Continuous Paravertebral Block by Intraoperative Direct Access Versus Systemic Analgesia for Postthoracotomy Pain Relief
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 主要终点
- Pain score on visual analogue scale (VAS) at rest
研究概览
简要总结
to evaluate the safety and efficacy of continuous paravertebral block by intraoperative direct access on postthoracotomy pain compared to systemic analgesia.
详细描述
Based on a pilot study of 20 participants, 10 in each group, the mean visual analogue score of pain at rest (VAS) ± Standard Deviation (SD) at 6 hours postoperatively for Thoracic paravertebral block group (TPVB) participants were 3.0 ± 1.4 and that for systemic analgesia (SA) participants were 4.2 ± 1.6. The calculated significant sample size with a power of 0.85 and alpha error of 0.05 was 60 participants, with 1:1 allocation in each group.
Eighty two participants were assessed for eligibility criteria to be included in the study, 18 participants were excluded pre-randomization, and one participant was excluded post-randomization due to re-exploration for bleeding. Sixty three participants were analyzed in the study. Thoracic paravertebral block group (TPVB group) included 32 participants and systemic analgesia group (SA group) included 31 participants.
Technique of intraoperative paravertebral catheter insertion:
The investigators used the technique that was described by Sabanathan et al in 1988[14] and modified by them in 1990 [15]. After completing the surgical pulmonary procedure and with the chest is still open, starting from the posterior end of the thoracotomy, parietal pleura is raised from the posterior chest wall to the vertebral body and for two spaces above and below the incision of thoracotomy creating a pouch. A 16-gauge disposable Tuohy needle is inserted percutaneously through a low posterior interspace. The needle is advanced until the tip appeared in the created pouch. The stylet is removed, and a 16-gauge side-holed epidural catheter is advanced into the created pouch and the needle is withdrawn. Using a curved forceps, a small defect is done in the extrapleural fascia to be directly in the paravertebral space. The cannula is passed to the paravertebral space through the defect and advanced cranially for 2 to 3 cm. The parietal pleura is reattached to the posterior edge of the wound and the catheter is secured. Then a bolus dose 15-20 ml of 1% lidocaine is injected through the catheter and the chest is closed as usual with one or two intercostal drainage tubes according to the surgical procedure.
Protocol of analgesia:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Elective posterolateral thoracotomy surgery
- •American Society of Anesthesiologists (ASA) physical status of II and III
排除标准
- •• lack of patient consent.
- •patients younger than 18 years,
- •emergency surgery,
- •previous thoracotomy,
- •drug addiction,
- •allergy to paracetamol (acetaminophen) or ketorolac,
- •coagulopathy,
- •hepatic dysfunction,
- •chronic renal failure,
- •history of gastric ulcer
研究组 & 干预措施
Thoracic paravertebral block group
Continuous thoracic paravertebral block with 1% lidocaine infusion for 3 postoperative days through a paravertebral catheter inserted intraoperatively by the surgeon.
干预措施: Thoracic paravertebral block (Combination Product)
Systemic analgesia group
patients in this group will receive paracetamol and ketorolac by intravenous infusion every 6 hours for 3 postoperative days
干预措施: Systemic analgesia (Drug)
结局指标
主要结局
Pain score on visual analogue scale (VAS) at rest
时间窗: 24 hours after operation
Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
Pain score on visual analogue scale (VAS) on coughing
时间窗: 24 hours after operation
Paper-based visual analogue scale (VAS) is used for pain assessment. It provides a range of scores from 0-10. A higher score indicates greater pain intensity.
次要结局
- Total morphine consumption(end of first postoperative day)
- Forced vital capacity (FVC)(24 hours after operation)
- Forced expiratory volume in 1s (FEV1)(24 hours after operation)
- Peak expiratory flow rate (PEFR)(24 hours after operation)
研究者
Ahmed Deebis
Professor cardiothoracic surgery
Zagazig University
