Addition of a Pectoserratus Block to Interscalene Block in Patients Undergoing Total Shoulder Replacement
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Maximum pain
研究概览
简要总结
The use of ISB in patients undergoing total shoulder arthroplasty (TSA) is the gold standard and results in significantly reduced pain scores and opioid use. However, patients still have pain and the majority require opioids postoperatively as the interscalene block (ISB) doesn't cover all of the dermatomes impacted during TSA. A pectoserratus block typically provides coverage to additional dermatomes that are impacted during TSA. Currently ISB is performed for every patient and perform a pectoserratus block to a portion of our patients undergoing TSA. The purpose of the study is to determine if the addition of the pectoserratus block to the ISB will results in improvement in pain control and decrease in opioid use, among patients undergoing TSA. This is a randomized prospective controlled trial. All patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty aged 18-85 will be considered eligible for the study. Participants will be randomized to one of 2 treatment groups. Group 1 will receive an ultrasound guided pectoserratus block with 25 mL of 0.25% bupivacaine. Group 2 will be the control and receive an ultrasound guided pectoserratus block with 25 mL of saline. The drug will be administered by the anesthesiologist in-charge of the participant's care or an anesthesiologist who is a part of the study team.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be double blinded. The surgeon performing the surgery and the research team member collecting follow-up pain and opioid data will be blinded to the randomization assigned to the patient. The anesthesiologist performing the block and the medical assistant preparing the drugs for the anesthesiologist will be unblinded.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing total shoulder arthroplasty or reverse total shoulder arthroplasty;
- •Patients aged 18-85 years old.
排除标准
- •Patients who have an exclusion to regional anesthesia such as pre-existing nerve damage to their brachial plexus or infection at the site of injection.
- •Patients who have exclusion to interscalene blockade such as severe lung disease.
- •Non-English speakers will be excluded because pain scales are not validated in other languages and there is lack of standardization of pain reporting.
- •Pregnant patients
- •Patients who are currently using opioids and patients with a diagnosis of chronic pain will be excluded.
研究组 & 干预措施
Bupivacaine group
Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the experimental group.
干预措施: bupivacaine. (Drug)
control group
Patients undergoing total shoulder arthroplasty or reverse total shoulderarthroplasty aged 18- 85, randomized to the control group.
干预措施: Saline (Drug)
结局指标
主要结局
Maximum pain
时间窗: 24 hours postop
This measurement is the highest pain score within the first 24 hours post-op. Please change abbreviations for time frames to minutes, hours and years respectively. And the Scale is 0 being no pain to 10 being worst pain.
次要结局
- Opioid use(24 hours postop, 48 hours postop)
- Functional pain score(24 hours postop, 48hours postop)
- hospital length of stay(5 days)