Patient-Controlled Thoracic Paravertebral Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
试验速览
- 阶段
- 1 期
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Pain scores
研究概览
简要总结
Thoracic surgery is commonly associated with severe postoperative pain and marked impairment of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is assumed to result in better quality of life and less postoperative pain compared with standard open thoracotomy, other investigators have reported comparable patient-reported physical component summary and pain scores after VATS and thoracotomy during the first 12 months after lung resection.2 That study was non-randomized and 41% of the included patients did not complete the follow-up period.2 VATS has recently been increasing in popularity as a fast-track surgery with potential enhanced recovery after surgery.
Variety of approaches exist to manage pain after thoracotomy which could attenuate post-thoracotomy pulmonary dysfunction. Epidural analgesia has been considered for many decades to be the best method of pain relief after major thoracic surgery. In previous meta-analyses,3-5 many investigators have reported that thoracic paravertebral blockade (PVB) has comparable analgesic effects to thoracic epidural analgesia (TEA) in patients undergoing thoracotomy.
Additionally, PVB has a better side-effect profile, lower rates of failed block and is associated with a reduction in pulmonary complications.3-5 This could be extended to VATS to enhance recovery after surgery owing to effective analgesia and fewer side effects.6-7
Patient-controlled analgesia (PCA) has been advocated as a favourable model for postoperative analgesia, that allows a perfect match between intensity of pain and analgesic delivery, improves the quality of analgesia and decreases the cumulative analgesic consumption. Furthermore, the introduction of patient-controlled epidural analgesia (PCEA) with background infusion during labour gave patients a sense of control over their analgesia, reduced the total dose of local anesthetic administered, and had less motor block than those who receive continuous epidural analgesia.8-9Patient-controlled epidural analgesia (PCEA) has become increasingly popular for pain control after thoracotomy.10-12 In a previous preliminary study, McElwain et al.13 have reported satisfactory analgesia after breast cancer surgery with the use of PC-PVB, using either 15-min or 30-min lockout, that study did not include a comparative arm with a continuous paravertebral infusion. Furthermore, Abou Zeid et al. have reported comparable analgesia after thoracic surgery with the use of either patient-controlled PVB had with the use of intrathecal morphine, that study was not controlled and included few patients.14
The efficacy of the patient-controlled paravertebral blockade (PC-PVB) on the quality of postoperative analgesia and pulmonary function after VATS has not yet been studied.
详细描述
We hypothesizes that the use of patient-controlled paravertebral blockade (PC-PVB) after VATS will be associated with lower pain scores and less pulmonary dysfunction than continuous paravertebral blockade (PVB).
Following obtaining of the Local Ethics Committee approval and informed patient consent, 62 patients, aged 18 -70 years, American Society of Anesthesiologists (ASA) physical status II-III, undergoing elective VATS using postoperative thoracic paravertebral analgesia will be included in this prospective, randomized, controlled, double-blind study.
Before operation, forced expiratory volume in 1 s (FEV1), forced vital capacity (FVC), and peak expiratory flow rate (PEFR), were measured. On the morning before surgery, the patients will be instructed in the use of the PCA pump and a VAS. The patients will be asked to rate their experienced pain using the VAS from 0 to 100 mm with 0 representing no pain and 100 representing the worst imaginable pain.
Prior to the procedure an 18 to 20 G intravenous access will be established. Patient monitors includes electrocardiograph, non-invasive blood pressure, and pulse oximeter. All patients will be premedicated with iv midazolam 0.01-0.03 mg kg-1.
Before the induction of general anesthesia, paravertebral space ipsilateral to the thoracostomy will be identified 3 cm lateral to the spinous process of T5-8 with ultrasound-guidance (USG) using a high-frequency linear array probe of a Sonosite MTurbo ultrasound machine (MicroMaxxs ultrasound system, Sonosite Inc, Bothell, WA). After the probe was placed at the level of the T5-6 interspace, the apex of the paravertebral space will be visualized as a wedge-shaped hypoechoic space surrounded by the hyperechoic line of the pleura below and the internal intercostal membrane above. An 18 G Tuohy needle (B. Braun, Germany) will be inserted in a lateral-to-medial direction using an in-plane approach and will be kept advancing until the needle tip penetrates the internal intercostal membrane.7 A 20-G epidural catheter (B. Braun, Germany) will be introduced through Tuohy needle and advanced 3 cm into the paravertebral space. After gentle aspiration, a test dose of 3 mL of bupivacaine 0.25% with epinephrine 5 µg mL-1 will be administered through the catheter. If no significant rise in heart rate or arterial pressure will be observed, a bolus of 0.3 mL kg-1 of bupivacaine 0.25% with epinephrine (5 µg mL-1), followed by continuous paravertebral infusion of bupivacaine 0.25% and fentanyl 2 µg mL-1 at 0.1 mL kg-1 h-1 intraoperatively.15
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status II-III.
- •Use of postoperative thoracic paravertebral analgesia
排除标准
- •Cardiac disease
- •Pulmonary disease
- •Renal disease
- •Hepatic disease
- •Neuropsychiatric disease
- •Pregnancy
- •Bleeding disorder
- •Severe anatomical abnormalities of the vertebral column or ribs
- •Allergy to study medications
- •Other contraindications to paravertebral analgesia
- •Body mass index (BMI) ≥ 35 kg m-2
- •Body weight less than 50 kg
- •Emergency surgery
- •Preoperative pain score > 70 mm on visual analogue scale (VAS)
- •Drug or alcohol abuse
- •Chronic pain condition requiring daily intake of analgesics
- •Language or mental disorders
结局指标
主要结局
Pain scores
时间窗: 48 hours after surgery
Pain scores on a 100-mm-long visual analog score (VAS) at rest and on cough
次要结局
- Number of bolus demands(48 after surgery)
- Rescue analgesic requirements(48 hours after surgery)
- Requirement for antiemetic medication(48 hours after surgery)
- Actual number of boluses(48 hours after surgery)
- Overall patient satisfaction(48 hours after surgery)
- Hemodynamic variables(48 hours after surgery)
- Sedation scores(48 hours after surgery)
- Pulmonary function tests(24 hours before surgery, 72 hours after surgery)
- Total volume of administered bupivacaine(48 hours after surgery)