Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Morphine Equivalent Dose of Opioids
研究概览
简要总结
To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement.
详细描述
For the pilot study the investigators will use a total of 20 cases per group.
A HIPAA Waiver will be used for screening purposes. The investigators will be using the electronic medical record system (EPIC) to screen for subjects in the University of Massachusetts Medical (UMass) system.
Subjects will be recruited and consented as described later in the study plan.
Subjects will be randomized to the two groups (standard therapy or BL) using a random number generator. The random number with the type of anesthetic will stored in envelopes and will be opened in sequence on each day of the interscalene nerve block (ISNB).
- Group 1: Standard therapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •Adult subjects older than 18years old undergoing Total Shoulder Replacement (TSR) or reverse TSR surgery.
- •Meet criteria for regional nerve block.
- •Weight greater than 60kg (safety to keep liposomal bupivacaine and bupivacaine dosing below 3mg/kg).
排除标准
- •Recent drug use
- •Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control).
- •Nerve injury (cervical stenosis, trauma, etc) of the surgical limb.
- •Coagulopathy
- •Subjects with significant liver disease (as amide type local anesthetics such as bupivacaine are metabolized by the liver).
- •Infection near or in the area of the nerve block.
- •Subject refusal of regional anesthesia.
- •Vulnerable populations (prisoners, mental impairment / dementia, etc).
- •Subjects requiring interpreter services (not proficient in English).
- •Subjects with poor cardio-pulmonary reserve who might not tolerate a hemi-diaphragmatic paralysis or hemi-diaphragmatic paresis.
研究组 & 干预措施
Bupivacaine Liposome
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist).
- Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%
干预措施: Bupivacaine Liposome Injection (Drug)
Standard therapy
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist).
- Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000.
干预措施: Standard Therapy (Other)
结局指标
主要结局
Morphine Equivalent Dose of Opioids
时间窗: First 24 hours
Morphine equivalent dose (MED) of opioids within the first 24 hours after surgery (including PACU and medications on the floor)
次要结局
- Morphine equivalent dose of opioids(24-48 hours)
- Visual Analogue Scale Pain Score(24-48 hours)
- Hospital Length of Stay(Through study completion, an average of 2-3 days)
- Post-Operative Brief Pain Inventory Short Form(<1 day, 1 day, and 2 days)
- Cost Analysis(Through study completion, an average of 2-3 days)
- Opioid Administration(Up to 72 hours)
研究者
Alexander Chan
Principle-Investigator
University of Massachusetts, Worcester