Comparison of the Effectiveness of the Use of Ropivacaine and Midazolam by Intraarticular vs Epidural Administration on Post-operative Analgesia After Isolated Arthroscopic ACL Reconstruction With Hamstring Autograft.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Post-operative analgesic request
研究概览
简要总结
Compare of the effectiveness of the use of ropivacaine and midazolam by intraarticular vs epidural administration on post-operative analgesia after isolated arthroscopic anterior cruciate ligament (ACL) reconstruction with hamstring autograft.
详细描述
Anterior cruciate ligament (ACL) reconstruction is a common surgical knee procedure that presents moderate to severe postoperative pain, additionally, an adequate control of the pain is required to start intensive rehabilitation after the surgery, early hospital discharge and reduction of the administration of oral and intravenous anesthetic drugs.
Postoperative pain is a common upsetting symptom following ACL reconstruction that delay return to daily activity of the patient and leads to an increase in days of hospitalization and early rehabilitation.(Harris et al., 2014) Therefore, pain is also mediated by free nerve endings in the knee joint, which are located in the tendons of semitendinosus, gracilis and sartorius muscles, associated with higher pain in comparison with ACL allograft.(Hong et al., 2019) For effective, safe and longer post-ACL reconstruction analgesia, several analgesic strategies such as systemic medication, central or peripheral blocks, and intra-articular drug administration have been used to control the pain. (Baverel et al., 2016; Dauri et al., 2003; Parker et al., 2007; Peng et al., 2018; Zhou et al., 2016; Zou et al., 2016) Combined spinal anesthesia is better option for knee surgery, it can reduce the disadvantages of general and alone spinal or epidural anesthesia. Combined spinal anesthesia appears to be effective and with lower toxicity than general anesthesia. (Baldawi et al., 2020; Johnson et al., 2016; Moucha et al., 2016; Padwal et al., 2019) Moreover, reduce the hospital stay and extends the analgesia into the postoperative period without increasing morbidity. (Johnson et al., 2016)
HYPOTHESIS: The hypothesis was that there are differences in the quality and quantity of postoperative pain in knee arthroscopy surgery when midazolam plus ropivacaine is administered epidurally, in comparison to ropivacaine and midazolam by intraarticular.
Methodology:
Type of study: Controlled clinical trial. Study design: Experimental, longitudinal, comparative, prospective and double blind.
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
- Double (Participant, Investigator)
盲法说明
Prior to being included in the study, the patient will be mentioned the times when he will receive the medication as well as the dosage of administration. The patient will not know what medication is being administered to him / her. The drug will be given to the anesthesist in unlabeled syringes without access to any information legend. In the same way, the study group only will be know by a doctor outside the research protocol and will not participate in any other phase of the study so that no member of the research team will know what medication was administered.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years and younger than 50 years
- •Arthroscopic single bundle anterior cruciate ligament anatomic reconstruction with hamstring tendon autograft
- •Unilateral procedure
- •With or without meniscal tear
- •Desire to participate voluntarily in the study and signature of informed consent
- •Pre-operative assessment with result between (American Society of Anesthesiologist) ASA I or ASA II performed and annexed in the clinical file either by the Department of Internal Medicine, Cardiology or Anesthesiology.
排除标准
- •Another ligament surgery (posterior cruciate ligament, medial collateral ligament, posterolateral corner reconstruction)
- •ACL reconstruction with allograft
- •Bone to bone or quadriceps autograft
- •ACL reconstruction with double bundle technique
- •Patients with previous knee surgeries
- •Open ACL reconstruction
- •Corrective knee osteotomy or articular cartilage repair surgery, meniscal transplant, lateral extraarticular tenodesis
- •Pregnant or lactating patients
- •Patients under 18 years old
- •Patients consuming oral contraceptives
- •Patients who present any contraindication for neuraxial blockade (e.g., coagulation defects, infection at the puncture site, pre-existing neurological deficits in the lower extremities, Anticoagulant or antiplatelet therapy that has not been suspended 48 hours before the surgery, systemic infection, fever above 38.5º)
- •Preoperative assessment with ASA III-IV
- •Hypersensitivity to the drugs used in the study
- •Patients with intellectual impairments or psychiatric conditions that limited adequate communication
- •Patients with a diagnosis of fibromyalgia, polymyalgia rheumatica, complex painful syndromes or sciatic neuropathy
研究组 & 干预措施
Ropivacaine and midazolam epidural administration
An elastomeric pump was prepared for epidural infusion. This was prepared with 150 mg (20 ml) of 0.75% ropivacaine plus midazolam at 50 mcg / kg / 12 hrs. The solution was made up to 125 ml with physiological solution.
And 20 ml of physiological solution, was intraarticular administered as placebo.
干预措施: ropivacaine and midazolam epidural administration (Drug)
Ropivacaine and midazolam intraarticular administration
Ropivacaine 0.75% at 1.5 mg / kg was used with midazolam at 50 mcg / kg, to complete 20 ml of solution and was administrated on the knee articulation after tourniquet release.
And an elastomeric pump was prepared for epidural infusion, with 150 ml of physiological solution as placebo.
干预措施: ropivacaine and midazolam intraarticular administration (Drug)
结局指标
主要结局
Post-operative analgesic request
时间窗: will be measured at 24 hours after surgery
All the medication utilized posterior to the surgery was recorded and administered in case of pain with a VAS greater than 4, the administration of 1g of acetaminophen, 30 mg IV of ketorolac and 50 mg IV of Tramadol was indicated, in any of the 2 groups, which could be repeated every 8 hours if required.
次要结局
- Therapeutic effect on visual analog scale(Pain will be measured at 2, 6, 12 , 24 and 48 hours after surgery.)
- Post-operative analgesic request(will be measured at 2, 6, 12 , 24 and 48 hours after surgery.)
- Side effects of analgesic drugs(Hemoglobin levels will be measured at 2, 6, 12 , 24 and 48 hours after surgery.])
- Postoperative range of motion(at 24 and 48 hours after surgery.])
研究者
Rodolfo Morales Avalos
MD, MSc
Universidad Autonoma de Nuevo Leon