Perineural Dexamethasone in the Adductor Canal Block for Postoperative Pain in Knee Arthroplasty Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- morphine consumption
研究概览
简要总结
Postoperative pain management in total knee arthroplasty (TKA) surgery is a real challenge for the anesthesiologist. Effective pain control must be provided while preserving the mobility to ensure early rehabilitation. The adductor canal block is an effective way to induce sensory block without motor block. However, the major disadvantage of this block is the duration of sensory block which may be insufficient for postoperative pain management in TKA surgery. Many studies have focused on finding molecules that can prolong sensory block without the need for a perineural catheter and dexamethasone is among the most studied molecules(1, 2). Hence, our study aims to evaluate the added value of perineural dexamethasone in the adductor canal block in TKA surgery.
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详细描述
Using a computer-generated sequence of random numbers, the patients included will be randomly allocated to get an adductor canal block using :
Group D: 10 ml of 0.5% bupivacaine + 10 ml of 0.9% normal saline solution + 8 mg of dexamethasone (equivalent to 2 ml) Group C: 10 ml of 0.5% bupivacaine + 10 ml of 0.9% normal saline solution + 2 ml of 0.9% normal saline solution
All patients included in the study will initially be evaluated at the anesthesia outpatient clinic with correction of any existing health issues. A pre-anesthesia visit will be conducted the day before the procedure for all patients, providing them with information about the protocol of our study and obtaining their consent to participate.
Upon arrival at the operating room, non-invasive monitoring of blood pressure, pulse oximetry, and ECG tracing will be performed and also a blood glucose level measurement. An 18-gauge peripheral intravenous line will be established, and 0.03 mg per kg midazolam was administrated.
All patients will receive spinal anesthesia. Depending on the patient's condition, investigators will opte for:
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral TKA
- •Surgery under spinal anesthesia
- •ASA class I, II, and III patients
排除标准
- •Patient refusal to participate in the study
- •Contraindication to regional anesthesia
- •Allergies to the products used
- •Bilateral TKA
- •Revision TKA
- •TKA in the context of inflammatory or post-traumatic disease
- •BMI > 45
- •Poorly controlled diabetic patients with HbA1c > 8%
- •Patients on corticosteroid therapy or who have received an intra-articular injection of corticosteroids
结局指标
主要结局
morphine consumption
时间窗: 48 hours
postoperative consumption of morphine
次要结局
- NRS on mouvement(1 hour, 3 hous, 6 hours, 9 hours,12 hours, 24 hours, 36 houes and 48 hours postoperatively)
- Blood glucose level(1 hour, 6 hours,12 hours,18 hours, 24 hours postoperatively)
- walk(day 1 and day 2 postoperatively)
- knee mouvement(preoperatively, on day 1 and day 7 postoperatively)
- postoperative quality of life(6 months)
- Patient's satisfaction(48 hours postoperatively)
- pain at home(7 days postoperatively)
- quality of recovery(day one)
- neuropathic Chronic pain(6 MONTHS)
- chronic pain(6 months)
- knee fonction(6 months)
- NRS at rest(1 hour, 3 hours, 6 hours, 9 hours,12 hours, 24 hours, 36 hours and 48 hours postoperatively)
研究者
Olfa kaabachi, MD
PROFESSOR
University Tunis El Manar