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临床试验/NCT07382297
NCT07382297招募中不适用

Analgesic Efficacy of Adding Ultra Sound Guided IPACK Block to Adductor Canal Block for Postoperative Pain Management After Excision of Tumors Around Knee: a Randomized Controlled Trial

National Cancer Institute, Egypt1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年8月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
1
主要终点
Time to the 1st rescue analgesia

研究概览

简要总结

the aim of this study is to determine the analgesic effect of iPACK in combination to ACB after the excision of tumors around the Knee regarding the following:

  • Time to the 1st rescue analgesia.
  • Postoperative morphine consumption.
  • Postoperative visual analogue scale (VAS). This study will include patients, aged 18 to 65 years, belonging to the American Society of Anesthesiologists (ASA) physical status II to IV , undergoing excision of tumors around the knee under spinal anesthesia.

Patients will be randomly allocated Group iPACK plus Adductor canal block (ACB) : patients will receive ACB plus iPACK block.

• Control group : patients will not receive any block but will take morphine 3mg bolus at VAS more than 4 and regular NSAIDS and paracetamol iv.

详细描述

Immediate alleviation of postoperative pain after knee surgeries is critical for patients' postoperative recovery. Ineffective pain management may result in an extended hospital stay and rehabilitation period, as well as the development of chronic pain Non-opioid analgesics are insufficient to alleviate the pain that is intended to be relieved.

Although using Opioids have concerns regarding their potential side effects, which encompass nausea, vomiting, respiratory depression, and addiction Multimodal analgesia, which may include preemptive analgesia, neuraxial blockade, peripheral nerve block, and narcotic and non-narcotic analgesics, is an optimal approach for the management of acute pain following knee surgeries Adductor canal block (ACB) is an interfascial plane infiltration of local anesthetic used to block a portion of the saphenous nerve, which originates in the adductor canal, as well as the obturator nerve ACB combined with an iPACK block results in significantly better postoperative visual analog scale (VAS) scores, knee ranges of motion, as well as ambulation distances compared with ACB alone

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • American Society of Anesthesiologists (ASA) physical status II-IV.
  • Patients undergoing excision of tumors around the knee under spinal anesthesia

排除标准

  • Patient refusal.
  • Neuromuscular disorders
  • Allergy to local anesthetics
  • Previous history of knee surgery
  • Patients with a prior knee infection
  • Contraindications to spinal anesthesia as coagulopathies and severe aortic stenosis.

研究组 & 干预措施

adductor canal block with iPACK

Active Comparator

The adductor canal will be identified. a spinal needle 22 gauge x 3.5 inches will be advanced with the guidance of ultrasound in an in-plane technique, and 15ml of 0.5% bupivacaine will be injected then IPACK block will be performed The probe will be applied to the popliteal fossa for identification of the popliteal artery and femur. Then, the probe will be slid distally for revealing the two femoral condyles followed by proximal sliding of the probe until the humps of the femoral condyles disappeared and the flat metaphysis appeared. a spinal needle 22G x 3.5 inches will be advanced from the lateral aspect and directed across the space between the popliteal artery and femur and once the needle reaches the medial edge of the femur, nearly at the level of the popliteal artery, negative aspiration will be confirmed and 15ml of 0.5% bupivacaine will be injected incrementally as the needle will be withdrawn.

干预措施: adductor canal block with iPACK (Procedure)

control group

Other

visualizing the adductor canal without doing any block for the control group

干预措施: control group (Other)

结局指标

主要结局

Time to the 1st rescue analgesia

时间窗: 24 hours postoperative

Time to the 1st rescue analgesia

次要结局

  • Total morphine consumption(first 24 hour)
  • pain score ( visual analogue scale)(at 2 hours ,4 hours,6 hours, 12 hours,18 hours and 24 h postoperatively)

研究者

发起方
National Cancer Institute, Egypt
申办方类型
Other
责任方
Sponsor

研究点 (1)

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