Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Patients Undergoing Left Hemicolectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 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 have been proven beneficial in surgery of the colon. However, patients have still pain, nausea and vomiting postoperatively. Postoperative pain is an expected but undesirable effect after an operation. This study will compare Transabdominis Plane (TAP) Block and Quadratus Lumborum (QL) Block with the common postoperative treatment with enteral and parenteral analgesics.
详细描述
TAP is a recommended multimodal method of reducing postoperative pain in laparoscopic and open surgery. TAP block seems to be feasible and effective in postoperative pain control without increasing morbidity in colon resections. QL block 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 QL block reach higher than the TAP block, and might explain the better effect of the QL block than TAP blocks on postoperative pain after caesarean delivery. For this study the investigators standardize the type of surgery to be left hemicolectomy. This is the most common procedure on colon.
Power and Sample Size Calculator:
The number of patients required for the study was calculated on the basis of opioid consumption. We were interested in a reduction by 20% in the group given QLB. Assuming α=0,05, we calculated that we need 69 patients (23 in each group) to achieve a power of 80% (β=0.2).
75 adult patients scheduled for left hemicolectomy have to be included.
Subcutaneous wound infiltration at the end of surgery in all patients with ropivacaine 2 mg/ml, 20 ml. Maximum allowed dosis of Ropivacain is 3 mg/kg bodyweight (BW), dosis reduction if BW<70 kg Premedication: Paracetamol 2 g and Diklofenak 100 mg orally. General anaesthesia: TCI: Propofol and Remifentanil Ondansetron 4 mg, dexamethasone 8 mg and Oxycodone 5 mg intravenously at the end of surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 LA
- •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
研究组 & 干预措施
Left hemicolectomy without nerve blocks
Left hemicolectomy, laparoscopic technique Enteral and parenteral analgesics such as paracetamol and oksykodon
干预措施: Left hemicolectomy, laparoscopic technique (Procedure)
Left hemicolectomy with TAP block
Left hemicolectomy, laparoscopic technique TAP block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml
干预措施: Left hemicolectomy, laparoscopic technique (Procedure)
Left hemicolectomy with QL block
Left hemicolectomy, laparoscopic technique QL block bilateral with Naropin 3,75 mg/ml, 2 x 20 ml
干预措施: Left hemicolectomy, laparoscopic technique (Procedure)
结局指标
主要结局
Use of analgesics - "change" is being assessed
时间窗: 1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs)
Amount of analgesics used postoperative
次要结局
- Sedation scores - "change" is being assessed(1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs))
- Postoperative nausea and vomiting - "change" is being assessed(1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs))
- Pain at the incision site - "change" is being assessed(1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs))
- Deep pain and pain on coughing - "change" is being assessed(1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs))
- Nonsteroidal anti-inflammatory drug consumption - "change" is being assessed(1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs))
- Antiemetic administered - "change" is being assessed(1 week (0-4 hrs) (4-24 hrs) (24-48 hrs) (48 - 168 hrs))
研究者
Jan Sverre Vamnes
Senior conultant, Ph.D.
Ostfold Hospital Trust
