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临床试验/NCT05447871
NCT05447871Unknown不适用

Single-injection Modified 4 in 1 Block Versus Adductor Canal Block as Postoperative Analgesia in Total Knee Arthroplasty

Mansoura University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
90
试验地点
1
主要终点
Total amount of postoperative analgesia in first 24 hours

研究概览

简要总结

Patients suffer from moderate to severe pain after TKA. Patients are asked to begin functional exercise as early as possible after surgery, and that requires adequate control of postoperative pain. Regional anesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK but these blocks have many drawbacks.

So new studies found that a modified 4 in-1 block blocks all these nerves and produces adequate analgesia without sparing areas.

详细描述

Total knee arthroplasty (TKA) is regarded as the most effective method to reduce knee pain and improve knee function in patients with advanced knee osteoarthritis. Postoperative pain is an unpleasant experience for TKA and this pain might greatly influence patients' early rehabilitation.

Almost 60% of patients suffer moderate to severe pain after TKA and 25% of them could even develop related complications, such as longer hospitalization stays, unanticipated hospital admissions, readmissions, etc.

With the development of enhanced recovery after surgery, patients are asked to begin exercise as early as possible after surgery, and that requires adequate control of postoperative pain.

Multimodal systemic analgesia plays an essential role in controlling postoperative pain after TKA by controlling the inflammatory process, dealing with the neuropathic component of pain, and thus reducing the severity of pain.

Multimodal analgesia includes more than one pain-control modality (systemic analgesia and regional anaesthesia). Systemic analgesia includes acetaminophen, nonsteroidal anti-inflammatory drugs, steroids and opioids. Regional anaesthesia includes epidural analgesia, femoral n. block, adductor canal block, sciatic n. block, IPACK, etc. Regional anaesthesia divides into non-motor sparing peripheral nerve blocks as femoral n. block and sciatic n. block and motor sparing peripheral nerve block as adductor canal block and IPACK.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

盲法说明

Single blind (participant) study

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Body mass index (BMI) of 19-30 kg/m2
  • American Society of Anesthesiologists (ASA) functional status of I-III

排除标准

  • Drug hypersensitivity
  • coagulopathy
  • infection at the site of injection
  • Traumatic arthirits

研究组 & 干预措施

Ultrasound guided single injection modified 4 in 1 block technique

Experimental

Patients in this group will receive ultrasound guided single injection modified 4 in 1 block with 25 ml bupivacaine 0.25%

干预措施: Ultrasound guided single injection modified 4 in 1 block technique (Procedure)

Ultrasound guided single injection modified 4 in 1 block technique

Experimental

Patients in this group will receive ultrasound guided single injection modified 4 in 1 block with 25 ml bupivacaine 0.25%

干预措施: Bupivacaine 0.25% (Drug)

Ultrasound guided adductor canal block technique

Active Comparator

Patients in this group will receive ultrasound guided aduuctor canal block with 20 ml bupivacaine 0.25%

干预措施: Ultrasound guided adductor canal block technique (Procedure)

Ultrasound guided adductor canal block technique

Active Comparator

Patients in this group will receive ultrasound guided aduuctor canal block with 20 ml bupivacaine 0.25%

干预措施: Bupivacaine 0.25% (Drug)

结局指标

主要结局

Total amount of postoperative analgesia in first 24 hours

时间窗: in first 24 hours

calculate total amount of morphine hydrochloride which patient will need in first 24 hours postoperative.

次要结局

  • intraoperative non invasive blood pressure(NIBP) mmHg(every 10 minutes after spinal anesthesia till the end of the surgery)
  • intraoperative heart rate beat per minute(every 10 minutes after spinal anesthesia till the end of the surgery.)
  • Duration of sensory block.(3, 6, 12, 24 hours postoperative)
  • postoperative hypotension mmHg(at 1, 3, 6, 12 hours postoperative)
  • Duration of motor block.(3, 6, 12, 24 hours postoperative)
  • Total distance patient will be able to ambulate on first postoperative day(on first postoperative day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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