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临床试验/NCT06096584
NCT06096584尚未招募4 期

TIPS Block vs Dual Subsartorial Block for Total Knee Arthrolplasty: Double Blinded Randomized Controlled Study

Alexandria University2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2023年12月最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
入组人数
88
试验地点
2
主要终点
Postoperative resting visual analogue scale score.It's a 0-10 score where 0 is no pain and 10 is the worst pain

研究概览

简要总结

The present study examines adding local anesthetic injection superior to the sartorius at the level of the femoral triangle to block the intermediate femoral cutaneous nerve (IFCN) which is responsible for the innervation of the anterior thigh and the proximal part of the parapatellar incision used for total knee arthroplasty (TKA). This may provide superior analgesia when added to dual subsartorial blockade in cases of total knee arthroplasty

详细描述

Introduction: Maximum pain control with regional analgesic techniques after total knee arthroplasty (TKA) is crucial for early rehabilitation after surgery. The ideal regional anesthetic technique should cover all the essential innervations of the knee joint involved in each surgical step without causing motor blockade.

The investigators hypothesize that local anesthetic injection superior to the sartorius at the level of the femoral triangle may block the intermediate femoral cutaneous nerve (IFCN) which is responsible for the innervation of the anterior thigh and the proximal part of the parapatellar incision used for TKA and provide superior analgesia when added to dual subsartorial blockade in cases of TKA.

Patients will be divided into 2 groups. Group TIPS; patients will receive double level subsartorial block and suprasartorial LA injection at the level of the distal FT after induction of general anesthesia (GA). Group Dual; patients will receive double level subsartorial canal block after induction of GA.

Upon arrival to the operating room (OR), a multichannel monitor will be attached to patients, followed by the administration of 2 mg midazolam IV after securing an IV cannula. Induction of anesthesia will be carried out with 2 mic/kg fentanyl, 2 mg/kg propofol and 25 mg atracurium followed by insertion of a proper size laryngeal mask airway (LMA). Patients will be randomly allocated into 2 groups by a computer generated program.

Group Dual: Patients will receive a combination of femoral triangle block and distal ACB. Femoral triangle block will be given just 1-2 cm proximal to the apex of the femoral tringle which is the point at which the medial border of the sartorius muscle (STM) meets the medial border of the adductor longus muscle (ALM). Ten ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected just below the STM. Another 20 ml of 0.25 % bupivacaine mixed with 2 mg dexamethasone will be injected in the lower one-third of the adductor canal. At this level, femoral vessels dip into the opening of the adductor hiatus to become popliteal vessels. Sonoanatomy of this region shows the adductor magnus muscle (AMM) posteromedially, vastus medialis muscle (VMM) anterolaterally, and the STM medially.

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
Double (Participant, Outcomes Assessor)

盲法说明

Double blinded

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for unilateral total knee arthroplasty

排除标准

  • BMI > 35 kg/m2
  • Pre-existing neurological deficit
  • Any disability of the non-operated limb preventing fair mobilization
  • Infection at the site of injection
  • Chronic opioid users/abusers

结局指标

主要结局

Postoperative resting visual analogue scale score.It's a 0-10 score where 0 is no pain and 10 is the worst pain

时间窗: 1st 24 hours after surgery

Resting visual analogue scale score assessment will be carried out every 4 hours during the 24 hour follow up period

次要结局

  • Total postoperative morphine requirements(1st 24 hours after surgery)
  • Postoperative dynamic visual analogue scale score. It's a 0-10 score where 0 is no pain and 10 is the worst pain(1st 24 hours after surgery)
  • Postoperative functional outcome(1st 24 hours after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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