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临床试验/NCT03948386
NCT03948386已完成4 期

A Randomized, Controlled, Double-Blind Trial of 3 Local Anesthetics for Spinal Anesthesia in Primary Total Hip Arthroplasty to Compare the Percentage of Patients in Each Group With Early Ambulation

Thomas Jefferson University2 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2019年5月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
159
试验地点
2
主要终点
Percentage Ambulating Early After Spinal Anesthesia

研究概览

简要总结

Spinal anesthesia is commonly utilized for hip replacement surgery. Different medications used for spinal anesthesia work for different lengths of time. This study will compare three different spinal anesthesia medications in patients having hip replacement surgery to see if patients are able to get out of bed and walk earlier after surgery with one medication versus the others.

详细描述

Total hip replacement is often performed under spinal anesthesia, which is the standard at Thomas Jefferson University Hospital (TJUH) and Rothman Orthopedic Specialty Hospital (ROSH) for patients without contraindications. Spinal anesthesia involves injecting a numbing medicine (local anesthetic) into the cerebrospinal fluid that bathes the spinal cord through a space between two bones in the back. This causes temporary numbness of the legs and hips and allows surgery to take place without patients feeling pain during surgery. Different local anesthetics can be used for spinal anesthesia and each works for a different duration of time. Another factor that affects how spinal anesthesia medications work is the baricity of the medication, which refers to how dense it is compared to cerebrospinal fluid (CSF). Medications that are less dense than CSF are hypobaric, those with same density are isobaric, and those with greater density are hyperbaric. For clinical purposes, this really only comes into play when positioning the patient immediately after spinal placement as patient position has different effects on the dermatomal level attained depending on baricity of the local anesthetic. Bupivacaine is a long-acting local anesthetic that has been used for several decades for total hip replacement. It is available in both hyperbaric form (with dextrose added) and isobaric form (with no dextrose added). Mepivacaine is another local anesthetic that has a shorter duration of action and is also used for spinal anesthesia in total hip replacement at many centers. All three drugs are used routinely at different centers in the United States. Despite the differences in duration that have been described from pharmacokinetic studies, a randomized, controlled study comparing the three drugs in terms of important outcomes, such as the ability to walk after surgery, has not been published yet. Therefore, the investigators want to compare the three local anesthetics in a randomized, controlled fashion to see if more patients are able to walk sooner after receiving mepivacaine spinal anesthesia than either form of bupivacaine spinal anesthesia.

Patients who are eligible will be called the night prior to surgery and the study will be explained over the phone. Patients who express interest will be recruited on the day of their scheduled surgery in the short-procedure unit. Patients will be given consent forms and time to read them and ask questions.

Preoperative Management All patients without contraindications or allergies will receive oral gabapentin and acetaminophen in the short procedure unit prior to surgery per routine practice.

Intraoperative Management The targeted spinal dermatome level to achieve will be T10 (umbilicus). For isobaric drugs, patients will sit after spinal placement for 3-5 minutes to achieve this level. For hyperbaric bupivacaine, patients will be immediately placed supine and in Trendelenberg position for 3-5 minutes to achieve adequate level and confirmed with sensory pinprick testing, which will be performed every 2 minutes beginning at spinal placement time. After spinal is placed, sedation will be titrated at the discretion of the anesthesia team to achieve the American Society of Anesthesiology's definition of moderate sedation (purposeful response to verbal or tactile stimulation, spontaneous ventilation, and no airway intervention needed) using propofol. All patients will receive tranexamic acid unless contraindicated (10 mg/kg bolus), as well as multimodal analgesia with a non-steroidal anti-inflammatory drug (NSAID) and dexamethasone 4 mg IV per routine practice.

Postoperative Management

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
Double (Participant, Outcomes Assessor)

盲法说明

The anesthesiologist and certified registered nurse anesthetist or resident performing the spinal will be aware of group allocation and will perform spinal anesthesia according to standard operating procedures with the assigned local anesthetic.

Patients will remain blinded and surgeons and those performing postoperative assessments will remain blinded as well.

入排标准

年龄范围
18 Years 至 84 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • undergoing elective primary hip replacement surgery
  • American Society of Anesthesiologists physical status 1-3

排除标准

  • hip fracture
  • contraindication to spinal anesthesia (refusal, coagulopathy or recent use of anticoagulant medication that prevents spinal anesthesia, local or systemic infection)
  • any other reason deemed significant by attending anesthesiologist
  • any patient requiring a wheelchair for ambulation or who cannot walk 25 feet with or without an assist device at time of surgery
  • presence of neuropathy in posterior thighs or buttocks
  • use of greater than the equivalent of morphine 25 mg IV (oxycodone 30 mg PO) daily
  • any patient deemed a poor candidate for spinal anesthesia as determined by the attending anesthesiologist

研究组 & 干预措施

hyperbaric bupivacaine

Active Comparator

hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for > 74" height

干预措施: hyperbaric bupivacaine (Drug)

isobaric bupivacaine

Active Comparator

Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for > 74" height

干预措施: isobaric bupivacaine (Drug)

isobaric mepivacaine

Active Comparator

isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for > 74" height

干预措施: isobaric mepivacaine (Drug)

结局指标

主要结局

Percentage Ambulating Early After Spinal Anesthesia

时间窗: 3.5 hours

Is there a difference between isobaric mepivacaine, hyperbaric bupivacaine, and isobaric bupivacaine when used for spinal anesthesia in primary total hip replacement in percentage of patients that can ambulate within 3.5 hours after spinal anesthesia?

次要结局

  • Number of Patients With Dizziness Events(Postoperative day 2)
  • Return of Motor Function of the Thigh and Lower Leg(Postoperative day 0 (day of surgery))
  • Number of Patients With Transient Neurological Symptoms (TNS)(Postoperative days 0-2)
  • Number of Patients With Urinary Retention Events(postoperative day 1)
  • Hospital Stay(hospital stay (0-3 days))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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