Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery
Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial
研究概览
详细说明
Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera.
Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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Bangkok、泰国、10400
- Waetasleem Chema
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient who undergoing gynecologic laparoscopic surgery
- Patient who agrees to participate in this study
- Patient able to speak and understand Thai
- Patient able to complete the questionnaire
Exclusion Criteria:
- Patient with history of allergy in any kind anesthetic drug
- Patient who pregnant
- Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery
- Patient whom the surgery is withhold or canceled
- Patient whom the surgery is converted to laparotomy
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：阶乘赋值
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：placebo group
0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and prior skin closure Drug: 0.9%Nacl Other Name: NSS
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0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
其他名称：
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实验性的：Preincision Bupivacaine
0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin closure Drug: 0.5% bupivacaine 10 ml (50 mg) Other Name: Marcaine 0.9%Nacl (Placebo) 10 ml Other Name: NSS
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0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
其他名称：
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实验性的：Preclosure bupivacaine
0.9%Nacl (Placebo) 10 ml were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine
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0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
其他名称：
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实验性的：Bupivacaine group
0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin incision and 0.5% bupivacaine 10 ml (50 mg) were port site infiltration prior skin closure Other Name: Marcaine
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0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Postoperative pain after surgery
大体时间：24-48 hours after surgery
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Postoperative pain score in intervention and placebo groups
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24-48 hours after surgery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Among of pethidine use
大体时间：within 48 hours
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Among of pethidine use to reduced postoperative pain
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within 48 hours
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Duration of hospital stay
大体时间：within 7 days
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Duration of hospital stay after surgery
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within 7 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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