Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative pain after surgery
研究概览
简要总结
To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Bupivacaine Hydrochloride (Drug)
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
干预措施: Bupivacaine Hydrochloride (Drug)
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
干预措施: Bupivacaine Hydrochloride (Drug)
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
干预措施: Bupivacaine Hydrochloride (Drug)
结局指标
主要结局
Postoperative pain after surgery
时间窗: 24-48 hours after surgery
Postoperative pain score in intervention and placebo groups
次要结局
- Among of pethidine use(within 48 hours)
- Duration of hospital stay(within 7 days)