Comparison of Lidocaine Versus Bupivacaine Spinal Anesthesia in Total Hip Arthroplasty: A Randomized, Double-Blind, Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation
研究概览
简要总结
Spinal anesthesia is commonly used in patients undergoing total hip replacements. The purpose of this study is to compare lidocaine to bupivacaine spinal anesthesia in patients having a total hip arthroplasty (THA). The objective of this study is to compare the two spinal anesthesia treatments in regards to transient neurological symptoms (TNS).
详细描述
Most surgeons would agree total hip arthroplasty (THA) is one of the most successful surgical interventions. However, when it comes to the type of anesthesia to improve THA outcomes, surgeons do not agree. General anesthesia has been shown to be associated with increases in adverse events, increased operating room times and increased length of stay. Therefore, more surgeons are turning to spinal anesthesia for better pain control, decreased need for narcotics resulting in less nausea, sooner recovery of bowel function, and faster participation in physical therapy. All of these factors can lead to a sooner discharge from the hospital, which would lead to significant cost savings.
Transient neurological symptoms (TNS) are a concern of using spinal anesthesia and have been shown to occur up to 16-40% of the time with lidocaine. Symptoms of TNS have been described as pain, dysesthesia, or both that occur in the legs or buttocks and urinary retention after recovery from spinal anesthesia. Intensity of pain varies but can be quite severe. Symptoms can appear in a few hours, for up to 24 hours after surgery.
Lidocaine is the most widely used anesthetic due to its rapid onset, intense nerve blockade, and short duration of action. The risk of developing TNS after spinal anesthesia with lidocaine has been shown to be higher when compared to other anesthetics. However, it is unknown whether there are differences between patients who undergo spinal anesthesia with lidocaine versus bupivacaine in THA. This knowledge is important because it has been shown that bupivacaine spinal anesthesia is more effective than lidocaine with minimal adverse effects. A large randomized, prospective study is needed to prove the difference between the two types of anesthesia.
The primary objective of this study is to compare TNS among people who receive one of two spinal anesthesia treatments, lidocaine or bupivacaine. The study will be conducted on individuals who are indicated for THA and have agreed to have spinal anesthesia during their surgery. All patients will be randomized by a computer program and will receive either lidocaine or bupivacaine spinal anesthesia prior to their THA. In addition to TNS, other outcomes include urinary retention, hypotension, ambulation and length of hospital stay.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Radiographic evidence of symptomatic osteoarthritis in one or bilateral hips. Osteoarthritis will be defined as pain with weight-bearing at the hip articulation together with radiographic findings
- •Indicated for total hip arthroplasty
- •Agreement to undergo spinal anesthesia for surgery
排除标准
- •Patient refusal to undergo spinal anesthesia
- •Patients with a known history of lumbar or sacral spinal fusion.
- •Patients with a known history of prostate, urological, or kidney surgery.
- •Patients who need monitoring of urine output during surgery (including patients with confirmed renal disease, renal failure, chronic renal insufficiency, or an indwelling catheter at the time of surgery).
- •Current infection at site of injection
- •Women of child-bearing potential who are on Medicare (child-bearing potential will be determined prior to surgery per Anesthesia standard of care)
- •Hypovolemia
- •Indeterminate neurologic disease
- •Allergy or hypersensitivity to the study medications
- •Currently taking any anti-coagulation medications or coagulopathic
- •Increased intracranial pressure
- •Subject is unable to make his/her own decision regarding the informed consent
- •Subject is unable to read/understand English
研究组 & 干预措施
Lidocaine prior to THA
Participants scheduled for Total Hip Arthroplasty through anterior approach with Lidocaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.
干预措施: Lidocaine (Drug)
Bupivacaine prior to THA
Participants scheduled for Total Hip Arthroplasty through anterior approach with Bupivacaine spinal anesthesia and completing telephone questionnaires to see how they are feeling post-operation.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Number of Participants With Transient Neurological Symptoms (TNS) on Day 1 Post-Operation
时间窗: Day 1 (day of surgery) Post-Operation
Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Post-Operative Transient Neurological Symptoms Score on Day 1 Post-Operation
时间窗: Day 1 (day of surgery) Post-Operation
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 7
时间窗: Post-Operative Day 7
Following a prepared questionnaire, a study team member asked about TNS and pain that was not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Transient Neurological Symptoms Score on Post-Operative Day 7
时间窗: Post-Operative Day 7
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
Number of Participants With Transient Neurological Symptoms on Post-Operative Day 14
时间窗: Post-Operative Day 14
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain not associated with the operation area. The count of participants reporting any type of TNS is presented here.
Transient Neurological Symptoms Score on Post-Operative Day 14
时间窗: Post-Operative Day 14
Following a prepared questionnaire, a study team member asked about symptoms of TNS and pain that was not associated with the operation area. Participants were asked to grade the symptoms on a verbal analogue scale from 0 to 10, with zero as no discomfort and ten as unbearable discomfort.
次要结局
- Number of Participants Discharged 0, 1, or 2 Days Following Surgery(Up to Post-Operative Day 2)
- Number of Participants Voiding Without Complications After Recovery From Spinal Anesthesia(Day 1 (day of surgery) Post-Operation)
- Time to Ambulation After Recovery From Spinal Anesthesia(Day 1 (day of surgery) Post-Operation)
- Count of Participants With Hypotension(Day 1 (day of surgery) Post-Operation)
研究者
Thomas L Bradbury
Associate Professor
Emory University