Efficacy of the Analgesic Effect of Local Anesthetic Injection on Postoperative Pain in Gynecological Laparoscopic Surgeries: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Postoperative Pain score assessed using the Visual Analog Scale .
研究概览
简要总结
This is a randomized, double-blind, controlled clinical trial evaluating the efficacy of local anesthetic (LA) in reducing postoperative pain in patients undergoing gynecologic laparoscopic surgery. Ninety participants will be randomly assigned into three equal groups: Group A will receive LA injection at the port site, Group B will receive intraperitoneal LA injection, and Group C will serve as the control group with no LA intervention. Postoperative pain will be assessed and compared among the three 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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 18 to 60 years
- •Scheduled for elective gynecological laparoscopic procedures, including:
- •Evaluation for primary or secondary infertility
- •Assessment of suspected uterine pathology
- •Evaluation of Müllerian anomalies
- •Assessment of suspected tubal or peritoneal pathology requiring diagnostic exploration.
排除标准
- •Known allergy or hypersensitivity to local anesthetics (e.g., lidocaine or bupivacaine)
- •Body Mass Index (BMI) ≥ 35 kg/m²
- •Severe hepatic or renal impairment
- •Chronic pain conditions requiring regular opioid use
- •History of major abdominal surgery
- •Refusal to provide informed consent or to enroll in the study
研究组 & 干预措施
Port Site Local Anesthetic Injection (Group A)
Participants receive a local anesthetic injection at the trocar/port sites of laparoscopic gynecologic surgery.
干预措施: Bupivacaine 0.25% (Drug)
Intraperitoneal Local Anesthetic Injection (Group B)
Participants receive an intraperitoneal local anesthetic injection before removal of the laparoscopic instruments.
干预措施: Bupivacaine 0.25% (Drug)
结局指标
主要结局
Postoperative Pain score assessed using the Visual Analog Scale .
时间窗: 24 hours after surgery
Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.
Time to First Analgesic Request
时间窗: 24 hours after surgery
次要结局
- Total Analgesic Consumption(within 24 hours after surgery)
- Patient Satisfaction Score(24 hours postoperatively)
- Length of Hospital Stay(From end of surgery until hospital discharge assessed up to 7 days)
- Time to First Patient Ambulation(Within 24 hours after surgery)
研究者
Usama Ahmed Elsaeed Salem, MD
Usama Ahmed Elsaeed Salem, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Cairo University.
Cairo University