University Hospital Antwerp
Edegem, Antwerp, 2560, Belgium
NCT Number: NCT07099469
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Edegem, Antwerp, 2560, Belgium
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.
References
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult patients of 18 years or older who are able to give informed consent and fill out questionnaires in Dutch.
Exclusion criteria
Time frame: 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.
Time frame: 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
The QoR-15 will provide a continuous variable with a minimum score of 0 and a maximum score of 150 and contains the most relevant questions concerning 5 domains (emotional status, physical comfort, psychological support, physical independence and pain) of overall well-being and recovery after surgery.
Time frame: From date of hospitalization until discharge, estimated time of hospitalisation is 5 days, but we will measure until discharge from the hospital.
Lenght of stay, defined as the total number of days in hospital after the surgical intervention.
Time frame: during the postopertieve hospotalization periode, day 0 till day 3
Cumulative use of systemic opioids and analgesics
Time frame: During the postopertieve hospotalization periode, day 0 till day 3
Proportion of postoperative pain scores of NRS >3 during mobilization
Time frame: During post-opertieve periode day 0 - day 3.
Measured using a likert 5-point scale going from Very unsatisfied to very satisfied.
Time frame: During post-opertieve periode day 0 - day 3, while hospilized.
Time to removal of the chest tube in days;
Time frame: During post-opertieve periode day 0 - day 3, while hospilized.
Time to removal of urinary catheter in days;
Time frame: During post-opertieve periode day 0 - day 3, while hospilized.
Degree of mobility (1-4 scale) at POD 1-3:
At POD 0 the degree of mobility is based on 2 options: patient hasn't been out of bed or went from bed to chair.
University Hospital, Antwerp
Other
A Randomized Pilot Study of ICNB With Ropivacaine Versus ICNB With Cryotherapy for Postoperative Pain Management After RATS Anatomical Resection for Lung Cancer.
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