Intraosseous Morphine Administration During Anterior Cruciate Ligament Reconstruction: a Randomized Control Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.
研究概览
简要总结
The purpose of this study is to determine if intraosseous (IO) morphine decreases pain and post-operative opioid use in patients undergoing anterior cruciate ligament (ACL) reconstruction.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of the IRB approved surgeon(s) undergoing ACL reconstruction with bone-to-bone (BTB) autograft
- •Patients aged between 18-40 years old at the time of surgery
排除标准
- •Patients undergoing ACL reconstruction with any other type of autograft or allograft other than BTB
- •Patients younger than 18 years old or older than 40 years old
- •Patients undergoing meniscal root repair or any other repair that changes their weight-bearing status
- •Patients with a history of substance abuse
- •Vulnerable populations
- •Patients on chronic pain medication within the last 6 months
- •BMI >/= 35
- •Allergy to morphine
- •Unwilling to participate
- •Any additional reason the PI deems reasonable
研究组 & 干预措施
Intraosseous Injection of Morphine
The intervention group will receive an intraosseous (IO) injection of 10mg of morphine mixed with up to 100mg of saline into the tibial tubercle during a standard ACL reconstruction.
干预措施: Intraosseous Morphine (Drug)
结局指标
主要结局
Patient Pain Levels in the Post-Operative Period as assessed by a patient-reported post operative symptom journal.
时间窗: 2 weeks postop, 6 weeks postop, 12 weeks postop
The study will measure patient-reported levels of pain on a daily basis (for a total of two weeks) with a symptom journal, which will ask patients to report on a variety of pain-related outcomes including levels of pain throughout different times of day, levels of nausea throughout different times of the day, and what pain medication(s) they are taking and at what time.
Changes in Post-Operative Opioid Use
时间窗: 2 weeks postop
To examine if the use of IO morphine will result in different levels of post-operative opioid use compared to SOC administration of morphine. This outcome will be assessed utilizing the daily symptom journal which will ask patients to complete daily logs of the pain medication that they take (what kind, what dose, when they took it, etc.) for two weeks following their operation.
Patient Pain Levels in the Post-Operative Period as assessed by the Lysholm Knee Survey
时间窗: 2 weeks postop, 6 weeks postop, 12 weeks postop
Participants will be asked to complete the Lysholm Knee survey at 2, 6, and 12 weeks postop which will assess patient progress following surgery such as pain, swelling, climbing stairs, using a crutch, etc. The Lysholm scale consists of eight items with each question response being assigned an arbitrary score on an increasing scale. The total score is the sum of each response to the eight questions and may range from 0-100 where higher scores indicate a better outcome with fewer symptoms or disability.
次要结局
- Patient Range of Motion in the Post-Operative Period as assessed by the KOOS, JR Knee Survey(Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop)
- Patient Activity Level in the Post-Operative Period as assessed by the Tegner scale.(Preop, 2 weeks postop, 6 weeks postop, 12 weeks postop)
- Patient Range of Motion in the Post-Operative Period as assessed by the Lysholm Knee Survey(2 weeks postop, 6 weeks postop, 12 weeks postop)
研究者
Robert A. Jack
Assistant Professor of Clinical Orthopedic Surgery, Academic Institute
The Methodist Hospital Research Institute