The Beneficial Effect of Quadratus Lumborum Block After Laparoscopic Cholecystectomy in Day-Case Surgery: 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
- 75
- 试验地点
- 2
- 主要终点
- Use of analgesics -"change" is being assessed
研究概览
简要总结
The enhanced recovery after surgery and laparoscopic approach is essential after day-case surgery. The patients want to go home early without pain and nausea, and the hospitals need the post-operative capacity for more patients. Many patients have pains, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. The aim of the study is to find out if a bilateral quadratus lumborum block has a beneficial effect after a cholecystectomy.
详细描述
QLB (quadratus lumborum block) is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. Quadratus lumborum block for postoperative pain after caesarean section 2015). Transversus abdominis plane (TAP) block seems to be feasible and effective in postoperative pain control without increasing morbidity in cholecystectomy. QLB is also performed as one of the perioperative pain management procedures in abdominal surgery. It is regarded as an effective analgesic tool The dermatomal effects of QLB reach higher than the TAP block and might explain the better effect of the QLB than TAP blocks on postoperative pain after caesarean delivery. A randomized double blinded clinical trial with TAP block in patients scheduled for cholecystectomy is performed, but there is no good data for the QLB. For this study the investigators standardize the type of surgery to be laparoscopic day-case cholecystectomy, and we use the anterior (transmuscular) QLB.
Power and Sample Size Calculator The number of patients required for the study was calculated on the basis of opioid consumption. The investigators are interested in a reduction by 20% in the group given QLB. Assuming α=0,05, the calculation shows a need of 69 patients (23 in each group) to achieve a power of 80% (β=0.2).
75 adult patients scheduled for cholecystectomy have to be included. Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 10 ml. Maximum allowed dosis is 3 mg/kg BW (BodyWeight). Dosis reduction if BW<70 kg. All three groups receive necessary analgesics oral or parenteral.
Premedication: Paracetamol 2g and Diklofenak 100 mg
General anesthesia: TCI (Target Control of Infusion): Propofol and Remifentanil, Ondansetron 4 mg and Decadron 8 mg iv preoperatively. Oxycodon 5 mg iv at the end of the procedure.
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)
盲法说明
Information connecting the patients to the data are kept locked and will be destroyed after the end of the investigation
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 Years
- •BMI 20-35
- •ASA physical status I-II
排除标准
- •Allergy to local anaesthetics
- •Chronic pain requiring opioid analgesics
- •Patients with atrioventricular block II
- •Patients treated with class III antiarrhythmics
- •Patients with severe renal and/or hepatic disease
- •A coagulation disorder
- •An infection at the LA injection place
结局指标
主要结局
Use of analgesics -"change" is being assessed
时间窗: 1 week (0-4hrs) (4-24hrs) (24-48hrs)
Amount of analgesics used postoperative
次要结局
- Postoperative nausea and vomiting - "change" is being assessed(48 hours(0-4hrs) (4-24hrs) (24-48hrs))
- Pain at the incision site - "change" is being assessed(48 hours (0-4hrs) (4-24hrs) (24-48hrs))
- Deep pain and pain on coughing - "change" is being assessed(48 hours (0-4hrs) (4-24hrs) (24-48hrs))
- Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed(48 hours(0-4hrs) (4-24hrs) (24-48hrs))
研究者
Jan Sverre Vamnes
Senior consultant, MD, Ph.D.
Ostfold Hospital Trust