A Randomized Controlled Trial of Continuous Gastrocnemius Plane Block and Intravenous Analgesia After Foot and Ankle Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 主要终点
- Area under the pain intensity-time curve
研究概览
简要总结
This study aims to evaluate the efficacy and safety of a continuous gastrocnemius plane block for perioperative analgesia in patients undergoing foot and ankle surgery under elective general anesthesia.
详细描述
Anatomical studies show that the 0.2% methylene blue was injected into the upper and lower surface of the gastrocnemius muscle and then diffused to the periphery.The common peroneal nerve, the medial sural cutaneous nerve, the lateral sural cutaneous nerve and the tibial nerve below the gastrocnemius muscle are all strongly stained (3 / 4 color of the nerve) or fully stained.
Previous clinical studies have shown that a single gastrocnemius muscle plane block can provide good postoperative analgesia after 16 hours for patients with foot and ankle surgery, significantly reduce the dose of opioids, and see no nerve injury.
Therefore, the investigators hypothesized that continuous gastrocnemius plane block could provide more lasting analgesia in patients undergoing foot-ankle surgery.
This clinical study uses a single-center, randomized, single-blind, parallel controlled trial design, divided into screening period, treatment period and follow-up periods.
Patients were randomized into two groups, the ropivacaine group and the control group.The venous access was open after home invasion and was routinely monitored electrocardiogram(ECG), non-invasive blood pressure(NBP) ，oxygen saturation(SpO2)，bispectral index(BIS). General anesthesia was performed.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective foot and ankle surgery
- •Patient informed consent was obtained
- •Age 18 to 65 years Sex is not limited
- •American Society of Anesthesiologists(ASA)Ⅰ~Ⅲ level
- •Body Mass Index(BMI)18~28kg/m2
排除标准
- •Puncture site infection
- •Abnormal coagulation function
- •Local anesthetic allergy
- •Severe cardiopulmonary disease
- •Liver and renal insufficiency
- •Medical history of chronic pain
- •Long-term use of sedative and analgesic drugs
- •Communication disorders
- •The operation time exceeded 3 hours
研究组 & 干预措施
Experimental group: Ropivacaine-controlled analgesia pump
A single injection of 0.375% Ropivacaine 15 milliliters was given into the common peroneal nerve, medial sural cutaneous nerve, and lateral sural cutaneous nerve. Than，a catheter was placed in the gastrocnemius plane, and a 0.125% ropivacaine-controlled analgesic pump was applied.(The formulation was 0.125% ropivacaine at 300 milliliters, with a background dose of 3 milliliters/hours, a patient-controlled analgesia(PCA) dose of 8 milliliters, and a locking time of 25 minutes.）
干预措施: Continuous Gastrocnemius plane block with ropivacaine (Drug)
Control group: oxycodone-controlled analgesia pump
No treatment was given preoperatively, and postoperative oxycodone patient-controlled intravenous analgesia(PCIA). After awakening, intravenous oxycodone was titrated according to numerical rating scale(NRS) score, providing analgesia without background dose of oxycodone patient-controlled intravenous analgesia(PCIA) pump (single dose 1 milligram, locking time 5 minutes, 14 hours limit 12 milligrams)
干预措施: oxycodone (Drug)
结局指标
主要结局
Area under the pain intensity-time curve
时间窗: Up to 48 hours postoperative
The smaller the area under the pain intensity-time curve, the better the nerve block effect
次要结局
- Number of effective patient controlled analgesia (PCA) compressions(Up to 48 hours postoperative)
- Percentage of subjects without remedial analgesics(Up to 48 hours postoperative)
- The cumulative amount of remedial analgesic drugs (oxycodone) used(Up to 48 hours postoperative)
- The proportion of the number of invalid presses to the total presses(Up to 48 hours postoperative)
- Total number of patient controlled analgesia (PCA) presses(Up to 48 hours postoperative)
- Number of remedial analgesia(Up to 48 hours postoperative)