Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Average Pain Scores for the First 48 Hours
研究概览
简要总结
The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.
详细描述
The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients undergoing total shoulder arthroplasty (not a reverse)
- •Age ≥ 18 years
- •Ability to understand and the willingness to sign an IRB-approved informed consent document.
- •ASA patient status I-III patients
- •Weight Greater than or equal to 50 kg
排除标准
- •Contraindications to an interscalene block or phrenic blockade
- •Infection at injection site
- •Pre-existing neurological dysfunction affecting the operative extremity
- •Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of long-acting opioids
- •Uncontrolled diabetes (A1c >8.0)
- •Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery
- •Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)
- •Patients who are wards of the state
- •History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.
- •Patients with moderate-severe hepatic or renal impairment
研究组 & 干预措施
Liposomal Bupivacaine Interscalene brachial plexus (ISB)
干预措施: Liposomal bupivacaine (Drug)
Bupivacaine with adjuvants ISB
干预措施: Bupivacaine with adjuvants (Drug)
结局指标
主要结局
Average Pain Scores for the First 48 Hours
时间窗: At 48 hours postoperatively
Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.
次要结局
- Postoperative Opioid Consumption for the First 48 Hours(up to 48 hours)
- Satisfaction With Surgical Experience(at 48 hours)