Effect of Low-dose Pregabalin Retard (82.5 mg) Versus Standard-dose Pregabalin Retard (165 mg) on Postoperative Pain and Opioid Consumption After Elective Laparoscopic Abdominal Surgery: a Randomized, Double-blind, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours
研究概览
简要总结
The goal of this clinical trial is to detect whether pregabalin retard (82.5 mg or 165 mg) improves analgesia after elective laparoscopic abdominal surgery in adults. It will also evaluate the safety of both doses.
The main questions it aims to answer are:
Does the higher dose (165 mg) reduce the total amount of opioids needed in the first 24 hours after surgery compared to the lower dose (82.5 mg)? Do the pain scores differ between the two doses? Are there differences in side effects between the two doses?
Researchers will compare two different doses of pregabalin retard to determine which provides better pain control with fewer side effects.
Participants will:
Take one dose of pregabalin retard (82.5 mg or 165 mg) before surgery Receive standard anesthesia and multimodal pain treatment Have their pain levels and opioid use monitored for 24 hours after surgery Be assessed for side effects such as dizziness, nausea, or sedation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •ASA physical status I-III
- •Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)
- •Ability to understand the NRS pain scale and the study procedures
- •Written informed consent obtained
排除标准
- •Known allergy or intolerance to pregabalin, gabapentinoids, or study medications
- •Chronic opioid use (daily use >30 mg oral morphine equivalent for >2 weeks preoperatively)
- •Regular use of gabapentin or pregabalin within 30 days
- •Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or on dialysis
- •Severe hepatic impairment (Child-Pugh C)
- •Uncontrolled epilepsy or other major neurological disorder
- •Severe psychiatric disease, alcohol or substance abuse
- •Pregnancy or breastfeeding
- •Planned postoperative ICU admission for reasons other than routine overnight monitoring
- •Conversion to open abdominal surgery (these patients will be analyzed in sensitivity or excluded, predefined in analysis plan)
研究组 & 干预措施
Group I (Low dose)
Participants of this Arm will take pregabalin retard 82.5 mg orally with a sip of water, 1-2 hours before induction of anesthesia.
干预措施: Pregabalin retard 82.5 mg (Drug)
Group II (High dose)
Participants of this Arm will take pregabalin retard 165 mg orally with a sip of water, 1-2 hours before induct
干预措施: Pregabalin retard 165 mg (Drug)
结局指标
主要结局
Cumulative opioid consumption (IV morphine equivalents) during the first 24 postoperative hours
时间窗: 24 hours
次要结局
- Postoperative pain intensity(2-24 hours postoperative)
研究者
Muhammad Gamal Thabet Ahmed
Lecturer of anesthesia, intensive care medicine and pain therapy
South Egypt Cancer Institute