Catheter-based Peripheral Regional Anesthesia After Orthopedic Surgery to the Foot or Ankle: Comparison of Low Dose, Automated Periodic Infusions With Conventional High Dose, Continuous Infusion, and Patient-initiated Infusions Only
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Postoperative pain, 1-72 hours postoperatively
研究概览
简要总结
BACKGROUND
Orthopedic surgery can be severely painful, and peripheral regional anesthesia is highly recommended as part of the perioperative pain treatment. Whether catheter-based techniques are better than single injection techniques are debatable. Furthermore, in catheter-based techniques, whether a low-dose automated, periodic infusion can produce similar analgesic effectiveness compared to a conventional, high dose, continuous infusion has never been explored.
AIM
Comparison of the analgesic effectiveness of a low-dose automated, periodic infusion, a conventional continuous infusion and patient-controlled boluses only in catheter-based nerve blocks for patients undergoing orthopedic surgery to the foot or ankle.
详细描述
BACKGROUND
Orthopedic surgery has been reported to be moderate to severely painful in approximately 50 % of patients.
Peripheral regional anesthesia (PRA) using single injection nerve blocks is highly recommended as part of a multimodal, perioperative, analgesic treatment. Patients who are expected to have postoperative, severe pain exceeding the duration of a single injection nerve block may benefit from a catheter-based nerve block (CBNB) using either a continuous infusion (CI) or intermittent infusions of local anesthetics (LA). Intermittent boluses can be either patient-controlled or prescribed in combination with a continuous infusion or as prespecified intermittent boluses. Whether a CBNB treatment is superior to a single injection nerve block after orthopedic surgery remains unanswered.
There are several challenges when using a CBNB treatment: The dosing or delivery method may be either insufficient and thus not pain relieving or too powerful resulting in dense motor block and limb anesthesia which may compromise safety and rehabilitation. The peripheral nerve block catheter may also displace and therefore deposit LA too far from the targeted nerve(s) to produce an effective nerve block.
Previous studies suggest that an automated periodic infusion (API) regimen is superior to CI. It seems that an API produces better pain control, a lower analgesic consumption over time and less motor inhibition. This is well-described for epidural catheters for laboring women, but evidence is also apparent in PRA. Adding a PCA bolus option to a catheter-based nerve block treatment may even out the difference in pain scores between API and CI. However, it seems that API groups require less LA via PCA function. Reducing LA consumption is of great importance for ambulatory patients whose LA reservoir is limited, but also for all other orthopedic patients whose motor block should be minimized in order to optimize rehabilitation.
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)
盲法说明
All patients and outcome assessors will be blinded to the delivery administrations. Investigators will not be present while programming of the infusion pump is taking place. The display of the infusion pump will be concealed at all times after initiation. Furthermore, throughout the trial, the infusion pump will be concealed from the patient through a non-transparent bag. Trial interventions will not be visible in electronic patient charts. The infusion pump is making a discrete noise when administering medications. To make sure that the PCA group and the continuous infusion group is blinded to interventions, a sham administration is activated every 8th hour. This sham administration will be 0.1 mL of ropivacaine 0.2%. Such a small dose of LA will not have any anesthetic effect nor pose a risk for the patient.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists Classification I-III
- •Normal cognitive function in order to sign written, informed consent and to understand trial protocol
- •Agreement to the trial protocol, including the randomized manner
排除标准
- •Allergy to LA
- •Infection in or near insertion site of the peripheral nerve catheter
- •Anatomical abnormalities preventing successful peripheral nerve catheter insertion
- •Habitual use of opioids
- •Pregnancy or breastfeeding (disproved by a negative pregnancy test before trial inclusion)
研究组 & 干预措施
API+PCA
Infusion of ropivacaine 0.2 %, 10 mL, every 8th hour. Patient-initiated bolus of ropivacaine 0.2 %, 10 mL. Lock-out time: 4 hours.
干预措施: Ropivacaine 0.2% (Drug)
CI+PCA
Continuous infusion of ropivacaine 0.2 %, 6 mL/hour. Patient-initiated bolus of ropivacaine 0.2 %, 10 mL. Lock-out time: 4 hours.
干预措施: Ropivacaine 0.2% (Drug)
PCA only
Patient-initiated bolus of ropivacaine 0.2 %, 10 mL. Lock-out time: 4 hours.
干预措施: Ropivacaine 0.2% (Drug)
结局指标
主要结局
Postoperative pain, 1-72 hours postoperatively
时间窗: 1-72 hours
Postoperative pain using the visual analogue pain scale (VAS, 0-100 milimetres). Measurements will be patient-reported.
次要结局
- Opioid consumption, 1-72 hours postoperatively(1-72 hours)
- Volume of patient-initiated boluses, 1-72 hours postoperatively(1-72 hours)
研究者
Claus Behrend Christiansen
Medical doctor
Nordsjaellands Hospital