Effectiveness of iPACK on Postoperative Pain From Hamstring Autograft Following ACL Repair
2021年10月4日 更新者:Brenton Alexander
Effectiveness of Preoperative iPACK on Postoperative Pain From Hamstring Autograft for ACL Repair
Patients undergoing ACL repair with hamstring autograft frequently develop significant post operative pain at the hamstring grafting site.
This pain is within the distribution of a commonly used regional nerve block, the Interspace between the popliteal artery and capsule of the knee (iPACK).
The investigators plan to randomize consenting patients to either receiving a SHAM injection of normal saline or to an interventional group of long acting local anesthetic (Ropivacaine) injected in the popliteal fossa between the popliteal artery and capsule of the knee (iPACK).
Both groups of patients will receive standard of care with respect to perioperative pain management, which includes a preoperative adductor canal nerve block and preoperative acetaminophen administration.
Dual primary endpoints of postoperative pain scores and mean postoperative opioid use will be retrieved and compared between groups.
Additional secondary endpoints will be PACU length of stay, PACU opioid use, POD1 opioids use, and POD1 pain scores (best, worst, average).
研究概览
地位
尚未招聘
研究类型
介入性
注册 (预期的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Brenton Alexander, MD
- 电话号码:(858) 657-7000
- 邮箱:bsalexander@health.ucsd.edu
研究联系人备份
- 姓名:Rodney Gabriel, MD, MAS
- 电话号码:(858) 657-7000
- 邮箱:ragabriel@ucsd.edu
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Undergoing ACL surgery with expected Hamstring Autograft by Dr. Catherine Robertson at UC San Diego
- At least 18 years of age
- Able to Provide Consent in English prior to Surgery
Exclusion Criteria:
- Pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year)
- Inability to communicate with the investigators and hospital staff
- Severe renal, hepatic or cardiac disease
- Chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone)
- BMI > 45 kg/m2
- Allergy to study medications (lidocaine, bupivacaine)
- Incarceration.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Ropivacaine iPACK
Patient will receive standard of care for perioperative pain management.
In addition, they will receive a single preoperative injection of 20cc of 0.25% Ropivacaine with 1:400,000 epinephrine in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK).
|
Injection of 20mL of 0.25% Ropivacaine with 1:400,000 Epinephrine between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles
|
|
假比较器:Normal Saline iPACK
Patient will receive standard of care for perioperative pain management.
In addition, they will receive a single preoperative injection of 20cc of 0.9% Normal Saline in the Interspace between the Popliteal Artery and Capsule of the Knee (iPACK).
|
Injection of 20mL of 0.9% Normal Saline between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Median Post Anesthesia Recovery Unit (PACU) Pain Score
大体时间:From arrival in PACU until patient has been cleared for PACU discharge
|
Median pain score collected in the PACU following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)
|
From arrival in PACU until patient has been cleared for PACU discharge
|
|
Total Perioperative Opioid Use (Morphine equivalents)
大体时间:From time of the start of surgery until time that patient meets PACU discharge criteria
|
Intraoperative and Post Operative (in the PACU) opioid use
|
From time of the start of surgery until time that patient meets PACU discharge criteria
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
PACU Length of Stay (days)
大体时间:From PACU arrival until criteria for PACU discharge are met
|
Length of stay from PACU arrival to "ready for discharge" criteria are met
|
From PACU arrival until criteria for PACU discharge are met
|
|
PACU Opioid Use (Morphine equivalents)
大体时间:From PACU arrival until criteria for PACU discharge are met
|
All opioid use in the PACU
|
From PACU arrival until criteria for PACU discharge are met
|
|
Postoperative Day (POD) 1 Opioid Use (Morphine Equivalents)
大体时间:Time of discharge from PACU until 24 hours after PACU discharge
|
All Opioid use in the approximate 24 hours following PACU Discharge
|
Time of discharge from PACU until 24 hours after PACU discharge
|
|
Best, Worst, Average Pain Scores on POD 1
大体时间:For the entire length of post operative day 1
|
Best, Worst and Average pain scores collected on POD 1 following surgery on a scale of 1-10 (1 being no pain, 10 being the worst pain the patient has ever experienced)
|
For the entire length of post operative day 1
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年12月1日
初级完成 (预期的)
2022年4月1日
研究完成 (预期的)
2022年5月1日
研究注册日期
首次提交
2021年9月7日
首先提交符合 QC 标准的
2021年10月4日
首次发布 (实际的)
2021年10月15日
研究记录更新
最后更新发布 (实际的)
2021年10月15日
上次提交的符合 QC 标准的更新
2021年10月4日
最后验证
2021年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.