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临床试验/NCT06203483
NCT06203483招募中不适用

The Comparison Of Ultrasound Guıded Adductor Canal Block And Perıcapsular Nerve Group Block For Postoperatıve Analgesıa Management Following Knee Arthroplasty Surgery

Bursa City Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年1月20日最近更新:
适应症
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
60
试验地点
1
主要终点
Global recovery scoring system (patient satisfaction scale)

研究概览

简要总结

Knee arthroplasty surgery numbers are increasing depending on joint deformities and cartilage degenerations. Severe postoperative pain may occur in these patients due to surgery and the placed prosthesis.

The aim of study is to compare the effectiveness of AKB and PENG block for postoperative analgesia management after knee arthroplasty.

详细描述

Knee arthroplasty surgery numbers are increasing depending on joint deformities and cartilage degenerations. Severe postoperative pain may occur in these patients due to surgery and the placed prosthesis. Postoperative analgesia is important for early mobilization. So that, early movement of the joint is ensured and complications such as thromboembolism and infection are prevented. Various methods can be used for postoperative analgesia. One of these methods is epidural analgesia. However, it may not be applied due to the patient's refusal or the technical difficulties in the application. Another option is opioid agents. However; opioids have side effects such as nausea, vomiting, sedation, respiratory depression. Femoral nerve blockade can be done, but it is not preferred because it may prevent mobilization as a result of motor blockade.

Current regional anesthesia techniques used in knee surgery include selective blockade of the saphenous nerve in the adductor canal (adductor canal block-ACB) and pericapsular nerve group block (PENG). Adductor canal block; affects the vastus medialis branch of the saphenous nerve, one of the two largest sensory nerves from the femoral nerve to the knee, and the articular branches of the obturator nerve. Since the block is made in the distal thigh, the innervation of the quadriceps muscle is not affected, and therefore the motor power of this muscle is largely preserved. Another lower extremity peripheral regional blockade technique that is gaining importance today is PENG block. PENG, which is a musculofacial plane block made between the tendon of the psoas muscle and the ramus pubis, provides block of the femoral nerve, obturator nerve and accessory obturator nerve. In both block methods, pure sensory blockade provides analgesia without quadriceps muscle weakness, and this provides a significant advantage in terms of early mobilization.

The aim of this study is to compare these two analgesic methods in terms of effectiveness for postoperative analgesia management after knee arthroplasty. The primary outcome is to compare global recovery scores (QoR-15 scale), the secondary outcome is to compare postoperative pain scores (NRS), to evaluate postoperative opioid consumption, postoperative rescue analgesic (opioid) use, presence of motor blockade, postoperative first mobilization time, and side effects (allergic reaction, nausea, vomiting) associated with opioid use in this study.

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

The patient and the outcomes assessor who performs postoperative pain evaluation will not know the group

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • American Society of Anesthesiologists (ASA) classification I-II
  • Scheduled for total knee arthroplasty under spinal anesthesia

排除标准

  • history of bleeding diathesis
  • receiving anticoagulant treatment,
  • known local anesthetics and opioid allergy,
  • infection of the skin at the site of the needle puncture,
  • pregnancy or lactation,
  • patients who do not accept the procedur

研究组 & 干预措施

Adductor canal block

Active Comparator

Adductor canal block will be performed at the end of the surgery. Patients will be administered tenoxicam (Tilcotil 20 mg flakon) 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol (100 mg-Contramal ® ampul) will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine (Aldolan ampul 100 mg/2 ml) IV will be administered.

干预措施: Adductor canal block (Drug)

PENG block

Active Comparator

PENG Block will be performed at the end of the surgery. Patients will be administered tenoxicam (Tilcotil 20 mg flakon) 20 mg IV every 12 hours in the postoperative period. A patient controlled device prepared with 5 mg/ ml tramadol (100 mg-Contramal ® ampul) will be attached to all patients with a protocol included 10 mg bolus without infusion dose, 20 min lockout time and 4 hour limit. If the VAS score will be ≥ 4, 0,5 mg/kg-1 meperidine (Aldolan ampul 100 mg/2 ml) IV will be administered.

干预措施: PENG block (Drug)

结局指标

主要结局

Global recovery scoring system (patient satisfaction scale)

时间窗: The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.

The investigators will use the Turkish version of Quality of Recovery / QoR-15 questionairre PART A How have you been feeling in the last 24 hours? (0 to 10, where: 0 = none of the time \[poor\] and 10 = all of the time \[excellent\]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Have you had any of the following in the last 24 hours? (10 to 0, where: 10 = none of the time \[excellent\] and 0 = all of the time \[poor\]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed

次要结局

  • Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")(Patients will be evaluated at the first 24 hours period postoperatively.)
  • The use of rescue analgesia(Meperidine consumption will be recorded at the first 24 hours period postoperatively.)

研究者

发起方
Bursa City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mursel Ekinci

Assoc Prof

Bursa City Hospital

研究点 (1)

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