Effectiveness of TAP Block Versus Intravenous Analgesia in Postoperative Pain Management Following Gynecological Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Postoperative pain intensity (Numeric Rating Scale)
研究概览
简要总结
Optimal postoperative pain control is crucial in laparoscopic gynecologic surgery, particularly within Enhanced Recovery After Surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is a regional anesthesia technique that may reduce opioid consumption and enhance recovery. However, data comparing TAP block directly with standard intravenous analgesia in this surgical context are limited.
详细描述
This prospective, randomized controlled trial included patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery). Patients were randomized into two groups:
- TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron).
- Intravenous Analgesia Group: Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours.
Primary outcome: Postoperative pain intensity (NRS) at 1, 6, and 24 hours. Secondary outcomes included additional analgesic use, side effects, and patient satisfaction.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age > 18 years, scheduled for elective gynecological surgery
排除标准
- •age <18, emergency surgery
研究组 & 干预措施
intravenous analgesia
Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours.
干预措施: TAP Block Group (Drug)
结局指标
主要结局
Postoperative pain intensity (Numeric Rating Scale)
时间窗: 1, 6, 24 hours postoperatively.
Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at 1, 6, and 24 hours postoperatively.
次要结局
- Total Analgesic Consuption.(0-24 hours postoperatively.)
- Incidence of Side Effects.(0-24 hours postoperatively)
- Patient Satisfaction With Analgesia(24 hours postoperatively)
研究者
Michela Rauseo
MD, PhD
University of Foggia