Effect Of Specimen Extraction Site And Local Anesthesia On Postoperative Pain In Laparoscopic Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Postoperative Pain Score at the Specimen Extraction Site
研究概览
简要总结
The aim of this prospective, randomized study is to evaluate the effects of two different specimen extraction sites (periumbilical versus left lower quadrant) and the routine application of port-site local anesthesia infiltration on postoperative pain and complications in patients undergoing laparoscopic appendectomy for acute appendicitis."
详细描述
The purpose of this prospective, randomized clinical trial is to investigate the clinical impact of two different specimen extraction sites (periumbilical versus left lower quadrant) on postoperative pain. Additionally, the study evaluates the efficacy of routine preemptive local anesthesia infiltration at all trocar sites. Patients undergoing laparoscopic appendectomy are randomly allocated into four parallel groups based on the extraction site and the administration of local anesthesia. The primary objective is to compare local and regional pain scores at the extraction and non-extraction port sites, assessed via the Numeric Rating Scale (NRS) at the 2nd, 4th, 8th, 12th, and 24th postoperative hours. Secondary outcomes include total postoperative analgesic consumption, operative duration, length of hospital stay."
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older
- •Diagnosed with acute appendicitis
- •Scheduled for emergency laparoscopic appendectomy
- •Informed consent obtained
排除标准
- •Conversion to open surgery
- •Known allergy to local anesthetics
- •Cognitive impairment or inability to understand the NRS scoring system
- •Pregnancy
研究组 & 干预措施
Left Lower Quadrant Extraction - Local Anesthesia
Specimen is extracted from the left lower quadrant port. Local anesthesia infiltration is applied to all port sites.
干预措施: Port-site local anesthesia infiltration (Drug)
Periumbilical Extraction - Local Anesthesia
Specimen is extracted from the periumblical port. Local anesthesia infiltration is applied to all port sites.
干预措施: Port-site local anesthesia infiltration (Drug)
Left Lower Quadrant Extraction - No Local Anesthesia
Specimen is extracted from the left lower quadrant port. No local anesthesia is infiltrated to the port sites
干预措施: Port-Site Saline Infiltration (Placebo) (Other)
Periumbilical Extraction - No Local Anesthesia
Specimen is extracted from the periumblical port. No local anesthesia is infiltrated to the port sites
干预措施: Port-Site Saline Infiltration (Placebo) (Other)
结局指标
主要结局
Postoperative Pain Score at the Specimen Extraction Site
时间窗: Postoperative 8th hour.
Evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain).
次要结局
- Postoperative Pain Scores at Subsequent Time Points(Postoperative 2th, 4th, 12th, and 24th hours.)
- Total Postoperative Analgesic Consumption(Postoperative 24 hours)
- Length of Hospital Stay(From postoperative admission to the general surgery ward until hospital discharge.)
- Operative Duration(From initial skin incision to final wound closure (intraoperatively).)
- Total Intraoperative Insufflation Gas Volume(From initiation of pneumoperitoneum until completion of the surgical procedure.)
研究者
YUNUS YÜKSEL
General Surgery Resident
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital