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临床试验/NCT01785940
NCT01785940已完成不适用

Evaluation of Ultrasound Guided Continuous Interscalene Block for Same Day Discharge Following Total Shoulder Arthroplasty - An Open Label Feasibility Study

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Pain scores: Visual analog scores

研究概览

简要总结

Total shoulder surgeries are associated with considerable postoperative pain which may prevent rehabilitation and early discharge from the hospital. Continuous interscalene blocks with home infusions are commonly performed for pain relief following total shoulder arthroplasties. We want to evaluate the time to readiness for discharge following interscalene blocks in patients undergoing total shoulder arthroplasties.

详细描述

The number of shoulder replacement surgeries is increasing over the years and it is expected to continue as the population ages (1). This necessitates adequate pain control in the immediate and early postoperative period when pain levels are typically high. Adequate analgesia ensures patient comfort and the ability to perform physical therapy exercises associated with positive surgical outcomes (2-3). Interscalene brachial plexus block (ISB) is commonly performed to provide analgesia for patients undergoing surgical procedures in the shoulder region. Either single injection blocks or continuous perineural infusions are performed along with oral medications for better pain control in these patients. Compared with intravenous opioids, ISB is known to produce superior analgesia after major shoulder surgery (4,5). There are reports of outpatient TSA discharged directly from the recovery room following the use of continuous ISB but achievement of adequate range of motion were not tested in them (6). Consequently, ambulatory ISB may offer decreased hospitalization while ensuring adequate analgesia after TSA. Ilfeld et al (7) prospectively compared ISB and opioids regarding the time to readiness for discharge following TSA, which was followed by many other studies demonstrating the safety and efficacy of continuous ISB for TSA (8, 9). Ilfeld et al (6) showed that discharge criteria were 21 (16-41) h with the use of ISB as compared to 51 (37-90) h for those receiving perineural normal saline. In our centre, healthy patients requiring shoulder arthroplasty usually remain as in-patients for management of pain. Perineural infusions may be continued at home using a portable infusion pump after discharge. With the use of disposable portable infusion pump for continuous ISB, it may be feasible to discharge patients and reduce hospitalization time.

Although the study by Ilfeld et al showed continuous ISB allowing earlier home discharge following TSA, the patients in the study were evaluated for readiness to discharge on POD1 at 10 AM rather than the earliest times possible. Another interesting finding is that all patients received ropivacaine infusions till 6 AM of POD1 but the authors also claim to have discharged few patients on the same afternoon after the surgery. The block infusions reported in previous studies are higher than used at our institute.

There is also conflicting evidence that although continuous ISB provides adequate analgesia, they seldom impact early functional rehabilitation (10). With this background we want to evaluate the earliest times for the achievement of readiness to discharge with the use of ISB following TSA.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and females of 18-80 years of age, scheduled to undergo elective shoulder arthroplasty.
  • ASA Class I, II, III

排除标准

  • Patients with associated significant cardiac and respiratory disease.
  • Patients who will need hospitalization due to reason other than the planned surgery.
  • Patients with coexisting sleep apnea or morbid obesity (BMI> 35).
  • Patients with pre-existing major organ dysfunction such as hepatic and renal failure.
  • Psychiatric illnesses.
  • Lack of informed consent.
  • Allergy to any of the drugs used in the study.
  • Contraindications to interscalene block

结局指标

主要结局

Pain scores: Visual analog scores

时间窗: first 24 postoperative hours

The patients will be evaluated for home discharge based on the degree of analgesia (VAS scores of \< 40/100 on movement) at arrival to PACU, and at every 2 hours for the first 6 hours postoperatively and every 4 hourly till 6 AM on the morning of POD1 and at 23 postoperative hours.

次要结局

  • Range of motion(First 24 postoperative hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shalini Dhir

Principal Investigator

Lawson Health Research Institute

研究点 (2)

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