Role of Ropivacaine Postincisional Infiltration With Intraperitoneal Instillation Analgesia in Postoperative Pain Relief in Patients Undergoing Non Descent Vaginal Hysterectomy: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
Following a hysterectomy, women tend to experience high levels of pain, and many require strong pain killers after the procedure. Ropivacaine is a local anaesthetic drug (injectable numbing medication) which works by blocking pain signals. The aim of this study is to find out whether injections of ropivacaine during surgery can help provide effective pain relief after surgery.Women aged between 45 and 70 who are having a vaginal hysterectomy can participate in the trial. Participants are randomly allocated to one of two groups. Those in the first group are given injections of ropivacaine at the site of the wound and in the peritoneum (space in the body that holds the organs in the abdomen) and those in the second group are given injections of a saline fluid in the same places that offers no pain relief before the end of their surgery. Participants in both groups are then regularly asked to rate their pain levels up to 24 hours after surgery. In addition, the pain killers they receive and length of hospital stay are recorded. There is a chance that the participants who receive the ropivacaine will benefit from lower pain levels after surgery. There are no notable risks of participating.
详细描述
At end of the vaginal hysterectomy operation, the gynecologist will inject the uterosacral, cardinal ligaments, adnexal areas and the vaginal edge with 15 ml of either the ropivacaine solution or the placebo fluid in each side, then 20 ml will be instilled inside the peritoneum. Analgesia will be given on request after operation. Visual analogue score of 0 to 100 mm will be used to assess the degree of pain, with 0 indicating no pain and 100 indicating worst pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •45 to 70 years old
- •Scheduled for NDVH (non descent vaginal hysterectomy) for benign indications without need for oophorectomy or vaginal reconstructive surgery
排除标准
- •Patient weight less than 50 kg
- •Allergy to amide local anesthetic
- •Dementia or mental retardation to a degree which would interfere with data collection
- •Contraindication to non descent vaginal hysterectomy
研究组 & 干预措施
intervention group
Participants are given ropivacaine (0.5%) at a total dose of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation as pre-emptive analgesia.
干预措施: Ropivacaine (Drug)
control group
Participants are given a placebo in the form of fluid injection of saline (0.9%) at total of 50 ml, 30 ml of which is injected locally and 20 ml into the peritoneum once before the end of operation
干预措施: Placebo (Drug)
结局指标
主要结局
pain score
时间窗: At 2 hours post--operatively.
Pain is measured by the patient using the visual analogue score
次要结局
- Time in hours to get out of bed after operation(at 12 hours post--operatively)
- Hospital stay in days(Up to 4 weeks post-operatively)
- Total Narcotic dose (Nalbuphine)(Up to 24 hours post--operatively)
- Total parenteral NSAID (diclofenac sodium) used in the first 24 hours after surgery(at 24 hours post-operatively)
- Proportion of patients with nausea and vomiting in the first 24 hours(At 24 hours post--operatively)
- Time spent in the post-anesthesia care unit(Up to 24 hours post--operatively)
研究者
Eman Omran
Principal investigator
Cairo University