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临床试验/NCT05956275
NCT05956275已完成4 期

Comparison Between USG-Guided Infiltration Popliteal Artery Capsule Knee Block Versus Adductor Canal Block Application as Postoperative Analgesia in Total Knee Prosthesis Under General Anesthesia: Randomized Clinical Trial

Siirt Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年12月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
tramadol consumption

研究概览

简要总结

The purpose was to evaluate the effect of USG-guided adductor canal block and infiltration popliteal artery capsule knee block combination on postoperative analgesia before total knee arthroplasty.

详细描述

In the present study, the purpose was to evaluate the effect of Ultrasound(USG)-guided adductor canal block(ACB) and infiltration popliteal artery capsule knee block(IPACK) combination on postoperative analgesia before total knee arthroplasty(TKA). A total of 40 patients,who were aged 18-75 with the American Society of Anesthesiologists score(ASA) I-III physical status,and who were scheduled for TKA under general anesthesia,were included in the present study.ACB and IPACK were performed in group A(ACB+IPACK) accompanied by USG, Bupivacaine and 10 mL of 0.9% sodium chloride were applied in each block application.No block was applied to the patients in group B.Patient-controlled analgesia was administered to both groups 30 minutes before the end of the surgery.Tramadol HCL was infused at a concentration of 4mg/ml.A bolus of 20 mg of tramadol hydrochloride was given with a lock-in interval of 30 minutes.Postoperative systolic arterial pressure(SAP),diastolic arterial pressure(DAP),mean arterial pressure(MAP),heart rate(HR),visual analog scale(VAS),analgesic consumption,nausea,vomiting, and patient satisfaction scores were recorded.

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 (Participant, Care Provider, Investigator)

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

  • aged between 18-75 years
  • who were scheduled for elective total knee arthroplasty in Bolu Abant Izzet Baysal University Training and Research Hospital Orthopaedics and Traumatology Clinics

排除标准

  • Patients with hypersensitivity to the drugs to be used in the study or the substances in their composition
  • pregnant women
  • severe cardiac, pulmonary, hepatic, and renal disease
  • a history of chronic opioid use and chronic pain syndrome
  • patients who were not suitable for regional anesthesia (bleeding diathesis, infection in the procedure area), and those who could not apply patient controlled anesthesia

研究组 & 干预措施

adductor canal block and infiltration popliteal artery capsule knee block

Active Comparator

Adductor canal block and infiltration popliteal artery capsule knee block were performed accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application.

干预措施: Tramadol (Drug)

adductor canal block and infiltration popliteal artery capsule knee block

Active Comparator

Adductor canal block and infiltration popliteal artery capsule knee block were performed accompanied by USG, Bupivacaine and 10 mL of 0.9% NaCl were applied in each block application.

干预措施: Morfin (Drug)

Control

Sham Comparator

No block performed

干预措施: Tramadol (Drug)

Control

Sham Comparator

No block performed

干预措施: Morfin (Drug)

结局指标

主要结局

tramadol consumption

时间窗: 24 hours

tramadol consumption amounts were 0-1 hours, 1-12 hours, 12-24 hours

using morphine as rescue analgesia

时间窗: 24 hours

rescue analgesia was evaluated for 0-1 hour, 1-12 hours, and 12-24, the number of patients who used morphine

次要结局

未报告次要终点

研究者

发起方
Siirt Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

asım erçelik

Spesialist Doctor

Siirt Training and Research Hospital

研究点 (1)

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