The Influence of the Menstrual Cycle on Acute and Persistent Pain After Laparoscopic Cholecystectomy
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale
研究概览
简要总结
Fluctuations of female sex hormones during the menstrual cycle influence pain perception. Endogenous pain is pronounced in the follicular phase of the menstrual cycle. The investigators tested the primary hypothesis that the women having surgery during their follicular phase have more acute pain and require more opioids than those in the luteal phase, and secondarily the investigators tested that women who have surgery during their follicular phase have more incisional pain at 3 month postoperatively.
详细描述
127 adult females having laparoscopic cholecystectomy were randomized to have surgery during the luteal or follicular phase of their menstrual cycle. Standardized anesthesia and pain management regimen was given to all patients. Pain and analgesic consumption were evaluated in PACU and every four hours in first 24 hours. Adverse effects were also questioned every four hours. Time to oral intake and ambulation were recorded. Post-surgical pain, hospital anxiety and depression scale, and SF-12 questionnaire were also evaluated at 1- and 3-month visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a negative urine pregnancy test
排除标准
- •Patients with pre-existing pain syndromes
- •Patients using routinely using opioids
- •Patients using hormone preparations in the last 6 months
- •Patients with hysterectomy
- •Patients breastfeeding in the previous 6 months
- •Patients with body mass index >35 kg/m2
结局指标
主要结局
Persistent surgical pain after laparoscopic cholecystectomy assessed by VAS scale
时间窗: 3 months
次要结局
- The anxiety and depression was evaluated with Hospital anxiety and depression scale.(3 months)
研究者
SINEM SARI
MD, Assistant Professor
Aydin Adnan Menderes University