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临床试验/NCT04814303
NCT04814303Unknown不适用

Adductor Canal Block Versus Periarticular Infiltration Effect on Functional Outcome In Patients Undergoing Total Knee Replacement

Assiut University0 个研究点目标入组 200 人开始时间: 2021年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
200
主要终点
"Timed Up and Go" test (TUG)

研究概览

简要总结

TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain. Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery.

详细描述

Osteoarthritis (OA) of the knee has become a major public health issue and imposes a significant healthcare burden and accounts for high annual hospitalizations. Chronic OA of the knee may lead to reduced physical fitness, mobility disability with a resultant increased risk of cardio-metabolic comorbidity and early mortality. Total knee arthroplasty (TKA) is indicated in severe cases to improve long-term pain and function. (1) TKA involves extensive bone resection as well as soft tissue excision and therefore is associated with profound postoperative pain. (2) Inadequate perioperative pain control may prolong hospitalization, hinder early rehabilitation, and is also a strong predictor of persistent pain beyond 3 months. (3) Adequate analgesia after TKA is therefore considered paramount to facilitate early hospital discharge and effective functional recovery. (4) The recently introduced adductor canal block (ACB) typically covers the anterio-medial aspect of the knee and preserves quadriceps function, which presumably enhances postoperative rehabilitation by allowing patients to actively participate in knee movement. The relative effectiveness of this ACB technique added to intrathecal morphine is limited to a single study (1) in which assessment of short-term functional recovery was done and dexamethasone was neither included in the LIA solution nor perineurally in the ACB. Thus, we hypothesize that adductor canal block as an adjunct to intrathecal morphine will have a better impact on functional recovery than peri-articular infiltration.

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
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiologist class ( ASA) I - III
  • •BMI 18-35 kg/m2
  • •Scheduled for primary unilateral TKR

排除标准

  • •Known allergy to local anesthetics
  • •Contraindication to adductor canal block e.g. infection at the site of injection
  • •Contraindication to spinal anesthesia e.g. coagulopathy.
  • •Patients with pre-existing motor or sensory deficits in lower extremities.
  • •Patients who are morbidly obese (BMI≥35) because ultrasound-guided regional anesthesia could be technically difficult.
  • •Bilateral or revision total knee replacement
  • •Insulin or noninsulin-dependent diabetes mellitus.
  • •systemic corticosteroid use within 30-days of surgery

研究组 & 干预措施

ACB

Active Comparator

spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added. The block will be performed in the mid adductor canal to block both the saphenous and the nerve to vastus medialis. After skin infiltration with 1 to 2 mL of 2% lidocaine, an 80-mm, 22-gauge, the short-bevel echogenic needle is advanced in-plane with the ultrasound beam in an anterior-to-posterior direction until the tip is located within the adductor canal deep to the vastoadductor membrane. After negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection plane. The study solution will be injected within the canal adjacent to the femoral artery. Patients in this group received 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine and 4 mg dexamethasone.

干预措施: Adductor Canal block (Procedure)

PAI

Active Comparator

spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added. PAI intra-operatively will be performed with 150 mL of 0.25% bupivacaine with 1:400,000 epinephrine, 30 mg of ketorolac, and 8 mg dexamethasone.

干预措施: Peri-articular Infilteration (Procedure)

PAI

Active Comparator

spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added. PAI intra-operatively will be performed with 150 mL of 0.25% bupivacaine with 1:400,000 epinephrine, 30 mg of ketorolac, and 8 mg dexamethasone.

干预措施: Intrathecal morphine (Procedure)

ACB

Active Comparator

spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added. The block will be performed in the mid adductor canal to block both the saphenous and the nerve to vastus medialis. After skin infiltration with 1 to 2 mL of 2% lidocaine, an 80-mm, 22-gauge, the short-bevel echogenic needle is advanced in-plane with the ultrasound beam in an anterior-to-posterior direction until the tip is located within the adductor canal deep to the vastoadductor membrane. After negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection plane. The study solution will be injected within the canal adjacent to the femoral artery. Patients in this group received 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine and 4 mg dexamethasone.

干预措施: Intrathecal morphine (Procedure)

ITM

Active Comparator

spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral and Intrathecal morphine 150 μg will be added.

干预措施: Intrathecal morphine (Procedure)

结局指标

主要结局

"Timed Up and Go" test (TUG)

时间窗: 48 hours

reflects the time it takes a subject to stand up from a standard-height armchair, walk 3 m, walk back to the chair, and sit down.

次要结局

  • Visual analogue scale (VAS) at rest(72 hours)
  • Visual analogue scale (VAS) at movement(72 hours)
  • Time to first analgesic request(72 hours)
  • Total analgesic consumption(72 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shimaa Abbas Hassan

lectrure of Anesthesia

Assiut University

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