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临床试验/NCT04280939
NCT04280939撤回不适用

Spinal Anesthetic for Hip and Knee Replacement Surgery - Intrathecal Morphine or Hydromorphone

Hopital Montfort0 个研究点开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Pain scores

研究概览

简要总结

In the current healthcare system, a short length of stay is paramount, for medical, functional, and financial reasons. Most patients undergoing hip and knee replacement at Hôpital Montfort institution receive spinal anesthetic, with intrathecal morphine for enhanced analgesia. However, morphine can cause urinary retention, nausea or vomiting resulting in increased length of stay (LOS). Based mainly on local experience, The investigators believe hydromorphone may be a good alternative (1). According to the literature review, no adult study compares morphine and hydromorphone.

QUESTIONS Does intrathecal hydromorphone lead to equal or better pain control/post-operative function, with fewer side effects than morphine?

OBJECTIVES. Primary objective: to demonstrate that hydromorphone is the choice narcotic for spinal anesthesia for arthroplasty patients.

Secondary objectives:

  • increased patient satisfaction
  • decreased hospital length of stay METHODOLOGY The investigators propose a prospective randomized double-blind trial with three groups of 155 patients each undergoing total hip arthroplasty (THA), total knee arthroplasty (TKA), or unicompartmental knee arthroplasty (UKA), striving for similar proportions of each procedure in all three groups.
  • Group 1: spinal anesthetic with standard painkillers, without intrathecal narcotics (ie "placebo" group)
  • Group 2: spinal anesthetic with intrathecal morphine
  • Group 3: spinal anesthetic with intrathecal hydromorphone The primary outcome measure will be urinary retention. Secondary outcome measures will be nausea/vomiting, pain control, post-operative function and length of stay.

RESULTS The investigators expect to show that intrathecal hydromorphone will provide the best combination of post-operative patient pain control and function, with diminished negative side effects. They hope to extrapolate this to a potential out-patient arthroplasty program.

详细描述

A significant increase in the number of patients receiving hip or knee replacements can be expected in the coming years, for two main reasons: an increase in the number of elderly patients in the society and the fact that joint replacements are offered to younger patients because of an improvement in materials, designs, and survivorship of prostheses in general. As a result, healthcare institutions are facing pressure to provide more services, while decreasing overall spending.

Hôpital Montfort is an important component of the healthcare structure in Ottawa and Eastern Ontario, providing hip or knee replacements to roughly 1200 patients every year. These include total hip and knee replacements, partial medial and lateral knee replacements, and patellafemoral replacements. Some partial knee replacement surgeries are bilateral, meaning both knees are operated at the same sitting.An increase in the demand for joint replacements is expected. This will follow the national trend of the last 5 years (2012-2017): 17.8% increase in hip replacements and 15.5% increase in knee replacements. This in turn will continue to place an unbearable financial burden on the healthcare system, as implanted components are very expensive. Furthermore, patients undergoing joint replacement also often require the use of ancillary services such as physiotherapy, occupational therapy, and inpatient rehabilitation. However, the healthcare system is under tremendous strain, as budgets can no longer allow previous levels of spending. It is this current economic context that is forcing healthcare professionals to find ways to decrease costs as much as possible, while maintaining productivity.

Over 95% of joint replacements at Hôpital Montfort are performed under spinal anesthetic. Intrathecal morphine is added to standard anesthetic medication for better immediate post-operative pain control, which in turn facilitates rapid patient mobilization. However, most orthopedic surgeons would prefer to avoid morphine, because of a recognized higher incidence of post-operative side-effects, mainly urinary retention, nausea, and vomiting. It is very difficult to send patients home when they cannot urinate, tolerate oral intake, or mobilize safely. Patients who experience one of these post-operative complications stay in hospital. Discharging these patients home can be unsafe, but also leads to patient dissatisfaction, and the perception of uncaring and unsympathetic care. Many patients do not understand the financial implications of a prolonged stay in hospital, and expect that they can stay as long as they want.

A medication that can meet all our patients' needs: effective analgesia, early mobilization, and minimal negative side effects, is still to be found, so patients can go home sooner, The anesthesia literature seems to indicate that hydromorphone might be the right choice, but no study compared intrathecal morphine and hydromorphone usage in the adult population.

QUESTIONS

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • all patients having a hip or knee replacement at Hôpital Montfort,
  • candidates for spinal anaesthetic,
  • and who give their consent

排除标准

  • allergy to morphine or hydromorphone;
  • spinal anesthetic is contra-indicated;
  • patients who cannot or refuse to give consent;
  • all emergency cases.

结局指标

主要结局

Pain scores

时间窗: one day after surgery

visual analog pain scale (ranges from 0=no pain to 10= worst pain ever), use of analgesics (yes/no, count)

Nausea and vomiting

时间窗: immediately after surgery

use of anti-emetics - episodes of nausea and vomiting will be reported by nurses, use of anti-emetics will be recorded (yes/no, count)

Urinary retention

时间窗: immediately after surgery

measured with bladder scan, number of catheterizations required (yes/no)

Specific patient-reported outcomes for arthroplasty

时间窗: one month after surgery

Oxford Knee/Hip Score (ranges from 0=worst outcome to 48= better outcome)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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