Intravenous Lidocaine and Time to Regression of the Sensory Block After Spinal Anesthesia With Isobaric Bupivacaine in Patients Undergoing Surgery to Treat Skin and Soft Tissue Tumors of the Lower Limbs
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Time to T12 regression of the sensory block
研究概览
简要总结
The use of intravenous lidocaine in continuous infusion in the perioperative period is associated with a reduction in postoperative pain scores, opioid use, incidence of nausea and vomiting, among other favorable outcomes. However, this therapeutic intervention has not yet been adequately evaluated by clinical trials when associated with regional anesthesia. The aim of this study is to evaluate whether the use of intravenous lidocaine in continuous infusion during spinal anesthesia with isobaric bupivacaine alters the time to regression of sensory block in patients undergoing surgical procedures for the treatment of bone and connective tissue tumor surgeries. This will be a triple-blind randomized trial. The sample size estimated was 66 patients. The study will include all patients who meet the pre-established inclusion and exclusion criteria, choose to participate, and agree with the Informed Consent Form. The main anesthetic technique will be spinal anesthesia with 13 mg of isobaric bupivacaine. Patients will be allocated in two groups in a blindly after randomization: Group S (lidocaine 0.75mg.kg-1 in bolus followed by infusion of saline solution) and Group L (lidocaine 1.5 mg.kg-1 followed by continuous infusion of lidocaine solution at 2 mg.kg-1.h-1). The primary outcome will be the time to T12 regression of the sensory block. Will also be evaluated: time to regression of the motor block, most rostral dermatome achieved by the sensory block, time to two-segment regression oh the sensory block, propofol dose in the operating room, postoperative pain score at rest, pain at movement score, quality of recovery, use of opioids in the postoperative period, nausea or vomiting, dizziness, shivering, arrhythmias, hypotension, urinary retention, and length of stay. The records will be assigned to the RedCap database. The data will be extracted without identification of the allocation groups for the R software and the groups will be revealed to the researcher after the end of the statistical analysis to write the summary of the results. The results will be submitted to scientific journals afterward.
详细描述
Hypotheses:
Null hypothesis
H0: The time to T12 regression of the sensory block after administration of isobaric bupivacaine is EQUAL with or without the use of intravenous lidocaine in continuous infusion.
Alternative hypothesis
H1: The time to T12 regression of the sensory block after administration of isobaric bupivacaine is DIFFERENT depending on the use or not of intravenous lidocaine in continuous infusion.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigators appointed for executing the protocol will not have access to the group in which the patient will be allocated. Randomization will be performed by automated system (RedCap) and at the time the investigator assigned for preparing the medication in the central pharmacy of the unit is requested to send the infusion. Only staff in the pharmacy sector will have access to the allocation group. The groups will remain masked even after closing the database and sending the data sheet for statistical analysis by the principal investigator, there will be no identification of the intervention performed in each group (lidocaine versus saline solution). After the end of the analysis, the result will be opened to finish the description of the results and develop the discussion of the findings.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 85 years-old
- •The American Society of Anesthesiologists (ASA) physical status classification from I to III
- •To be submitted to:
- •- Spinal Anesthesia
- •- For surgeries performed by the Bone and Connective Tissue (TOC) service
- •- Involving lower limbs and inguinal region requiring sensory block level up to the T12 dermatome (except for larger amputations and bone resections)
- •- Expected duration of less than 120 minutes
- •- In supine position
- •That they voluntarily decide to participate in the study
排除标准
- •Coagulation disorder that prevents the execution of the blockade:
- •- International normalized ratio for prothrombin (INR) time and activity > 1.5
- •- Activated partial thromboplastin time ratio (PTTa) >1.5
- •- Use of enoxaparin up to 40mg/day less than 12h before the procedure
- •- Use of enoxaparin above 40mg/day less than 24hours before the procedure
- •- Use of oral anticoagulant or platelet aggregation inhibitors in a lower interval than recommended for spinal block
- •- Other coagulation disorders that prevent spinal anesthesia
- •Moderate or severe left ventricular systolic dysfunction (defined by the presence of left ventricle ejection fraction below 40%)
- •Sinus bradycardia (FC < 50 beats per minute)
- •Relevant cardiac conduction system disorders (e.g. atrium ventricular block greater than first-degree, Wolf-Parkinson-White syndrome)
- •Clinically significant arrhythmia (e.g. atrial fibrillation)
- •Body mass index (BMI) than > 35 mg.kg-1
- •Previous diagnosis of liver cirrhosis
- •Creatinine clearance < 30 ml/min/1.73m2 estimated by the method of the Modification of Diet in Renal Disease (MDRD) study group
- •Infection at the site of lumbar puncture
- •Previous spinal surgery
- •Allergy to local anesthetics amino-amides
- •Difficulty in communication, understanding or cognitive deficit that prevents adequate oral response to study the study forms
- •Pre-existing neurological lesion in topography to be evaluated motor block
- •Documented or suspected spinal or central nervous system metastasis
- •Regular use of strong opioids at a dose equal or greater than 60 mg of oral morphine equivalents per day
- •Desire to withdraw from the study at any time of its execution
研究组 & 干预措施
Group L (Lidocaine)
Lidocaine bolus 1.5 mg.kg-1 intravenous before the onset of lidocaine infusion Lidocaine 2mg.kg-1.h-1
干预措施: Lidocaine IV (Drug)
Group S (saline solution)
Lidocaine bolus 0.75 mg.kg-1 intravenous before the onset of saline infusion Saline solution infusion
干预措施: Saline (Drug)
结局指标
主要结局
Time to T12 regression of the sensory block
时间窗: Period: Day 0 postoperative
Time between the injection of bupivacaine into the subarachnoid space and the regression of sensory block to T12 dermatome (in minutes)
次要结局
- Nausea or vomiting(Between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours)
- Dizziness(From intraoperative to 24 postoperative hours)
- Time to the first opioid rescue(Intraoperative)
- Need for opioid analgesics (binary)(Between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours)
- Other arrhythmias(At the OR and admission to the PACU up to 24 postoperative hours)
- Propofol dose at the operating room(Intraoperative)
- Postoperative pain score at rest(Admission to the PACU, 2 postoperative hours, 24 postoperative hours, and worse in the first 24 postoperative hours measurements)
- Pain score at movement(24 postoperative hours)
- Time to motor block regression(Day 0 postoperative)
- Time to two-segment regression of the sensory block(Day 0 postoperative)
- Need for opioid analgesics (continuous)(between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours)
- Bradycardia(At the operating room (OR) and admission to the PACU up to 24 postoperative hours)
- Hypotension(At the OR, between 0 and 6 postoperative hours, between 6 and 24 postoperative hours, and between 0 and 24 postoperative hours)
- Urinary retention(Between 0 and 24 postoperative hours)
- Most rostral dermatome achieved by the sensory block(Day 0 postoperative)
- Quality of recovery in 24 hours(24 postoperative hours)
- Length of stay(Through study completion, an average of 30 days)