Can the Association of Dexamethasone and Local Anaesthetic in a Single-shot Femoral and Sciatic Nerve Block Improve Analgesia Postoperatively in Patients Submitted to Total Knee Arthroplasty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Quantification of Pain by VAS
研究概览
简要总结
Can the association of dexamethasone to the local anaesthetic in a single-shot femoral and sciatic nerve block improve analgesia postoperatively in patients submitted to total knee arthroplasty? Primary aim: Evaluate the efficacy of the association of dexamethasone to the local anaesthetic in a SSFNB and SSSNB in reducing pain scores, assessed by VAS.
Outcome measures: Mean pain scores in both groups. Secondary aims: Evaluate opioid consumption in the postoperative period (8- 12h, 24h, 48h) and assess incidence of side effects and complications (numbness, paraesthesias, weakness, site infection, haematoma and falls).
详细描述
All blocks are performed using nerve stimulation technique. For the SSFNB, the paravascular approach will be used to identify the femoral nerve.15 A positive location is considered when quadriceps contraction (patellar elevation) is elicited with a current of 0.4 mA or less, and 30mL of ropivacaine 0.375%, with or without 4mg of dexamethasone are injected, according to the randomization.
For the SSSNB the anterior approach will be chosen.16 The common peroneal or the tibial nerves are identified, respectively by dorsiflexion or plantar flexion of the foot, with a current of 0.4 mA or less. Depending on the allocated group, 20mL of ropivacaine 0.2%, with or without 4mg of dexamethasone are then injected. Blocks success should be assessed by the absence of thermal sensitivity on the anterior region of the thigh and the dorsum of the foot 10 minutes after the block.
The participating anaesthesiologists may use the ultrasound for visual guidance but should also use the nerve stimulator in order to maintain the homogeneity of the procedure.
Patients will then have an intravenous induction to general anesthesia, being the maintenance assured with either Desflurane or Sevoflurane. Thirty minutes before the end of the procedure all patients are given paracetamol 1000mg and ketorolac 30mg. Total doses of intraoperative analgesics are recorded.
Before surgery all patients will be explained how to use the PCA, which is connected after arrival to the post-anesthesia unit (PACU). The PCA is programmed for 1mg bolus as required by the patient, with a lockout period of 7 minutes. In what concerns the remaining post-operative analgesia, both groups are prescribed paracetamol 1000mg q8h, diclofenac 50mg q12h, and as rescue strategy, tramadol 100mg q6h.
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
- Single (Participant)
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
- •Adult patients admitted foi unilaterla total knee arthroplasty
排除标准
- •Refusal/Incapacity to give informed consent
- •Contra-indication to general anesthesia
- •Infection at needle insertion site
- •Coagulation disorders
- •Pre-existing neurologic disorders
- •Known allergy to any of the drugs from the protocol
- •ASA status >3
- •Weight<50kg
- •Inability to understand or use VAS pain score
研究组 & 干预措施
Local Anesthetic ropivacaíne
Femoral nerve block with ropivacaine 0.375% and sciatic nerve block with ropivacaine 0.2%
干预措施: Local Anesthetic ropivacaíne (Drug)
Perineural Dexamethasone
Femoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone
干预措施: Local Anesthetic ropivacaíne (Drug)
Perineural Dexamethasone
Femoral nerve block with ropivacaine 0.375% and perineural dexamethasone and sciatic nerve block with ropivacaine 0.2% and perineural dexamethasone
干预措施: Perineural Dexamethasone (Drug)
结局指标
主要结局
Quantification of Pain by VAS
时间窗: 48 hours
Pain assessed by VAS
次要结局
- Morphine consumption in mg(48 hours)
- Side-effects (numbness, paraesthesias, weakness, site infection, haematoma and falls)(48 hours)
- Complications from technique (Motor ou sensitive changes, infection, nausea)(48 hours)
研究者
Marta Carvalho
MD
Centro Hospitalar do Porto
