Effect of Dexamethasone on Duration of Analgesia After Ultrasound-Guided Femoral, Obturator, and Popliteal Blocks With Ropivacaine in Total Knee Arthroplasty
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Duration of Analgesia
研究概览
简要总结
This is a Randomized Double blinded controlled trial on the effect of adding dexamethasone to Ropivacaine on the duration of pain relief for ultrasound guided femoral, obturator and popliteal block after total knee replacement surgery.
详细描述
This is a double blinded randomized controlled trial on the effect on duration of action when we add dexamethasone to our 3 routine peripheral nerve blocks (femoral, obturator and sciatic nerve) for total knee replacement surgery.
Technique:
A computer generated randomization will determine if dexamethasone 8mg (2 cc of 4mg/cc) will be given to the patient intravenously or mixed with the ropivacaine for the lower limb blocks. A sham 2 ml of normal saline will be given in the other route. For example, if the patient is assigned to the Ropivacaine + Dexamethasone Combination arm, 2 ml of dexamethasone will be drawn up and labeled "PNB" (peripheral nerve block) by a person not involved in the block or anesthetic management of the patient and given to the regional anesthesiologist to add to their local anesthetic solution. Another 2 ml of normal saline labeled (IV) will be drawn up by the same person and the sham will be given to the anesthesia team taking care of the patient during surgery for them to give it to the patient intravenously just before the start of the surgery.
Alternatively, if the patient is assigned to the Ropivacaine-Only Block arm, a person not involved in the patient care will draw up 2 ml of normal saline and label it "PNB" and give it to the regional anesthesiologist and 2ml of dexamethasone and label it "IV" to the anesthesia team taking care of the patient during surgery for them to give it to the patient intravenously just before the start of surgery.
Randomization:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists physical status I to III,
- •Aged 18 and above,
- •Undergoing total knee replacement.
排除标准
- •Body mass index of more than 45 kg/m2 (higher chance of failure)
- •Weight less than 70 kg
- •Injection site deformities
- •Infection at the injection site
- •Existing peripheral neuropathy
- •Allergy to LA agents
- •Contraindications to dexamethasone
- •Patients with severe PONV
- •Patients with peptic ulceration or upper GI bleed of unknown origin
- •Coagulopathy
- •Any other contraindication to lower limb peripheral nerve block
研究组 & 干预措施
Ropivacaine + Dexamethasone Combination
干预措施: Dexamethasone (Drug)
Ropivacaine-Only Block
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Duration of Analgesia
时间窗: 72 hours or first report of pain in the knee which ever is earliest
Duration of analgesia defined as the time interval between the end of local anesthetic injection and the patient's first report of pain in the knee.
次要结局
- Duration of motor blockade(72 hour or first return of motor function)
- Duration of sensory blockade(72 hours or first report of sensory recovery)
- Complete sensory return(72 hours or when the patient first reports complete sensation)
研究者
Nicholas Lam
Associate Professor
University of New Mexico