During Hospitalization(at the time of discharge (about a week after surgery))
研究者
Anthony L Estrera
Professor
The University of Texas Health Science Center, Houston