NCT03838874已完成2 期
Double Blind Randomized Clinical Trial Comparing Time To Return of Lower Extremity Motor Function Following Spinal Anesthetic With Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Time to Return of Lower Extremity Motor Function
研究概览
简要总结
This research is being done to see if there is a difference between two different spinal anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative complications and the time it takes for subjects to regain mobility after surgery.
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)
入排标准
- 年龄范围
- 18 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physiological status I-III (patient must meet criteria of a status I-III in the ASA Physical Status Classification System: I=Normal Healthy Patient, II=Mild Systemic Disease, and III=Severe Systemic Disease)
- •Unilateral primary TKA or THA
- •18+ years of age
- •Able to provide informed consent
排除标准
- •Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome
- •Chronic opioid use (>1 mos) with OME >5 mg/day OR acute opioid use (< 1 mos) with OME > 30 mg/day.
- •Body mass index (BMI) > 45 kg/m2
- •Severe drug allergy* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever)
- •Major systemic medical comorbidities such as:
- •Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) <50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.
- •Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver
- •Contraindication to spinal anesthesia technique (e.g., known spinal stenosis, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame*). *Per ASRA guidelines, Clopidogrel (Plavix) held for at least 7 days, Dabigatran (Pradexa) held for at least 5 days, Rivaroxaban (Xarelto)held for at least 3 days, Warfarin (Coumadin)held for at least 5 days or recent INR of less than 1.4, Enoxaparin (Lovenox) with doses > 1 mg/kg held for close to 24 hours.
- •Known to be currently pregnant or actively breastfeeding. Patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test. Female patients that do not meet this criterion will be asked to submit a urine sample, and will require a negative urine sample in order to proceed with study protocol. Urine sample be collected pre-procedurally.
- •Impaired cognition
研究组 & 干预措施
Low-Dose Bupivacaine
Active Comparator
Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.
干预措施: Low-Dose Bupivacaine (Drug)
Mepivacaine
Active Comparator
Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.
干预措施: Mepivacaine (Drug)
结局指标
主要结局
Time to Return of Lower Extremity Motor Function
时间窗: Post surgery, approximately 1 day
Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.
次要结局
- Post-Anesthesia Care Unit (PACU) Length of Stay(Time of discharge, approximately 1-2 days)
- Discharge Pain Score(Time of discharge, approximately 1-2 days)
- Hospital Length of Stay(Time of discharge, approximately 1-2 days)
- Maximum Pain Score(24 hours following the surgical procedure)
- Median Pain Score(24 hours following the surgical procedure)
- Urinary Retention(Time of discharge, approximately 1-2 days)
- Transient Neurologic Symptoms(One week post-operative)
- Orthostatic Hypotension(Time of discharge, approximately 1-2 days)
研究者
Matthew P. Abdel, M.D.
Principal Investigator
Mayo Clinic
研究点 (1)
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