TAP Block Versus Conventional Systemic Analgesia in Laparoscopic Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 380
- 试验地点
- 2
- 主要终点
- Opioid consumption during the first 48 h postoperatively.
研究概览
简要总结
The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.
Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
详细描述
Laparoscopic cholecystectomy constitutes a routinely performed procedure world-wide. Analgesia accounts for one of the major keys for success especially in enhanced recovery after surgery pathway and ambulatory surgery. Hence, controlling opioid consumption used in conventional systemic analgesia is mandatory while reliving pain. The TAP block is integrated within a multimodal analgesia. It corresponds to a locoregional analgesia.
The goal of this clinical trial is to compare TAP block to conventional systemic analgesia for postoperative pain management in patients undergoing elective laparoscopic cholecystectomy. As the adverse effects of pain management is related to size of opioid dose use, opioid consumption is chosen as the primary outcome and a decrease of at least 20% in the TAP block compared with the conventional systemic analgesia is considered to be clinically significant.
Written informed consent has to obtained from all study patients. This trial is a prospective parallel group randomized superiority trial comparing TAP block to classic systemic analgesia in patients undergoing elective laparoscopic surgery in the department of surgery, Mahmoud El Matri Hospital, Ariana, with a 1:1 allocation ratio.
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
- Single (Participant)
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
- •All patients scheduled for elective laparoscopic cholecystectomy at the department of surgery, Mahmoud El Matri Hospital, Ariana
排除标准
- •Severe renal insufficiency (GFR < 30 ml/min)
- •Severe hepatic insufficiency (TT ≤ 50%)
- •Severe COPD (FEV1 > 30%)
- •Metastatic malignancy
- •Hematologic disease or a congenital clotting disorder
- •Preoperative opioid use
- •Age under 18 years
- •Pregnancy or breast-feeding
- •Hyper-reactivity toward ropivacaine
- •Estimated risk for conversion to open surgery > 50%
结局指标
主要结局
Opioid consumption during the first 48 h postoperatively.
时间窗: Every six hours
Opioids are given only on request based on pain numerical rating scale (pain NRS) varying from 0 to10. For pain NRS \> 3 at rest or for pain NRS \> 5 on exercise, oxycodone is administrated intravenously at the recovery room at the dose of 0.05 mg/kg. Then, it is used intramuscularly at the dose of 0.1 mg/kg up to 24 hours after surgery and orally at the dose of 0.15 mg/kg between 24 and 48 hours after surgery. At 2 to 4 weeks postoperatively, all patients are contacted either by phone or at the outpatient clinic during a follow-up visit and asked to complete a form with questions evaluating pain sensations, pain intensity, need for pain medication, performance of daily activities, and any limitations of these due to postoperative abdominal pain.
次要结局
- Pain intensity on a numerical rating scale (pain NRS, 0-10)(Every six hours)
- Postoperative evaluation at 4 weeks(At 4 weeks after surgery)
研究者
Sana Landolsi
Associate professor in general surgery, University Tunis El Manar, Faculty of medicine of Tunis, Department of surgery, Mahmoud El Matri hospital, Ariana, Tunisia
Ministry of Scientific Research, Tunisia