A Randomized Controlled Trial Comparing Quadratus Lumborum Block and Paravertebral Block for Postoperative Analgesia in Laparoscopic Hepatectomy and Open Hepatectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- QoR-15/Quality of Recovery Scale 15(QoR-15)
研究概览
简要总结
Pain after hepatectomy can interfere with the patients' recovery and may contribute to developing long term pain. Opioids, e.g. morphine, fentanyl, sufentanil, works well for postoperative analgesia, but have several side effects such as nausea, vomiting and itching which may be severe enough to affect patients' recovery. In some cases, opioids may cause constipation and urinary retention within the first 24 hours after surgery. Thus, several ultrasound-guided nerve block procedures have been applied to provide postoperative analgesia. Ultrasound-guided thoracic paravertebral block (TPVB) is one of the most used nerve block methods using for post-hepatectomy analgesia. However, in some cases, ultrasound-guided TPVB can cause pneumothorax, hemopneumothorax, and higher block level. The quadratus lumborum block (QLB) is a new developed nerve block which can provide a widespread analgesic effect from T7 to L1. Therefore, this study is to determine whether QLB or TPVB have a better pain control with fewer side effects and complications after laparoscopic and open hepatectomy. The adequate pain control will be assessed by their visual analogue score (VAS) and the postoperative quality of recovery scale (QoR-15, Chinese Version). Additionally, the side effect and complications profile of these two nerve block techniques will also be recorded and compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
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
- •Patients aged between 18 and 65 years old for selective hepatectomy from nanfang Hospital, Southern Medical University
- •American Society of Anesthesiologists (ASA) risk class I-III;
- •Body Mass Index (BMI) is not lesser than 18 and not greater than 30;
排除标准
- •Patients refuse to participate
- •Allergy to the any agents used in current clinical trial;
- •Dependence, tolerance or excessive sensitivity to the anesthetics and psychotropic drugs;
- •Patients with nerve block contraindications (e.g. local infection of skin or soft tissue in injection site, serious bleeding tendency or hemorrhagic disease, anatomical aberration which make anesthesiologist cannot perform the ultrasound-guided nerve block, allergic history of local anesthetics, etc.);
- •Previous abdominal surgery (except for diagnostic biopsy);
- •New York Heart Association (NYHA) classification of cardiac function grade IV and/or Ejection Fraction (EF)≤55%;
- •Child-Pugh grading
- •Liver function of grade C (Child-Pugh grading)
- •Glomerular filtration rate≤60ml/min/1.73m2;
- •Obstructive sleep apnea syndrome;
- •Chronic obstructive pulmonary disease, asthma, active tuberculosis;
- •Cardiac rhythm disorders;
- •Past or present history of nervous system diseases and mental disorders (such as epilepsy, Alzheimer's disease, Parkinsonism syndrome, depression,etc.);
- •Autoimmune diseases (such as lupus erythematosus, rheumatoid arthritis,etc.)
- •Malignant tumors of other systems;
- •Other operations are required during the same period;
研究组 & 干预措施
PCA for Open Hepatectomy
Patient-controlled intravenous analgesia in Open hepatectomy (PCA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing)
干预措施: Patient-controlled intravenous analgesia (Other)
QLB for Open Hepatectomy
Bilateral quadratus lumborum block with 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Patient-controlled intravenous analgesia (Other)
QLB for Open Hepatectomy
Bilateral quadratus lumborum block with 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Quadratus Lumborum Block (Other)
TPVB for Open hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Patient-controlled intravenous analgesia (Other)
TPVB for Open hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Thoracic Paravertebral Block (Other)
PCA for Laparoscopic Hepatectomy
Patient-controlled intravenous analgesia in Laparoscopic hepatectomy (same as PCA for Open hepatectomy Arm)
干预措施: Patient-controlled intravenous analgesia (Other)
QLB for Laparoscopic Hepatectomy
Bilateral quadratus lumborum block 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Patient-controlled intravenous analgesia (Other)
QLB for Laparoscopic Hepatectomy
Bilateral quadratus lumborum block 20 ml 0.375% ropivacaine each side(maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Quadratus Lumborum Block (Other)
TPVB for Laparoscopic Hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Patient-controlled intravenous analgesia (Other)
TPVB for Laparoscopic Hepatectomy
T6+T8 of thoracic paravertebral block with 15 ml 0.375% ropivacaine each segment (maximum total dose 3 mg/kg) combine Patient-controlled intravenous analgesia (same as PCA for Open hepatectomy Arm)
干预措施: Thoracic Paravertebral Block (Other)
结局指标
主要结局
QoR-15/Quality of Recovery Scale 15(QoR-15)
时间窗: From 1 day before the surgery to the 2 days after surgery
The Quality of Recovery-15 scale (QoR-15) is an easy-to-use score for assessing the quality of post-operative recovery. The QoR-15 is a 15-item questionnaire intended to measure QoR after anesthesia and surgery. It comprises five subscales: pain (n = 2), physical comfort (n = 5), physical independence (n = 2), psychological support (n = 2), and emotional state (n = 4) . Each item is scored from 0 to 10, and the possible total score ranges from 0 to 150. A higher total score means better patient QoR.
VAS
时间窗: From 1 day before the surgery to the 2 days after surgery
The visual analogue scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. In current study visual analogue scale is be adopt to assess pain of patients. The VAS ranges from 0-10,0 represents no pain and 10 represents the worst pain.
次要结局
- Opioids consumption after hepatectomy(Up to 48 postoperative hrs)
- Nausea(Up to 48 postoperative hrs)
- Time to first off-bed activity(Up to discharge from hospital)
- Opioids consumption during hepatectomy Intraoperative opioids consumption(At the end of surgical procedure)
- First request of analgesia(Up to 48 postoperative hrs)
- Lower extremity muscle strength(Up to 48 postoperative hrs)
- Total opioids consumption(From admitting in operation room to 48 hours after hepatectomy)
- Vomiting(Up to 48 postoperative hrs)
- Sedation Score(Up to 48 postoperative hrs)
- Respiratory depression(Up to 48 postoperative hrs)
- Pruritus(Up to 48 postoperative hrs)