Continuous Infusion Versus Automated Intermittent Bolus of Levobupivacaine 0,1% in Ultrasound Guided Subparaneural Sciatic Nerve Catheters. A Prospective Double Blind Randomised Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- local anesthetic dose in 48 hours
研究概览
简要总结
This study is developed to determine if the local anaesthetic dose can be reduced by the use of intermittent bolus technique compared to continuous infusion when the nerve catheter is placed underneath the paraneurium by ultrasound guidance in the popliteal fossa. Our primary outcome is local anesthetic use the first 48 hours after connecting the peripheral nerve catheter. Our hypothesis is that with an intermittent bolus less local anaesthetic is necessary the first postoperative 48 hours after surgery for adequate postoperative analgesia. As secondary outcomes the investigators study pain scores, motor block, sensory block, feeling of numbness, patient satisfaction, sleep quality and rescue analgesia during the nerve block and afterwards.
详细描述
Patients scheduled for foot surgery under general anaesthesia and a popliteal nerve catheter will be asked to take part and give informed consent. The anaesthesiologist performing the block, the patient and the independent observer will be blinded to the study group and the settings of the pump (CADD®-Solis) will be regulated and the data collected after 48 hours by an independent pain nurse or anaesthetist who is aware of the study group but does not register any other parameters.
Patients will be randomised by a computer-generated sequence, concealed by sealed envelopes. The envelope will be opened and the pump prepared by an independent pain nurse or anaesthesiologist who will not participate in registration of the parameters except extracting information out of the pump when the catheter is removed.
We expect to detect a 20 % increase in local anaesthetic dose for the continuous administration group (230 mg/48 hour). We used a standard deviation of 25%(58 mg) from a previous study. The minimum sample size required is 20 patients per group for a power of 80% with a 2-tailed significance level of 5%. We decided to include 25 patients in each group.
Before surgery
An IV access and standard monitoring is used throughout the procedure. A pre puncture scan will be performed and an experienced anaesthesiologist will perform all blocks. The block is performed in the lateral decubitus with a 12-18 MHz (megahertz) linear probe (BK medical®) and a solo long needle-catheter set (Pajunk®,18 gauge needle, 20 gauge catheter). The nerve will be visualised in a short axis image and the puncture will be done out of plane. Confirmation of accurate needle tip position will be confirmed by injection of nacl 0,9% (sodium chloride) and the appearance of a "twin- or triple halo sign". After confirmation of correct needle tip position 15 ml levobupivacaine 0,25% (chirocaine® Abbot)will be injected in between de peroneal and tibial nerve as an initial bolus. After injection a will be advanced 4 cm beyond the needle tip.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, 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
- 是
入选标准
- •scheduled for for surgery for hallux valgus pathology with general anesthesia and a popliteal nerve catheter (=sciatic nerve block)
排除标准
- •neuromuscular disease,
- •chronic pain,
- •peripheral neuropathy in lower limb,
- •contraindication for popliteal nerve block,
- •unable to use pca (patient controlled analgesia),
- •patient refusal
研究组 & 干预措施
C group
continuous infusion of levobupivacaine
干预措施: continuous infusion of levobupivacaine (Drug)
B group
Intermittent bolus infusion of levobupivacaine
干预措施: Intermittent bolus infusion of levobupivacaine (Drug)
结局指标
主要结局
local anesthetic dose in 48 hours
时间窗: 48 hours
the total amount of local anesthetic dose (mg) in total administered by the pump connected to the sciatic nerve catheter from start of the pump until stop ( 48 hours after start)
次要结局
- pains scores(48 hours)
- motor block (possibility of tow movement ( yes/no)(48 hours)
- sensory block loss of cold sensation (yes/no)(48 hours)
- numbness (sensation of numbness (0 = no, 1= yes but not disturbing, 2= yes and disturbing)(48 hours)
- patient satisfaction 9satisfaction on a 10 point scal ( 0= very dissatisfied, 10 = very satisfied)(48 hours)
研究者
Dr M. B. Breebaart
MD
University Hospital, Antwerp