Is Thoracic Paravertebral Block a Better Option Than Conscious Sedation for Percutaneous Radiofrequency Ablation of Liver Tumors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effectiveness of PVB on pain intensity
研究概览
简要总结
Percutaneus radiofrequency ablation (RFA) of liver tumors causes acute pain during the periooperative setting. In order to facilitate tumor access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious.
This study aims to assess the impact of a single shot thoracic paravertebral block (TPVB) on a patient's haemodynamic stability, patient's and operator's comfort and satisfaction during the operation and analgesia in the post-operative period.
详细描述
High temperatures used during the percutaneus radiofrequency ablation (PRFA) of liver tumors can cause acute pain in the perioperative setting. In order to facilitate tumor exposure and access, patient should collaborate with a surgeon during the procedurę, therefore should be conscious. It is mandatory to provide an adequate acute postoperative pain control for our patients.
This prospective randomized, single center study was approved by the Bioethics Committee at the University of Warmia and Mazury in Olsztyn, (Poland) under the resolution No. 46/2017.
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
Participants were randomly assigned into 2 groups (computerized randomization program).
group PVB - patients under paravertebral block anesthesia, group BB - patients under local anesthesia, without paravertebral block.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with primary liver tumor (HCC)
- •patient scheduled for an elective surgery
- •tumor diameter) <5 cm two tumors <3cm
- •Age >18 years
- •Physical State 1,2 or 3 of the American Society of Anesthesiology (ASA)
排除标准
- •ASA IV and V
- •Thrombocytopenia (<40x10 ^ 9 / L)
- •Severe cirrhosis (Child-Pugh C classification)
- •History of psychiatric/cognitive disease
- •Patients who do not give informed consent
- •Patients with contraindications or history of hypersensitivity to local anaesthesia drugs
- •History of chronic pain, chronic opioid use (> 3 months)
研究组 & 干预措施
group PVB
standard analgosedation + paravertebral thoracic blockade with 20 ml 0.25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa warszawa S.A.)
干预措施: thoracic paravertebral blockade (Procedure)
group BB
standard analgosedation + local anesthesia of the skin and subcutaneous tissue with 5ml 0,5% lignocaine (Lignocainum hydrochlorici, WZF 1%).
干预措施: local anaesthesia (Procedure)
结局指标
主要结局
Effectiveness of PVB on pain intensity
时间窗: 0,1,3,6,24 hours post surgery
The level of pain will be assessed in all groups (PVB and BB) basing on analgesic drugs consumption
Effectiveness of PVB on pain intensity
时间窗: NRS during the procedure and 0,1,3,6,24 hours post surgery
The level of pain will be assessed in all groups (PVB and BB) basing on the NRS scale (NRS 0- no pain, NRS 10 - the worst pain imaginable) Self reported pain intensity in 5 time points based on the numerical rating scale NRS (where 0 is no pain, 10 is the strongest pain). comparison of analgesic drug use in both groups
次要结局
- Patients' satisfaction(24 hours post surgery)
- Surgeon's satisfaction(0 h post surgery (immediately after surgery))
研究者
Malgorzata Braczkowska
Principal Investigator
University of Warmia and Mazury