Comparing the Effects of Adding Dexamethasone in 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Quadratus Lumborum Block
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 主要终点
- the post-operative analgesic effect of quadratus lumborum block
研究概览
简要总结
The quadratus lumborum block is widely used in abdominal surgery for post-operative analgesia. It is now also used for pain relief after hip surgery. Under the traditional blocking method, a high concentration of long-acting local anesthetic is used in order to achieve a long-term blocking effect. However, this is also likely to cause the patient's quadriceps weakness during the block period, increasing the risk of the patient falling during rehabilitation. It also increases systemic local anesthetic poisoning and may even trigger the risk of serious side effects such as cardiac arrest. Ropivacaine is a novel long-acting topical amine anesthetics that lasts long and has anesthetic and analgesic effects. Its pharmacological characteristics are low cardiotoxicity, sensory block and motor block separation at low concentrations more obvious, and with the external peripheral vasoconstriction. Therefore, the drug is especially suitable for postoperative analgesia.
Dexamethasone is a synthetic corticosteroid for the treatment of a wide range of symptoms including rheumatic diseases, certain skin diseases, severe allergies, asthma, chronic obstructive pulmonary disease, cerebral edema, and may also be combined with antibiotics for tuberculosis patients. It is becoming more common to use steroids as an adjuvant to local anesthetics in peripheral nerve block. Steroids have neurological blockade effects by blocking the nociceptive transmission of pith-type C-fibers and inhibiting the release of ectopic neurons. Dexamethasone, as a local anesthetic adjuvant in peripheral nerve block, has also been widely studied recently.
In order to reduce the incidence of long-acting topical anesthetics from the nerve block in the quadratus lumborum block, reducing the local anesthetic concentration is a feasible method. However, this will also result in a shorter time to neurological block. The investigators hypothesized that the addition of Dexamethasone 5 mg to low concentrations (0.25%) of Ropivacaine would prolong postoperative analgesia. Therefore, the purpose of this study was to compare the postoperative analgesia and the side effects of postoperative quadratus lumborum block with the addition of Dexamethasone 4mg to Ropivacaine (0.25%) in low concentrations and Ropivacaine (0.5%) alone.
详细描述
Test drug:
- Name: Dexamethasone sod. Phosphate
- Dosage form: 5 milligram (mg)/1 milliliter (mL)/Amp
- Dose(s): 4mg
- Dosing schedule: Dexamethasone 4mg adds into 0.25% Ropivacaine 20 mL
- Mechanism of action: Synthesis of adrenocortical hormones, has a strong anti-inflammatory effect, can prolong the effect of local anesthetic drugs
- Pharmacological category: HS051 Glucocorticoids
Study design:
- ☑ Control: ☑ placebo（N/S 0.8 mL + 0.25% Ropivacaine 20 mL）
- active (Dexamethasone 4mg＋0.25% Ropivacaine 20 mL)
- others（N/S 0.8 mL + 0. 5% Ropivacaine 20 mL） □ Uncontrolled 2. Blinding: □ open-label □ single blind ☑ double blind □ others 3. Randomized: ☑ yes □ no 4. ☑ Parallel □ cross-over □ others 5. Duration of study：from Institutional Review Board (IRB) approval ~to 12, 31, 2022 ,total 24 months Duration of Enrollment : from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of treatment：from IRB approval ~to 12, 31, 2022 ,total 24 months Duration of follow-up: from IRB approval ~to 12, 31, 2022 ,total 24 months
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)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) classification: I ~ III
- •Patients who received quadratus lumborum block for post-hip surgery analgesia
排除标准
- •Lumbar plexus degeneration,
- •Coagulation abnormalities with international normalized ratio (INR) > 1.5
- •Obvious heart, lung, liver or kidney disease
- •Body mass index less than 18.5 or greater than 35
- •Pregnancy
- •Regular use of steroids or opiates Opioids
- •Chronic medication or alcohol abuse
- •Previous allergies or adverse reactions to opiates, dexamethasone, or ropivacaine
结局指标
主要结局
the post-operative analgesic effect of quadratus lumborum block
时间窗: Within 48 hours after surgery
1. The pain will be assessed using a 0 to 10 Numerical Rating Scale (NRS) 2. In an hour in the recovery room, the pain will be evaluated every 15 minutes. 3. Then the pain will be assessed at the 3rd, 6th, 12th, 24th, 36th, and 48th hours after surgery.
次要结局
未报告次要终点