A Prospective, Double-blinded, Randomised Controlled Trial Comparing the Use of Hyperbaric Bupivacaine Versus Hyperbaric Prilocaine for Spinal Anaesthesia in Asian Patients Undergoing Elective Total Knee Replacement
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Duration of Motor Block
研究概览
简要总结
Prilocaine numbs you for a shorter time, allowing you to regain movement quicker, which helps you recover faster, start rehab sooner, and feel more satisfied with your treatment overall.
详细描述
Bupivacaine has long been the go-to choice for spinal anesthesia in total knee replacement surgeries due to its effectiveness in providing surgical anesthesia. However, it comes with some drawbacks, primarily its prolonged motor block and the potential for dose-related hypotension, which can hinder post-operative recovery. In contrast, prilocaine has gained popularity in recent years, particularly for outpatient procedures and even caesarean sections. Prilocaine's appeal lies in its faster recovery profile, characterized by a shorter duration of motor block and reduced incidence of urinary retention. These properties make it an attractive option for total knee replacement patients, as it potentially allows for quicker rehabilitation. The shorter-acting nature of prilocaine means patients may regain mobility sooner, potentially leading to earlier discharge and improved overall satisfaction. Despite these promising attributes, there's a notable gap in research comparing the intrathecal use of hyperbaric prilocaine 2% with hyperbaric bupivacaine 0.5%, especially within the Asian population. This lack of comparative studies highlights the need for further investigation to determine if prilocaine's benefits observed in other contexts translate effectively to total knee replacement procedures in Asian patients, potentially offering a pathway to enhanced recovery protocols in this specific demographic.
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
- Double (Participant, Outcomes Assessor)
盲法说明
This helps to eliminate potential placebo effects or bias in self-reported outcomes. The masking of outcome assessors ensures that the individuals evaluating the results of the trial are unaware of which treatment each participant received. By masking both participants and outcome assessors, the study aims to minimize bias and increase the reliability of the results, as neither the subjects nor those evaluating their progress can be influenced by knowledge of the treatment assignment."
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing elective unilateral total knee replacement
- •Able to give informed consent
排除标准
- •Patients of age < 21 or > 90 years old
- •American Society of Anaesthesiologists (ASA) physical status> III
- •Extremes of weight: <40kg or BMI >40
- •Contra-indications to spinal anaesthesia, prilocaine or bupivacaine (including allergy to local anaesthesia agents or patients at high risk for methaemoglobinemia)
- •Complex TKR as deemed by surgeons
- •Patient refusal
- •Failure of spinal anaesthesia resulting in conversion to general anaesthesia, prior to start of operation
- •Patients with prostate hyperplasia or urogenital pathologies
- •Planning to conceive / pregnant women / breastfeeding
研究组 & 干预措施
bupivacaine
The administration of the spinal anesthetic will follow the hospital's standard protocol for this procedure. This means that apart from the specific local anesthetic used (prilocaine or bupivacaine), all other aspects of the anesthesia process - including patient preparation, sterile technique, needle size and type, patient positioning, and post-procedure care - will remain consistent with the hospital's established guidelines for spinal anesthesia
干预措施: prilocaine (Drug)
prilocaine
The administration of the spinal anesthetic will follow the hospital's standard protocol for this procedure. This means that apart from the specific local anesthetic used (prilocaine or bupivacaine), all other aspects of the anesthesia process - including patient preparation, sterile technique, needle size and type, patient positioning, and post-procedure care - will remain consistent with the hospital's established guidelines for spinal anesthesia
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Duration of Motor Block
时间窗: Measured from the time of spinal anesthesia administration until full motor recovery, expected within 24 hours post-operation.
This study will measure the duration of motor block, defined as the time from spinal anesthesia administration to full recovery of motor function. Motor function will be assessed using the modified Bromage scale, with full recovery defined as a Bromage score of 0 (full movement of legs and feet). The primary hypothesis is that prilocaine will produce an effective sensory block while resulting in a significantly shorter duration of motor block compared to bupivacaine. Assessments will be conducted at regular intervals following the administration of spinal anesthesia until full motor recovery is achieved, with an expected timeframe of up to 24 hours post-operation. This outcome measure will help determine the comparative efficacy of prilocaine versus bupivacaine in facilitating earlier mobilization and potentially enhancing post-operative recovery in patients undergoing total knee replacement surgery.
次要结局
- Comparison of Side Effects between Prilocaine and Bupivacaine(From spinal anesthesia administration up to 24 hours post-operation.)