Comparison of the Effect of Intra-articular Administration of 0.2% Ropivacaine vs. 0.75% Ropivacaine as an Analgesic in the Immediate Postoperative Period of Knee Arthroscopy in Acute Injuries at the ABC Medical Center
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Number of Participants With Acute Pain (Visual Analogue Scale)
研究概览
简要总结
All patients with acute lesions that attend the orthopedic and trauma center of the ABC medical center are invited to participate in the study. Those that meet the inclusion criteria and later sign an informed consent are randomized to receive 10 ml of a solution with ropivacaine at 0.75% and 0.2% intraarticular for the first 5 minutes after the end of surgery (closing of surgical wounds). Both the patient, the physician who applies it and the evaluator of outcomes remain blinded to the dose of ropivacaine the patient receives.
Two hours after the end of the surgery, while the patient is in his room, the presence of pain is evaluated by a visual analog scale (VAS), while the patient is asked to flex and extend his knee. The result is quantified continuously, to later categorize the pain in none to slight pain (0-3 points) and moderate-severe pain (4-10 points). All the information is recorded on established forms in the clinical file (general data), that includes the variables of interest for the study, and is reported by the physicians after standardization of all those in charge with collecting information to comply with the conceptual and operative operationalization of the variables described in the research protocol. In addition to the evaluation of pain, the administration of opioids to patients for necessary reasons (presence of pain) by the physicians in charge is recorded.
It is hoped that, in patients with knee arthroscopy for acute lesion, there is a difference in the frequency of moderate-severe pain of 30% in the post-operative (frequency of 37.5% in patients with ropivacaine at 0.2% and frequency of 0.75% in patients with ropivacaine at 0.75%).
详细描述
In previous studies the prevalence of moderate-severe intensity pain in patients post knee arthroscopy is 71.2%, and the prevalence of acute pain in post-operative is 37.5%, surpassing the prevalence when compared with other surgical procedures of various specialties.
The administration of opioids is part of common practice in managing pain. However, it represents a risk for patients due to adverse effects and the high risk of dependence. It is necessary to seek alternatives that reduce the consumption of opioids in patients post knee arthroscopy.
Characteristics of the patients reported in other studies, such as sex, body mass index, sedentarism, the cause, duration and use of tourniquet in surgery, in addition to the type of lesion of articular cartilage and the presence of neuropathies, may influence in the presence of pain severity.
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
Masking was performed once the patient agreed to participate; the physician in charge of randomization informs the anesthesiologist of the maneuver that corresponds to the patient programmed for surgery, who prepares the dose for the patient and hands it to the physician who applies the maneuver (who is blinded to the maneuver). All patients receive 10 ml of solution with different doses of ropivacaine, the application vehicles being equal in physical appearance. The physician who evaluate the outcome does not participate in the randomization, surgery or application of the maneuver, and remains blinded to the dose the patient receives, as does the patient.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Mental health: healthy (not taking any medication)
- •Articular cartilage lesion Grade I, II or III by Outerbridge
- •Elective knee surgery
- •Patients with any of the following diagnoses:
- •Simple meniscal lesion
- •Lesion of a single knee (unilateral)
排除标准
- •Neuromotor diseases (alterations in step, strength or sensitivity)
- •History of knee surgery (orthopedic)
- •Instability that includes knee ligament lesions
- •Addictions
- •Mental diseases in medical treatment
- •Hepatic diseases
- •Allergy to any of the medications used in the study
- •Epidural or peridural anesthesia
- •Chronic pain in treatment
- •Postoperative drain of knee arthroscopy
- •Pregnant or lactating
研究组 & 干预措施
Ropivacaine 0.75% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.75%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
干预措施: Ropivacaine 0.75% Injectable Solution (Drug)
Ropivacaine 0.2% Injectable Solution
The patients receive 10 ml of intraarticular solution in the knee (at the anatomical point at the level of the upper pole of the ball joint, under the iliotibial band), with different content of ropivacaine 0.2%; the vehicle for application presents the same physical appearance for all patients and is applied by previously standardized treating physicians.
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
结局指标
主要结局
Number of Participants With Acute Pain (Visual Analogue Scale)
时间窗: 2 hours postoperative
The result is quantified continuously in a scale from 0 (No pain) to 10 (Worst pain imaginable) points. Acute pain is labeled of a value ≥4 points.
次要结局
- Number of Participants With Opioid Administration(2 hours postoperative)
研究者
Paola M Zamora Munoz
Principal Investigator
American British Cowdray Medical Center