Comparison of Visibility of Echogenic and Standard Non-echogenic Block Needles During Ultrasound Guided Sciatic Blocks. A Randomized Prospective Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Visibility of needle tip and catheter tip
研究概览
简要总结
Patients scheduled for total knee replacements and suitable for sciatic nerve block will be randomized to one of 2 groups.
Group 1 will have the nerve block performed using a standard Pajunk block needle under ultrasound guidance and with electrical nerve stimulation (ENS), and have catheter placement also guided by electrical nerve stimulation. Group 2 will have the block performed using a Sonoplex echogenic block needle and have an echogenic catheter sited, all under ultrasound (US) guidance. Group 2 will have needle location aided by ENS, but ENS will not be used for catheter location.
An observer blinded to the needle type will assess the quality of needle visualisation on a recording of the US image taken during the procedure, along with adequacy of spread of local anesthetic. The primary outcome will be needle visibility, and secondary outcomes will be block success rate, block performance time, complication rate, number of needle passes per block, and adequacy of spread of local anesthetic.
详细描述
A total of 70 patients with ASA physical status 1 to 4, scheduled for elective total knee arthroplasty and deemed suitable to receive a sciatic nerve block will be included in the study. They will be randomised to one of two groups prior to the block procedure using a closed envelope system.
Recruitment will take place in the preoperative clinic. All blocks will be performed in the block room using standard monitoring, sterile precautions and titrated intravenous sedation.
Prior to the sciatic nerve block a continuous femoral nerve block will be performed according to standard procedure. Once this is complete the patient will be positioned for the sciatic nerve block.
A preprocedural scan will be done as per standard practice and skin will be infiltrated with 1% lidocaine.
The anaesthetist performing the block will be aware of the study group allocation due to the requirement for physically handling the block needles, and will proceed to position the needle into the required location site to facilitate catheter insertion, with the aid of electrical nerve stimulation via the needle. This will be recorded using the ultrasound machines cineloop facility.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18-80 years listed for total knee arthroplasty.
- •ASA I-IV.
- •Able to give informed consent
- •Able to cooperate with study protocol.
排除标准
- •Standard contraindication to regional anaesthesia/analgesia: local infection, coagulopathy, local anaesthetic allergy, patient refusal, diabetes mellitus, peripheral neuropathy, pre-existing nerve injury)
- •Inability to consent
- •Patient refusal
- •Pregnant patients
研究组 & 干预措施
Echogenic needle and catheter
The echogenic needle will be positioned using ultrasonography and neurostimulation with an end point of plantar or dorsiflexion with 0.6mA of current strength. The catheter will be inserted using ultrasonography alone. 20 Ml of 2% mepivacaine will be inserted using the catheter. The distribution of drug will be evaluated using short axis and long axis views. Sensory motor block evaluation every 5 minutes for 30 minutes. Duration of block procedure, number of passes and success will be evaluated
干预措施: echogenic needle and catheter (Device)
Neurostimulation
The non echogenic needle will be positioned using ultrasonography and neurostimulation with plantar or dorsiflexion as the end point with 0.6mA current.The catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current.
干预措施: Neurostimulation to position needle and catheter (Device)
结局指标
主要结局
Visibility of needle tip and catheter tip
时间窗: Day 1
Needle tip visibility graded by blinded observers Catheter tip visibility graded by blinded observers
次要结局
- number of needle passes(Day 1)
- success rate of block(Day 1)
- Block procedure time(Day 1)
- Immediate complications(Day 1)
- delayed complications(One week after surgery/block)
研究者
Sugantha Ganapathy
Professor
Lawson Health Research Institute