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临床试验/NCT06242587
NCT06242587进行中(未招募)不适用

Comparison of Coccygeal Block and Impar Block for the Treatment of Coccydynia

Diskapi Teaching and Research Hospital2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2023年11月2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
32
试验地点
2
主要终点
Visual analogue scale

研究概览

简要总结

The aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. The investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. The investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.

详细描述

Patients with coccygeal pain will be evaluated. Patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. Seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. Patients will be randomised by computer programme. Half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. Pericoccygeal nerve block is performed with the patients lying in the prone position. The sacral horns are visualised using a linear probe. The coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. Impar sympathetic ganglion blockade It is performed in the operating theatre with the patient in the prone position. The sacrum and coccyx are visualised with a lateral view. A needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. Patients will be evaluated before, 1 and 3 months after the procedure by filling out the Visual analogue scale and PARIS functional coxidynia questionnaire. The investigator who evaluates the patients and collects the data after the procedure will be blinded.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Coccygeal pain

排除标准

  • Malignite
  • Infection
  • Pregnancy

研究组 & 干预措施

Group Pericoccygeal block

Active Comparator

Patients undergoing pericoccygeal block

干预措施: Pericoccygeal nerve block (Device)

Group Impar ganglion block

Active Comparator

Patients undergoing impar ganglion block

干预措施: Impar ganglion block (Procedure)

结局指标

主要结局

Visual analogue scale

时间窗: Before treatment, week 4 and week 12

A Visual Analogue Scale (VAS) is the pain rating scales. Numbers 0-10 represent the severity of the patients' pain. No pain : 0, Most severe pain : 10

次要结局

  • PARIS coccidini scale(Before treatment, week 4 and week 12)

研究者

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

Damla Yürük

medical doctor

Diskapi Teaching and Research Hospital

研究点 (2)

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