Procjena Postoperativne Boli Konvencionalnom i Tumescentnom Anestezijom u Laserskom Tretmanu Pilonidalnog Sinusa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pain score VAS - Day 1
研究概览
简要总结
"Assessment of postoperative pain with conventional and tumescent local anesthesia in the laser treatment of pilonidal sinus."
The aim of this study is to:
examine the possible difference in postoperative pain between two local anesthesia procedures after laser treatment of pilonidal sinus disease on the first and second postoperative day, as well as one week after surgery.
During the procedure, two well-established anesthesia techniques are used to make the surgical area painless.
The first is local anesthesia, in which the anesthetic is injected into and under the skin.
The second procedure is tumescent anesthesia. In this procedure, the anesthetic in diluted form is introduced into the subcutaneous tissue. Both procedures are used in surgery and are standard methods of local anesthesia.
详细描述
Title/topic of the research project:
Assessment of postoperative pain under conventional and tumescent local anesthesia in laser treatment of pilonidal sinus
Type of project/research:
Prospective, randomized study
Location of research:
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed pilonidal sinus disease
- •Laser treatment for pilonidal sinus disease
- •Able to provide informed consent
排除标准
- •Recurrent pilonidal sinus
- •Chronic pain syndrome
- •Prisoners
研究组 & 干预措施
Conventional local anesthesia for SiLaC
Local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
干预措施: local anesthesia using 2% lidocaine (Drug)
Conventional local anesthesia for SiLaC
Local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
干预措施: SiLaC (Device)
Conventional local anesthesia for SiLaC
Local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
干预措施: Questionnaire and physical examination (Other)
Tumescent local anesthesia for SiLaC
Tumescent local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
干预措施: SiLaC (Device)
Tumescent local anesthesia for SiLaC
Tumescent local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
干预措施: Questionnaire and physical examination (Other)
Tumescent local anesthesia for SiLaC
Tumescent local anesthesia is administered before laser treatment of pinlonidal sinus disease. Postoperative the pain score is measured using the visual analog scale.
干预措施: Tumescent local anesthesia (Drug)
结局指标
主要结局
Pain score VAS - Day 1
时间窗: 24 to 48 hours after surgery
VAS (visual analog scale for pain) value obtained via questionnaire on day 1 after the operation.The VAS score has a scale of 1-10, where 1 represents completely pain-free and 10 represents the strongest imaginable pain.
次要结局
未报告次要终点
研究者
Gabriela Katharina Pomper
Specialist for plastic, reconstructive and aesthetic surgery
Opća županijska bolnica Požega