Surgical Wound Infiltration With Sodium Diclofenac Versus Bupivacaine in the Treatment of Acute Postoperative Pain Following Appendectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 主要终点
- rest and dynamic postoperative pain with visual analogue scale
研究概览
简要总结
The infiltration of the surgical wound is an effective strategy for postoperative analgesia. Nonsteroidal antiinflammatories are useful in this way.
Objective: To compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies.
Method: Comparative, double blind, American Society Anesthesiologist classification I-II,18-65años. Group 1 (Bupivacaine n = 14), Group 2 (Diclofenac Sodium n = 14), Group 3 (Bupivacaine + Diclofenac Sodium n = 15). Pain at rest and dynamic, rescue analgesic consumption in Post Anesthesia Care Unit (PACU) and 24 hours after surgery were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society Anesthesiologist I- II
- •aged 18 and 65
- •both sexes
- •patients diagnosed with acute appendicitis operated under general anesthesia
排除标准
- •Patients known to any allergy of the drugs used in the study
- •Different incision approach Mc Burney
- •Some intraoperative surgical complications
- •Pregnant patients
研究组 & 干预措施
Bupivacaine
A dilution of Bupivacaine 0,25% , 15 ml was infiltrated in surgical wound after close the aponeurosis
干预措施: Bupivacaine (Drug)
Bupivacaine, sodium diclofenac
A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis
干预措施: Bupivacaine (Drug)
Bupivacaine, sodium diclofenac
A dilution of Bupivacaine 0,25% and sodium diclofenac 75 mgr, was infiltrated in surgical wound after close the aponeurosis
干预措施: Sodium diclofenac (Drug)
Sodium diclofenac
A dilution of sodium diclofenac 75 mgrs (3ml) and 12 ml of solution 0,9% was infiltrated in surgical wound after close the aponeurosis
干预措施: Sodium diclofenac (Drug)
结局指标
主要结局
rest and dynamic postoperative pain with visual analogue scale
时间窗: 24 hours of postoperative period
appearance of bowel sounds
时间窗: 24 hours of postoperative period
auscultation of bowel sounds
changes in rest and dynamic postoperative pain with visual analogue scale
时间窗: 24 hours of postoperative pain
rescue analgesic consumption
时间窗: 24 hours of postoperative period
次要结局
- number of participants with skin suture removal after 10 days(10 days of postoperative pain)
研究者
Beatriz Arismendi Gómez
Medical Doctor
Hospital Central Dr. Luis Ortega