The Effect of Preemptive Pudendal Nerve Block Using Bupivacaine Versus Ropivacaine on Post-operative Pain After Posterior Vaginal Repair, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 72
- 主要终点
- post operative pain assessment
研究概览
简要总结
To investigate the efficacy of preemptive pudendal nerve blockade on postoperative pain, after posterior vaginal repair, below the level of ischial spine, excluding uterine suspension procedures that are higher than the coverage of the block.
Primary outcome:
The primary outcome measures of the study visual analogue pain scores and postoperative analgesic consumption.
详细描述
Preemptive analgesia is widely used during surgical procedures to reduce post-operative pain. Pudendal nerve blockade has been established and provides highly effective and safe anaesthesia to the vulva, lower vagina, and perineum. Various local anaesthetics used in gynaecological practice, including lidocaine, bupivacaine and mepivacaine. Using Bupivacaine in the Pudendal block has shown controversial results. The use of Ropivacaine as preemptive analgesia in different nerve blocks, including nerve block on the face, thorax, abdominal and perineal region, and had shown to be effective.
Bupivacaine and ropivacaine both are commonly used for peripheral nerve blocks. ropivacaine has been shown in two randomized control trials to improved postoperative analgesia and quicker recovery, compared to placebo [28,29]. Previous studies showed the promising effect on different nerve blocks including nerve block on the face, thorax, abdominal and perineal region. However, there are no studies done to investigate the effect of ropivacaine or in comparing their analgesic duration in the setting of a pudendal nerve block for gynaecological surgeries. Therefore, this study aims to conduct a comparison of the duration of postoperative analgesia achieved by two agents.
Therefore, this study aims to conduct a randomized comparison of the duration of postoperative analgesia achieved by pudendal nerve blockade using ropivacaine compared to bupivacaine, in women undergoing posterior vaginal repair. The primary outcome is pain scores and postoperative analgesic consumption, and secondary outcomes include post-operative recovery, ambulation and measure length of hospital stay.
Hypothesis:
Investigators assume that using the Preemptive pudendal nerve block will reduce the postoperative pain and decrease the postoperative analgesic demand in patients who undergo posterior vaginal repair.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
post operative pain assessment
时间窗: change in pain score from one hour up to 36 hours after surgery will be recorded.
visual analogue scale for will be used for post operative pain assessment from scale 1 to 10. A higher score indicate worse outcome.
postoperative analgesic consumption.
时间窗: from one hour up to 36 hours after surgery will be recorded.
grams or miligrams of intravenous or oral analegesics will be recorded and minimum and maximum amount needed will be recorded. A higher amount indicate worse outcome. An average will be calculated.
次要结局
- Post-operative recovery(up to 6 weeks follow up appointment.)
- Adverse reaction of analgesic(from 1 hour up to 36 hours postoperatively)
- Patient satisfaction(up to 6 weeks postoperative followup)
- Length of hospital stay.(The stay in hospital up to 36 hours to 2 days)
研究者
Munazzah Rafique
Physician
King Fahad Medical City