Dexmedetomidine as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Multicentre Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 195
- 试验地点
- 2
- 主要终点
- postoperative 24-hours cumulative morphine consumption
研究概览
简要总结
The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.
详细描述
Laparoscopic cholecystectomy, which is a common surgical procedure, is associated with less postoperative pain in comparison to open cholecystectomy. However, this pain needs to be treated adequately to allow early mobilization.
Ultrasound guided transversus abdominis plane (TAP) block is an established technique to manage post laparoscopic cholecystectomy pain. 1 In addition, the use of TAP blocks reduced the need for intraoperative and postoperative opioids and the side-effects associated with their use.
The aim of a TAP block is to deposit local anaesthetic in the plane between the internal oblique and transversus abdominis muscles targeting the spinal nerves in this plane. The innervation to abdominal skin, muscles and parietal peritoneum will be interrupted.
Dexmedetomidine which is an Alpha 2-adrenergic agonist produces analgesia via a non-opioid mechanism and is also known to enhance central and peripheral neural blockades.2 Dexmedetomidine added to bupivacaine or levobupivacaine for brachial plexus block shortens sensory and motor block onset time, extends motor and sensory block durations, and also extends the postoperative analgesia.3, 4
We postulate that the use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the morphine consumption after laparoscopic cholecystectomy.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •American Society of Anesthesiologists class I and II patients
- •general anaesthesia
排除标准
- •cardiovascular disease
- •respiratory disease
- •neurological disease
- •renal disease
- •hepatic disease
- •hormonal disease
- •pregnancy
- •body mass index > 35 kg/m2)
- •alcohol abuse
- •use of antipsychotics
- •communication barriers
- •local anesthetics allergy
- •chronic use of opioids
- •use of nonsteroidal anti-inflammatory drug use during the 24 hours immediately preceding surgery
- •coagulation disorders
- •infection at the needle insertion
- •conversion of laparoscopic to open cholecystectomy
研究组 & 干预措施
bupivacaine-dexmedetomidine
transversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1
干预措施: bupivacaine-dexmedetomidine (Drug)
bupivacaine
transversus abdominis plane block with bupivacaine 0.25%
干预措施: bupivacaine (Drug)
placebo
Transversus abdominis block with saline 0.9%
干预措施: placebo (Drug)
结局指标
主要结局
postoperative 24-hours cumulative morphine consumption
时间窗: for 24 hours after surgery
the retrieved postoperative 24-hours cumulative morphine consumption from the PCA pump report
次要结局
- postoperative pain at rest(for 24 hours after surgery)
- postoperative pain on movement(for 24 hours aftersurgery)
- sedation scores(For 24 hours after surgery)
- cumulative use of fentanyl(for 2 hours during surgery)
- Time to bowel recovery(for 24 hours after surgery)