Effect of Bupivacaine Liposomes or Bupivacaine for Femoral Triangle or Adductor Block on Analgesia After Total Knee Replacement: a Prospective, Single-center, Simple Randomized, Active-controlled, Single-blind, 2x2 Factorial Design Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Opioid consumption 72 hours after surgery
研究概览
简要总结
The purpose of this study was to investigate the effect of bupivacaine liposomes on postoperative pain in TKA ( total knee replacement ) patients.The main questions answered are:
- Is bupivacaine liposomes superior to bupivacaine in femoral triangle block or adductor block in terms of 72 hours opioid consumption after knee replacement
- Which block method(Femoral triangle block or adductor block) combined with bupivacaine liposome was more effective in alleviating pain score and 72 hours opioid consumption after total knee surgery.
investigators will investigate the effect of bupivacaine liposomes combined with bupivacaine and pure bupivacaine on pain after total knee arthroplasty using femoral triangle block or adductor block.
Participants will:
- Receive liposomal bupivacaine or bupivacaine as a regional anesthetic for femoral triangle block or adductor block under ultrasound guidance.
- Undergo total knee replacement surgery under spinal anesthesia.
- Follow-up within 72 hours after surgery , opioid consumption, NRS score, PCA（Patient controlled analgesia，PCA） data, first postoperative remedial analgesia time, quadriceps muscle strength and complications were recorded
详细描述
The patients received femoral triangle block plus iPACK(infiltration between popliteal artery and capsule of knee) block or adductor canal block plus iPACK block during induction .
The local anesthetic formulation was bupivacaine (0.75% bupivacaine hydrochloride 10ml+ normal saline 20ml) or bupivacaine liposome (0.75% bupivacaine hydrochloride 10ml+ bupivacaine liposome 20ml(266mg)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Double (Participant, Outcomes Assessor) . Given the distinct visual appearance of the liposomal bupivacaine (milky white) and bupivacaine (transparent), a double-blind study design is not feasible. Consequently, this study employs a single-blind approach where neither participants nor outcome assessors will be aware of treatment allocation. Healthcare providers administering the study drug will be aware of the treatment group assignment. Rigorous procedures will be implemented to minimize potential bias, including standardized outcome assessment tools, blinded data entry, and independent data analysis.
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 with ASAI-ⅲ
- •Receive a unilateral initial TKA
- •Age 18-80 years old -
排除标准
- •Bilateral TKA surgery
- •TKA revision surgery
- •Contraindications for nerve block and intraspinal anesthesia
- •Allergies to local anesthetics
- •Diabetic neuropathy
- •Patients who are unable to cooperate with the evaluation
- •Chronic use of opioid analgesics
- •BMI≥35kg/cm2
- •Cases of lumbar anesthesia failure requiring general anesthesia surgery
- •Cases of nerve block failure
研究组 & 干预措施
adductor block+ Bupivacaine liposomes and bupivacaine mixture
The patient underwent ultrasound-guided bupivacaine liposome mixture single adductor block during anesthesia induction room for analgesia after total knee arthroplasty .
干预措施: Bupivacaine liposome (Drug)
adductor block+ bupivacaine
The patient underwent ultrasound-guided bupivacaine single adductor block during anesthesia induction room for analgesia after total knee arthroplasty
干预措施: Bupivacaine (Drug)
femoral triangle block + Bupivacaine liposomes and bupivacaine mixture
The patient underwent ultrasound-guided bupivacaine liposome mixture single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty .
干预措施: Bupivacaine liposome (Drug)
femoral triangle block + bupivacaine
The patient underwent ultrasound-guided bupivacaine single femoral triangle block during anesthesia induction room for analgesia after total knee arthroplasty .
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Opioid consumption 72 hours after surgery
时间窗: this outcome will be monitored and recorded within 72 hours postoperatively
This primary outcome entails tracking and assessing the total opioid consumption by participants following total knee replacement surgery. The evaluation includes quantifying the amount of opioids prescribed and consumed by participants for pain management post-surgery. Opioid medications administered will be converted to morphine equivalents based on established conversion ratios. By analyzing overall opioid consumption, the study aims to evaluate the efficacy of the interventions in managing postoperative pain.
次要结局
- Pain intensity(Pain intensity will be measured at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery)
- Time to First Rescue Analgesic(72 hours after surgery)
- Total opioid dosage and PCA times(Total opioid dosage and PCA times were recorded at 8 time points: 6 hours, 12 hours, 18 hours and 24 hours 36 hours, 48 hours, 60 hours, 72 hours post-surgery)
- Quadriceps muscle strength(24.48,72 hours after surgery)
研究者
Wei Mei
clinical professor
Huazhong University of Science and Technology