Efficacy and Safety of Prilocaine 2% and Lidocaine 5% Hyperbaric Against Spinal Anesthesia in Post Cystoscopy Procedure
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- hs-Troponin serum level
研究概览
简要总结
Regional anesthesia is defined as the temporary removal of nerve conduction and pain in certain areas of the body with local anesthetic drugs without causing loss of consciousness. Spinal anesthesia can provide better analgesia and shorter recovery time in urological procedures resulted in shorter operating times, lower postoperative pain, lower analgesic requirements, and shorter length of stay (LOS) compared to the general anesthesia. Lidocaine is an attractive regional anesthesia drug for ambulatory surgery since it has a rapid onset and rapid recovery from motor and sensory block. However, when it is compared with other local anesthetic agents, the use of lidocaine in spinal anesthesia is associated with an increased risk of transient neurologic symptoms, thus impeding its application to outpatient spinal anesthesia. Lidocaine is more neurotoxic than other local anesthetic agents, especially when high concentrations are applied directly to nervous tissue. Another local anesthetic agent can be used is prilocaine. It has medium potency, rapid duration, and rapid onset of action. Compared with lidocaine, prilocaine has a lower incidence of neurological symptoms in spinal anesthesia for outpatient surgery, and suitable as an alternative to long-acting low-dose local anesthetics. Therefore, the investigators intend to observe the efficacy and safety of these two agents in adult patients who will undergo cystoscopy procedure using spinal anesthesia. In this study the investigators used high-sensitivity C-Reactive Protein (hs-CRP) and high-sensitive Troponin (hs-Troponin). CRP is a systemic inflammation marker associated with conditions such as pain. Troponin can represent patient's kidney function since its metabolism and excretion are affected by changes of estimated glomerular filtration rate (eGFR). Previous study also showed that the use of spinal anesthesia can reduce the incidence of acute kidney injury. Therefore, the investigators aim to carry out further examination of the following two markers regarding to spinal anesthesia using lidocaine and prilocaine.
详细描述
The investigators will conduct a double-blind randomized controlled trial to compare hs-CRP and hs-Troponin levels between prilocaine 2% and hyperbaric lidocaine 5% in adult patients undergoing cystoscopy procedure with spinal anesthesia. This study was approved by the Health Research Ethics Committee (Institutional Review Board) of Dr. Moewardi General Hospital Surakarta. Before randomization, participants who are eligible based on inclusion and exclusion criteria will be given informed consent. If the patients agree, the patient will be included in this research. Ninety adult patients will be randomly divided into control group and treatment group. Control group (group L) will be given 1 mL hyperbaric lidocaine 5% (50 mg) and treatment group (group P) will be given 2.5 mL prilocaine 2% (50 mg) as spinal anesthesia. The investigators will measure hs-CRP serum levels and hs-Troponin serum levels as the primary outcome. Serum levels of hs-CRP dan hs-Troponin will be measured 4 hours postoperative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who will undergo cystoscopy procedure with spinal anesthesia
- •Patients age between 18-60 years
- •Normal BMI according to WHO (World Health Organization) classification (18.5-24.9 kg/m2)
- •Physical status ASA (American Society of Anesthesiologists) I or ASA II according to the ASA Physical Status Classification System by the American Society of Anesthesiologists in
- •Do not have a history of disease, medication, and medical procedures related to coronary heart disease
- •There are no absolute contraindications for spinal anesthesia
- •Do not take non-steroidal analgesics and steroids within 2 weeks before surgery.
- •Do not have history and treatment of Diabetes Mellitus.
- •Willing to participate in research and sign informed consent
排除标准
- •Has been or will be included in other research.
- •Have a direct relative with the research team.
- •Known or suspected to HIV infection.
- •History of hypersensitivity to prilocaine or lidocaine.
- •Patients with impaired renal, hepatic, cardiac rhythm, neurologic function, myopathy, thrombocytopenia (<100,000/mL), and coagulopathy (international normalized ratio >1.5)
研究组 & 干预措施
Group P
Drug: prilocaine 2% Dosage : 50 mg prilocaine 2% (2.5 mL volume)
干预措施: Prilocaine 2% (Drug)
Group L
Drug: hyperbaric lidocaine 5% Dosage : 50 mg hyperbaric lidocaine 5% (1 mL volume)
干预措施: Hyperbaric Lidocaine 5% (Drug)
结局指标
主要结局
hs-Troponin serum level
时间窗: 4 hours postoperative
Serum hs-Troponin at 4 hours postoperative \[ Time Frame: 4 hours postoperative \] hs-Troponin serum concentration will be measured using Enzyme-Linked Fluorescent Assay (ELFA) method as indicator of kidney injury comparing lidocain 5% hyperbaric and prilocaine 2%
hs-CRP serum level
时间窗: 4 hours postoperative
hs-CRP serum concentration will be measured using particle enhanced immunoturbidimetry method as indicator of inflammatory biomarker resulted from pain due to surgery.
次要结局
- Full regression of sensory block(Through Study Completion, an average of 1 day)
- The incidence of adverse effects of hypotension(Through Study Completion, an average of 1 day)
- Pain score after cystoscopy procedure(Through Study Completion, an average of 1 day)
- The incidence of adverse effects of bradycardia(Through Study Completion, an average of 1 day)
- The incidence of adverse effects of nausea.(Through Study Completion, an average of 1 day)
- Duration of PACU (Post-Anaesthesia Care Unit) stay(Through Study Completion, an average of 1 day)
研究者
Septian Adi Permana. MD
Staff Department of Anesthesiology and Intensive Therapy
Universitas Sebelas Maret