The Impact of Saline Temperature and Local Anesthetic Adjuvants on Postoperative Shoulder Pain and Inflammatory Marker Levels Following Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Postoperative Shoulder Pain Intensity: VAS scores recorded at 6, 24, 48, and 72 hours postoperatively.
研究概览
简要总结
Laparoscopic cholecystectomy has become the gold standard for the operative treatment of gallbladder disease due to its minimally invasive nature and improved patient outcomes. However, postoperative pain remains a significant concern following this procedure, affecting patient comfort, recovery, potential for same day discharge and overall satisfaction. However, visceral pain, port-site pain, and referred shoulder pain are occasionally reported in laparoscopic cholecystectomy patients . Postoperative shoulder pain is a common complication following laparoscopic cholecystectomy, often attributed to diaphragmatic irritation.
详细描述
This study will be a randomized, double-blind, controlled trial with a factorial design, consisting of six groups based on saline temperature and the presence of local anesthetic adjuvants:
Group A1: Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic.
Group A2: Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight).
Group B1: Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic. Group B2: Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine).
Group C1: No saline irrigation. Group C2: No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Adults aged 18-65 years.
- •Scheduled for elective laparoscopic cholecystectomy
- •Informed consent obtained.
排除标准
- •1 - Allergies to anesthetics or saline. 2-Previous shoulder surgery. 3-Significant comorbidities (e.g., chronic pain syndromes, autoimmune diseases). 4-Pregnancy or lactation.
- •5-Current use of anti-inflammatory medications or steroids
研究组 & 干预措施
Room-temperature saline without local anesthetic.
Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic.
干预措施: Room-temperature saline (25-30 ml/kg ) irrigation without local anesthetic. (Other)
Room-temperature saline with local anesthetic bupivacaine
Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight).
干预措施: Room-temperature saline (25-30 ml/kg l) with local anesthetic ( 0.25% bupivacaine according to body weight). (Other)
Warm saline irrigation without local anesthetic.
Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic.
干预措施: Warm saline (37°C, 25-30 ml/kg ) irrigation without local anesthetic. (Other)
Warm saline with local anesthetic
Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine).
干预措施: Warm saline (37°C, 25-30 ml/kg) with local anesthetic (0.25% bupivacaine). (Other)
No saline irrigation.
No saline irrigation.
干预措施: No saline irrigation. (Other)
No saline irrigation but with local anesthetic
No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites).
干预措施: No saline irrigation but with local anesthetic (local anesthetic instillation at trocar sites). (Other)
结局指标
主要结局
Postoperative Shoulder Pain Intensity: VAS scores recorded at 6, 24, 48, and 72 hours postoperatively.
时间窗: 6, 24, 48, and 72 hours postoperatively.
Postoperative Shoulder Pain Intensity: VAS scores recorded at 6, 24, 48, and 72 hours postoperatively.
次要结局
未报告次要终点