The Ideal Local Anesthetic for Intraperitoneal Gallbladder Bed Infiltration Following Laparoscopic Cholecystectomy - 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
- Visual analogue scale - pain score
研究概览
简要总结
To control pain after surgery for removal of gallbladder, local anesthetic agent can be sprayed on the liver bed from where the gallbladder is removed. This study was conducted to identify the ideal local anesthetic agent for this purpose.
详细描述
Laparoscopic cholecystectomy is the gold standard operation for symptomatic cholelithiasis; however, pain remains a major factor increasing morbidity and length of hospital stay. Infiltration of gallbladder bed with local anesthetic has been shown to improve post-operative pain after laparoscopic cholecystectomy, although, it is unclear which local anesthetic provides superior pain relief. Patients undergoing laparoscopic cholecystectomies were randomized into 3 groups of 30 patients each depending on the local anesthetic instilled in the gallbladder bed; lignocaine (Group A), bupivacaine (Group B), or a combination of lignocaine and bupivacaine (Group C). Pain was measured using visual analogue score at 2-, 6-, 12- and 24-hours following surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •elective/emergency laparoscopic cholecystectomy
- •ASA grade I/II
- •Ages 18-75 years
排除标准
- •patients on chronic analgesics
- •pts receiving analgesics 24 hours prior to surgery
- •intraoperative bile spillage or drain placement
- •CBD exploration or T-tube insertion
- •BMI > 40 kg/m2
- •pts allergic to, or otherwise not able to receive medications being tested
研究组 & 干预措施
Lignocaine
patients received 20 ml of 1% lignocaine (Xyloaid-lignocaine HCl injection) infiltrated in the gall bladder bed after removal of the gall bladder, along with 10 ml of 1% lignocaine infiltration at the port sites at the end of the procedure
干预措施: Local Anesthesia (Procedure)
Bupivacaine
Subjects received 20 ml of 0.25% bupivacaine (Bupicain-Bupivacaine HCl injection) infiltration in gall bladder bed, along with 10 ml of 0.25% bupivacaine at port sites
干预措施: Local Anesthesia (Procedure)
Lignocaine + Bupivacaine
patients received 10 ml of 1% lignocaine along with 10 ml of 0.25% bupivacaine infiltrated in gall bladder bed, and then 5 ml of 1% lignocaine along with 5 ml of 0.25% bupivacaine at the port sites
干预措施: Local Anesthesia (Procedure)
结局指标
主要结局
Visual analogue scale - pain score
时间窗: 2-, 6-, 12-, 24-hours following surgery
Visual analogue score to quantify pain following laparoscopic cholecystectomy. Maximum value is 10 (which means worst pain), and minimum value is 0 (which means no pain).
次要结局
- rescue analgesia(within 24 hours following surgery)
- Shoulder tip pain(within 24 hours following surgery)
- Flatus(within 24 hours following surgery)
- nausea/vomiting(within 24 hours following surgery)
- Time to ambulation(within 24 hours following surgery)
- Mean arterial pressure(2-, 6-, 12-, 24-hours following surgery)
- Heart rate(2-, 6-, 12-, 24 hours)
- oxygen saturation(2-, 6-, 12-, 24 hours)
研究者
Syed Moiz Ahmed
Post-graduate resident, Principle Investigator, Department of General Surgery
Pakistan Air Force (PAF) Hospital Islamabad