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临床试验/NCT07099469
NCT07099469进行中(未招募)不适用

A Randomized Pilot Study of ICNB With Ropivacaine Versus ICNB With Cryotherapy for Postoperative Pain Management After RATS Anatomical Resection for Lung Cancer.

University Hospital, Antwerp2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2025年3月25日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
6
试验地点
2
主要终点
The NRS pain score

研究概览

简要总结

This is a pilot study in which a total of 6 people will participate. This study aims to optimize the postoperative pain management of an anatomically minimally invasive lung resection (RATS) by comparing 2 pain-relieving techniques. As standard, an intercostal block is placed at the end of the procedure by injecting a local anesthetic at the site where the patient will be operated on. This study compares the previous method with the use of cryotherapy as an intercostal block. This technique uses cryo probes and blocks postoperative pain for 1-3 months. By comparing both techniques, it is examined whether cryotherapy requires less pain medication and is therefore more effective.

详细描述

Adequate pain control after robotic-assisted thoracic surgery (RATS) for lung resection is important to improve postoperative mobilisation and recovery, and to prevent postoperative pulmonary complications.

Thoracic epidural analgesia (TEA) is the usual care for postoperative pain management following thoracic surgery. Although the analgesic effect of TEA is clear, failure rates are 9-30% [1, 2, 3] and awake placement is stressful for patients. In addition, TEA is associated with patient immobilisation, bladder dysfunction and hypotension [4]. Based on the best available evidence and the recent guidelines by the Enhanced Recovery After Surgery (ERAS) society, the European Society of Thoracic Surgeons (ESTS) includes early mobilisation after surgery as one of their key recommendations [5]. The department of Thoracic Surgery of the Antwerp University Hospital (UZA) has developed its own ERAS protocol for minimal-invasive lung surgery. The standard technique for this protocol is single-shot intercostal nerve blockade (ICNB) with ropivacaine.

This study wants to evaluate single-shot ICNB with ropivacaine versus ICNB with cryotherapy. Single-shot peripheral nerve blockade has a risk for increased need for opioids and less patient satisfaction compared to a continuous infusion technique, especially when using a multi-port robotic technique [6]. On the other hand, the technique is good in the majority of cases, easy to perform, low costs compared to the standard TEA care [7] and there is a lower incidence of adverse events [8]. Unilateral regional techniques are not associated with patient immobilisation, bladder dysfunction and hypotension [9]. The ICNB with cryotherapy is a newer technique with the advantage of blocking post-surgical pain for 1 to 3 months, while allowing the axons to regenerate. The risk for additional medication is therefore less. However, the disadvantage is the fact that the probes developed to induce this block are expensive and not refunded in Belgium. For this small randomized pilot study, 3 cryotherapy probes are given for free by the company AtriCure. This offers us the opportunity to study the outcome of ICNB with cryotherapy and ropivacaine (standard technique).

Postoperative pain that is not effectively treated or controlled will lead to chronic pain which is hard to control. Because of this it is really important to have an effective strategy in the first 3 months post-op to reduce chronic pain [10, 11]. With this study the investigators want to compare 2 techniques to see which analgesic single-shot technique meets the patient's satisfaction and it will also determine the most cost-effective pain strategy. When ICNB with cryotherapy seems promising compared to ICNB with ropivacaine in terms of patient satisfaction and pain control, a larger trial can be initiated.

The results of this study will give the investigators a first idea whether ICNB with cryotherapy can offer a clear advantage over ICNB with ropivacaine.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients of 18 years or older who are able to give informed consent and fill out questionnaires in Dutch.

排除标准

  • Patients who need an anatomic resection of the lung that's larger than one lung lobe, who have CPAM or infections.
  • Patients with chronic use (>3 months) of strong opioids because of co-morbidities -for example, the use of tramadol is allowed.
  • If there's a high risk of conversion to a thoracotomy. This will be evaluated by the lung surgeon.
  • Patients who have had thoracic surgery in the past.
  • Patients with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min)

研究组 & 干预措施

R-ICNB

At the end of the procedure, an intercostal block is placed by injecting a local anesthetic into the site of surgery.

C-ICNB

At the end of the surgery single shot cryotherapy will be placed at 6 levels (T3-T8) with the AtriCure"s cryoICE cryosphere cryoablation probes.

结局指标

主要结局

The NRS pain score

时间窗: Baseline, post-operative (day 0) in the recoveryward when the patient is awake and after 6 hours. Day 1-2-3 the NRS wil be measured in the morning, afternoon and evening. During the Follow-up visits: 2 weeks and 12 weeks after surgery

The NRS score will be used to measure pain scores and this will be the primary outcome of the study.

次要结局

  • QoR-15 questionnaire(Measured at baseline, post-operative after surgery day 0, day 1, day 2 day 3 and day 4 during hospitalisation. At Folluw-up visit after 2 weeks and after 12 weeks)
  • Chest tube days(During post-opertieve periode day 0 - day 3, while hospilized.)
  • Lenght of stay(From date of hospitalization until discharge, estimated time of hospitalisation is 5 days, but we will measure until discharge from the hospital.)
  • Use of pain medication(during the postopertieve hospotalization periode, day 0 till day 3)
  • Pain during mobilization(During the postopertieve hospotalization periode, day 0 till day 3)
  • Patient satisfaction(During post-opertieve periode day 0 - day 3.)
  • urinary catheter in situ days(During post-opertieve periode day 0 - day 3, while hospilized.)
  • Degree of mobility(During post-opertieve periode day 0 - day 3, while hospilized.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeroen Hendriks

Prof. Dr. J. Hendriks

University Hospital, Antwerp

研究点 (2)

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