Application of Dynamic Pain Assessment and Management System in Perioperative Period of Patients With Incarcerated Mixed Hemorrhoids: A Single-Center, Prospective, Open-Label, Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain Numerical Rating Scale (NRS)
研究概览
简要总结
This study aims to investigate whether the dynamic pain assessment and management system can alleviate postoperative pain in patients with incarcerated mixed hemorrhoids and reduce the incidence of complications. A total of 64 eligible patients were enrolled and randomly divided into two groups, with the specific grouping and intervention methods as follows:
① Control Group: Routine drug analgesia and conventional nursing education were adopted.
② Study Group: Patients were managed with the dynamic pain assessment and management system, which included preoperative administration of analgesic drugs, postoperative traditional Chinese medicine (TCM) fumigation, wrist-ankle acupuncture for pain relief, and personalized nursing education.
The study evaluated the effect of the dynamic pain assessment and management system on postoperative analgesia by comparing the Numerical Rating Scale (NRS) scores for pain, recording the Visual Analogue Scale (VAS) scores for quality of life, and analyzing the incidence of complications among patients in different groups. The primary hypothesis of the study is that, compared with routine pain management methods, the dynamic pain assessment and management system can significantly reduce postoperative pain in patients, improve their quality of life, and decrease the incidence of complications (such as bleeding and urinary retention).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- 否
入选标准
- •Aged between 18 and 75 years old
- •Diagnosed with grade III-IV incarcerated mixed hemorrhoids according to the Goligher classification
- •Undergoing standard hemorrhoidectomy
- •Receiving simple intraspinal anesthesia
排除标准
- •Pregnant or lactating patients
- •Patients receiving immunotherapy or with coagulation dysfunction
- •Patients who need to use various analgesic drugs daily
- •Complicated with other anorectal diseases (such as perianal abscess, anal fistula, anal incontinence)
- •Complicated with other systemic diseases (cardiac insufficiency; hepatic or renal insufficiency; diabetes mellitus; coagulation disorders; peptic ulcer, etc.)
- •Incomplete perioperative clinical data
- •Unable to cooperate with follow-up
研究组 & 干预措施
control group
adopted routine drug analgesia
干预措施: Routine drug analgesia (Drug)
study group
Adoption of a Dynamic Pain Assessment and Management System
干预措施: Dynamic Pain Assessment and Management System (Other)
结局指标
主要结局
Pain Numerical Rating Scale (NRS)
时间窗: Baseline, Day 1, 3, 5, 7, and Day 14±2
The NRS uses a linear numerical range of "0 to 10" to represent pain intensity. Patients select the corresponding number based on their own perception, where a score of 0 indicates no pain at all, and a score of 10 represents the most severe pain you can imagine.
次要结局
- Incidence Rate of Complications(within 30 days after surgery)
- Length of Hospital Stay(from the end of surgery to discharge (a maximum of 7 days))