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临床试验/NCT06728488
NCT06728488进行中(未招募)不适用

Comparison of the Analgesic Efficacy and Duration of Analgesic Effect of PENG Block Application With PENG Block and Pulse Radiofrequency Ablation in Chronic Hip Pain

Kocaeli University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
vNRS Verbal Numerical Rating Scale

研究概览

简要总结

Comparison of the analgesic efficacy and duration of analgesic effect of PENG block application with PENG block and pulse radiofrequency ablation in chronic hip pain.

详细描述

Patients with chronic hip pain will be divided into two groups, and after providing the necessary information, informed consent forms will be obtained for inclusion in the study from both groups. The 'Verbal Numerical Rating Scale (vNRS)' will be assessed before the procedure. Patients to undergo PENG block and PENG block with pulse radiofrequency ablation will be monitored prior to the procedure. After the procedure, they will be monitored for 3 hours under observation. At the third hour after the procedure, before leaving the operating room, and at the 1st and 3rd months, patients will be contacted by phone, and the 'Verbal Numerical Rating Scale (vNRS)' will be evaluated. This will allow the comparison of the effects of PENG block and PENG block with pulse radiofrequency ablation on pain management in chronic hip pain.

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
Single (Participant)

盲法说明

Both surgical groups will be randomly assigned into groups using simple randomization through the -www.randomize.net- application, and a single-blind design will be implemented.

入排标准

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

入选标准

  • •Patients with chronic hip pain Aged 18-80 ASA I-III patients

排除标准

  • •Patients with allergies to the medications used, severe cardiac, renal, pulmonary, liver, and endocrine diseases, patients with uncontrolled blood sugar levels (diabetes mellitus), patients who have used anticoagulant medications in the last five days, patients with bleeding or clotting disorders, those with implanted medical devices such as pacemakers and defibrillators, patients with infections at the procedure site, patients with psychiatric disorders or communication difficulties, patients with missing data, and patients who do not wish to undergo regional block are defined as exclusion criteria.

研究组 & 干预措施

PENG block

Experimental

The patients in the PENG block group will provide their consent. Standard monitoring will be applied. The patients will be positioned supine. After antiseptic procedures, 2 ml of 2% lidocaine will be infiltrated into the needle insertion site. The linear ultrasound probe will be placed in the transverse plane over the AIIS. The position of the ultrasound probe will be verified by visualizing the iliopectineal eminence, iliopsoas muscle and tendon, femoral artery, and pectineus muscle. Using a Stimuplex® A 100 mm 20 gauge needle (Braun Melsungen AG, Melsungen, Germany) with the in-plane technique, the needle will be inserted laterally to medially into the space between the psoas tendon and the pubic ramus. Negative aspiration will be performed to ensure no blood is aspirated, and then 20 ml of 0.25% bupivacaine and 8 mg of dexamethasone will be injected to perform the PENG block. After the procedure, the cannula will be removed, and the insertion site will be cleaned and dressed.

干预措施: PENG Block (Other)

PENG block and pulse radiofrequency ablation

Experimental

After obtaining consent, the patients in the PENG block and pulse radiofrequency ablation group will be brought into the operating room. Standard monitoring will be applied (ECG, SpO2, NIBP). The patients will be positioned supine. After performing the necessary aseptic and antiseptic procedures, 2 ml of 2% lidocaine will be infiltrated into the needle insertion site. The Boston Scientific unified echogenic 10cmx10mmx20G (0.9mm) radiofrequency cannula will be advanced until it makes contact with the superior ramus near the iliopectineal eminence. Pulse radiofrequency ablation will be performed with two cycles of 90 seconds each, and after each cycle, the needle will be moved 2 mm medially. After pulse radiofrequency ablation, 20 ml of 0.25% bupivacaine and 8 mg of dexamethasone will be applied. After the procedure, the cannula will be removed, and the insertion site will be cleaned and dressed.

干预措施: PENG block and pulse radiofrequency ablation (Other)

结局指标

主要结局

vNRS Verbal Numerical Rating Scale

时间窗: 3 months

Verbal Numerical Rating Scale.At the 3rd hour after the procedure, before the patients leave the operating room, and at the 1st and 3rd months, they will be contacted by phone, and the 'Verbal Numerical Rating Scale (vNRS)' will be evaluated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berkay BALCI

Research Assistant Doctor

Kocaeli University

研究点 (1)

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