Multimodal Analgesia for Unilateral Total Knee Arthroplasty: Impact of Continuous Adductor Canal Infusion Combined With NSAID vs. Intravenous Morphine Patient-controlled Analgesia Combined With Single-injection Adductor Canal Block
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Pain scores at rest and motion
研究概览
简要总结
Multimodal analgesia (MMA) has been endorsed to improve postoperative analgesia and functional activity after surgery, and integrating regional analgesia to reduce the consumption of opioid has also been used in postoperative pain management. The investigator try to find a better combination of MMA for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan, therefore the effect of single-injection and continuous infusion of peripheral nerve block is compared in patient undergoing unilateral TKA. The investigators hypothesize that continuous adductor canal infusion is as effective as single-injection adductor canal block for postoperative pain relief under intravenous PCA after TKA surgery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.
详细描述
The study compares the effect of two multimodal analgesia protocols, the one integrating IVPCA morphine with single-injection adductor canal block and the other integrating continuous adductor canal infusion with timely administered intravenous tenoxicam, on postoperative analgesia and functional activity after TKA. To assess the outcome of both modalities, The investigators can have more comparative result of pain score and other functional parameters like range of motion of knee joint and muscle strength. Based on that, the investigators try to find a better multimodal analgesic approach for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan. The investigators hypothesize that multimodal analgesia using continuous adductor canal infusion and intravenous tenoxicam are as effective as another modality using IVPCA and single-injection adductor canal block for postoperative pain relief after TKA surgery. However, continuous adductor canal infusion integrated with intravenous tenoxicam might reduce the occurrence of opioid-related side effect and enhance the functional recovery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.
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
- None
入排标准
- 年龄范围
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of knee osteoarthritis
- •Must be aged between 20 to 90 years old
- •Must be scheduled for unilateral total knee arthroplasty surgery
- •Must agree to enroll into the clinical trial and have signed the written informed consent
排除标准
- •American Society of Anesthesiologists physical status class IV-V
- •Elevated liver enzymes or liver failure
- •Renal dysfunction (serum creatinine level ≥ 1.5 mg/dL)
- •Cardiac failure
- •Organ transplantation recipient
- •Major neurological deficit with lower extremity muscle weakness
- •Sensory and motor disorders in lower limb
- •Coagulopathy or thrombocytopenia
- •Previous drug dependency
- •Patients who used illicit drugs within six months
- •Chronic use of opioids
- •Allergy to local anesthetics and drug used in experiment
- •Inability to walk independently
- •Inability to comprehend pain assessment
- •Refusal for implanting a continuous peripheral nerve catheter
- •Refusal for enrolling in study
研究组 & 干预措施
Single-injection ACB combined with IV-PCA morphine
Allocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management.
干预措施: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees. (Behavioral)
Single-injection ACB combined with IV-PCA morphine
Allocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management.
干预措施: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale (Other)
Single-injection ACB combined with IV-PCA morphine
Allocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management.
干预措施: Rehabilitation physiotherapy (Behavioral)
Continuous adductor canal infusion combined with intravenous NSAID
Allocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management.
干预措施: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees. (Behavioral)
Continuous adductor canal infusion combined with intravenous NSAID
Allocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management.
干预措施: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale (Other)
Continuous adductor canal infusion combined with intravenous NSAID
Allocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management.
干预措施: Rehabilitation physiotherapy (Behavioral)
结局指标
主要结局
Change in Pain scores at rest and motion
时间窗: Month 3 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Baseline (day of admission)
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Hour 2 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Hour 8 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Hour 24 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Hour 36 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Hour 48 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Hour 60 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: Hour 72 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
Change in Pain scores at rest and motion
时间窗: 1 day of discharge
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable.
次要结局
- Rehabilitation physiotherapy: Single leg stance test(Month 3 after surgery)
- Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index(Month 3 after surgery)
- Rehabilitation physiotherapy: Knee flexion angle(Month 3 after surgery)
- Rehabilitation physiotherapy: knee muscle strength(Month 3 after surgery)
- Functional questionnaire: Brief pain inventory (BPI) short form(Month 3 after surgery)
- Adverse events(Month 3 after surgery)
- Rehabilitation physiotherapy: Six minute walk test(Month 3 after surgery)
- Functional questionnaire: Lower extremity functional scale(Month 3 after surgery)
- Rehabilitation physiotherapy: Knee flexion angle(Baseline (day of admission))
- Rehabilitation physiotherapy: Knee flexion angle(Hour 24 after surgery)
- Rehabilitation physiotherapy: Knee flexion angle(Hour 72 after surgery)
- Rehabilitation physiotherapy: Knee flexion angle(1 Day of discharge)
- Rehabilitation physiotherapy: knee muscle strength(Baseline (day of admission))
- Rehabilitation physiotherapy: knee muscle strength(Hour 24 after surgery)
- Rehabilitation physiotherapy: knee muscle strength(Hour 72 after surgery)
- Rehabilitation physiotherapy: knee muscle strength(1 day of discharge)
- Rehabilitation physiotherapy: Six minute walk test(Baseline (day of admission))
- Rehabilitation physiotherapy: Six minute walk test(Hour 24 after surgery)
- Rehabilitation physiotherapy: Six minute walk test(Hour 72 after surgery)
- Rehabilitation physiotherapy: Six minute walk test(1 date of discharge)
- Rehabilitation physiotherapy: Single leg stance test(Baseline (day of admission))
- Rehabilitation physiotherapy: Single leg stance test(Hour 24 after surgery)
- Rehabilitation physiotherapy: Single leg stance test(Hour 72 after surgery)
- Rehabilitation physiotherapy: Single leg stance test(1 day of discharge)
- Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index(Baseline (day of admission))
- Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index(1 day of discharge)
- Functional questionnaire: Brief pain inventory (BPI) short form(Baseline (day of admission))
- Functional questionnaire: Brief pain inventory (BPI) short form(1 day of discharge)
- Functional questionnaire: Lower extremity functional scale(Baseline (day of admission))
- Functional questionnaire: Lower extremity functional scale(1 date of discharge)
- Adverse events(Baseline (day of admission))
- Adverse events(Hour 2 after surgery)
- Adverse events(Hour 8 after surgery)
- Adverse events(Hour 24 after surgery)
- Adverse events(Hour 36 after surgery)
- Adverse events(Hour 48 after surgery)
- Adverse events(Hour 60 after surgery)
- Adverse events(Hour 72 after surgery)
- Adverse events(1 day of discharge)