Efficacy of Surgically Placed Intercostal Catheter (ICC) for Postoperative Analgesia After Minimally Invasive Anatomical Lung Resection Using Ropivacaine: A Randomised, Double-blind, Placebocontrolled, Superiority Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- change in pain numerical rating scale (NRS) while coughing
研究概览
简要总结
This study is to examine the analgesic effectiveness of continuous loco-regional analgesic application (ropivacaine) through surgically placed Intercostal Catheter (ICC) and to establish correctly this method as a possible standard of care in the postoperative analgesia after Video-assisted thoracoscopic surgery (VATS) anatomical lung resection.
详细描述
Good control of the pain without excessive use of opiates supports the benefits of minimally invasive surgical procedure.
This study is to examine the efficacy of continuously via surgically placed intercostal catheter administered ropivacaine at a flow rate of 6-8 ml/h of 2 mg/ml on post-operative pain (NRS) and pulmonary function (FEV1, PEF) during a maximum of 72 ± 2 hours after skin closure. Patients undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia with confirmed or anticipated Stage I Lung cancer will be included. The study will be conducted as superiority, double-blind, placebo-controlled, randomized. The efficacy of loco-regional administered ropivacaine will be compared to placebo (NaCl, 0.9%) administration. The whole study period per participant is expected to be 6 months. In the follow-up, 6 months after surgery, the impact of ropivacaine on long-term pain (NRS, McGill) and pulmonary function (FEV1, PEF) shall be evaluated.
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)
盲法说明
All investigators, care providers, data analyst and trial participants are blinded
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
- •Informed Consent as documented by signature
- •Patient undergoing video-assisted thoracoscopic anatomical resection of the lung under general anaesthesia for confirmed or anticipated Stage I lung cancer (UICC 8th edition)
- •American Society of Anesthesiologists (ASA) physical status classes I to III
排除标准
- •NRS while coughing > 0
- •Previous ipsilateral thoracotomy or sternotomy
- •Abdominal or contralateral thoracic surgery up to 6 months preoperatively
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
- •Contraindications to self-administration of opioids
- •Women who are pregnant or breast feeding
- •Chronic steroid therapy (e.g. Prednisone > 10mg/day for more than last 2 weeks before surgery)
- •Chronic, daily pain therapy
- •Congestive heart failure
- •Liver insufficiency
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Enrolment of the investigator, his/her family members, employees and other dependent person
研究组 & 干预措施
Experimental Intervention Ropivacain
Ropivacain Fresenius 0.2% is a solution for infusion/ injection and will be continuously administered with an elastomer pump through the surgically placed intercostal catheter (ICC) between parietal pleura and fascia endo-thoracica at the level of surgical incision for a maximum of 72 hours at an initial standard flow rate setting of 6 ml/h using 2 mg/ml ropivacaine. In case pain exceeds 7 on NRS later than 2 hours after skin closure the flow rate will be adjusted on 8 ml/h. Furthermore, Ropivacain Fresenius 0.2% will be provided in a 20 ml glass vial for flushing the infusion line and subpleural administration.
干预措施: Ropivacain (Drug)
Control Intervention Placebo
Placebo (NaCl 0.9% B. Braun) is an isotonic solution for infusion and will be continuously administered with an elastomer pump through the surgically placed intercostal catheter (ICC) between parietal pleura and fascia endo-thoracica at the level of surgical incision for a maximum of 72 hours at an initial standard flow rate setting of 6 ml/h using NaCl 0.9%. In case pain exceeds 7 on NRS later than 2 hours after skin closure the flow rate will be adjusted on 8 ml/h. Furthermore, NaCl 0.9% will be provided in a 20 ml glass vial for flushing the infusion line and for subpleural administration, which will be prepared by the hospital pharmacy.
干预措施: NaCl 0.9% (Drug)
结局指标
主要结局
change in pain numerical rating scale (NRS) while coughing
时间窗: before surgery, at 2, 4, 8, 24, 48, 72 hours after skin closure
change in pain NRS (scale 0-10) while coughing in the Ropivacaine arm compared to Placebo arm; 0 = no pain to 10 = worst pain imaginable
次要结局
- change in pain NRS at rest(before surgery, at 2, 4, 8, 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery)
- change in forced expiratory volume in 1 second (FEV1)(before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery)
- change in peek expiratory flow (PEF)(before surgery, at 24, 48 and 72 hours after skin closure, 1 day before hospital discharge and 6 months ± 28 days after surgery)
- change in the short-form McGill Questionnaire (SF-MPQ)(before surgery, 48 hours after skin closure and 6 months ± 28 days after surgery)
- length of hospital stay(in the average within 30 days postoperative)
- 30 day mortality(within 30 days postoperative)
- number of gastrointestinal tract events(within 72 ± 2 hours postoperative)
- time to first defecation(in the average within 30 days postoperative)
- number of daily postoperative pain killer consumption(within 72 ± 2 hours postoperative)
- change in Silverman integrating approach (SIA) score, combined rank-based analysis of pain score and opioid consumption.(within 72 ± 2 hours postoperative)
- Patient Controlled Analgesia (PCA) demand(within 72 ± 2 hours postoperative)
- duration of chest tube chest tube(within 72 ± 2 hours postoperative)