Comparison of Bupivacaine Peritoneal Infiltration and Intramuscular Diclofenac Versus Bupivacaine Peritoneal Infiltration Alone for Postoperative Pain Relief in Gynecologic Cancer Patients Undergoing Open Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Post-operative pain relief
研究概览
简要总结
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS).
详细描述
The primary objective is to compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score (VAS). The secondary objective is to evaluate the time to first dose and the total amount of morphine requirement after the operation in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •gynecologic cancer patients ,i.e. cervical cancer, endometrial cancer, or ovarian tumor suspicious for malignancy
- •who has scheduled for operation via laparotomy route
- •Women who has ASA physical status I-II
- •All of the have age more than 20 years old
- •able to communicate in Thai
- •Women who agrees to participate in this study
排除标准
- •patient who had emergency conditions - indication for emergency operation
- •intraoperative cardiac arrhythmia
- •operation purpose for only tumor biopsy
- •Women who have abnormal kidney function test (Cr > 1.5)
- •Women with history of gastrointestinal bleeding
- •Women who take the antiplatelet or anticoagulant medications
- •Women with history of allergy to bupivacaine and NSAIDs
- •Women who cannot evaluated pain score
研究组 & 干预措施
bupivacaine only group
Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum, divided in 10 sites before closure and a 3 mL of sterile water was intramuscularly injected immediately after complete the procedure.
干预措施: Diclofenac (Other)
diclofenac and bupivacaine group
Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
干预措施: Diclofenac (Other)
结局指标
主要结局
Post-operative pain relief
时间窗: During acute post operation peroid as 24 hours post operation
compare the postoperative pain between Bupivacaine peritoneal Infiltration plus immediately postoperative intramuscular Diclofenac and Bupivacaine peritoneal infiltration alone by using visual analogue score(VAS). Score 0-10 .When Score is higher than 5 score ,the pateint will gain the analgesia as opioid.
次要结局
- Morphine requirement(During acute post operation period as 24 hours post operation)