Adequate pain control after video-assisted thoracoscopic surgery (VATS) for lung resection is important to improve postoperative mobilisation, recovery, and to prevent pulmonary complications. So far, no consensus exists on optimal postoperative pain management after VATS anatomic lung resection. Thoracic epidural analgesia (TEA) is the reference standard for postoperative pain management following VATS. Although the analgesic effect of TEA is clear, it is associated with patient immobilisation, bladder dysfunction and hypotension which may result in delayed recovery and longer hospitalisation. These disadvantages of TEA initiated the development of unilateral regional techniques for pain management. The most frequently used techniques are continuous paravertebral block (PVB) and single-shot intercostal nerve block (ICNB). The investigators hypothesize that using either PVB or ICNB is non-inferior to TEA regarding postoperative pain and superior regarding quality of recovery (QoR). Signifying faster postoperative mobilisation, reduced morbidity and shorter hospitalisation, these techniques may therefore reduce health care costs and improve patient satisfaction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
450
After correct placement of the epidural catheter, a local anaesthetic (ropivacaine, levobupivacaine or bupivacaine) will be started and, according to in house protocols, an opioid will be added to the epidural solution. A provisional stop of the administration of the epidural infusion is planned after 48 hours (on the second postoperative day).
The PVB catheter is placed under general anaesthesia at the beginning of the VATS procedure under direct thoracoscopic vision. The level of the PVB catheter placement is chosen at the intercostal space of the largest incision (mostly thoracic level 4 or 5). Under direct thoracoscopic vision, the surgeon inserts a Touhy needle. The tip of the needle is observed beneath the pleural surface thoracoscopically. Injection of about 2 mL ropivacaine 7.5mg/mL will create subpleural hydrodissection to reach the adequate paravertebral plane for placement of the catheter. The PVB catheter is subsequently placed under direct thoracoscopic vision and left next to the sympathetic chain in the paravertebral space. Next, a bolus of ropivacaine (total amount 20 mL including the given amount for hydrodissection) is given through the catheter. Postoperatively, a ropivacaine 2 mg/mL pump for continuous infusion is given with an infusion rate of 8-14 ml/hour.
At the end of the surgery a single shot ICNB will be placed at 9 levels (thoracic level 2 to 10) with 2-3mL local anaesthetics per intercostal space under direct thoracoscopic vision. The injection site will be chosen just lateral from the sympathetic trunk. This group will have no analgesic catheters for continuous analgesia. No mobility restrictions are instructed in this group.
Maxima MC
Veldhoven, Netherlands
Pain scores
Proportion of pain scores ≥4 as assessed by the numerical rating scale (NRS) (measured from 0 until 10; lowest value signifying no pain and highest value signifying worst pain)
Time frame: Postoperative day 0-2
Quality of Recovery (QoR)
QoR measured with the QoR-15 questionnaire on postoperative 1 and 2 (maximum score of 150, the higher the score the better the outcome)
Time frame: Postoperative day 1-2
cumulative use of opioids and analgesics
total opioid and non-opioid consumption as supplementary analgesic requirement
Time frame: Postoperative day 0 until 3 as well as the use and dosage of opioid use at the follow-up period 2-3 weeks after the operation
postoperative complications
according to the Clavien-Dindo classification;
Time frame: until 2-3 weeks of follow-up
hospitalisation
defined as the total number of days in hospital after the surgical intervention (including readmissions within the first 30 postoperative days), the following standardised discharge criteria after surgery will be applied in all participating hospitals: normal intake of nutrition, independent mobility, absence of fever (\<38 °C), and no presence of chest tube;
Time frame: 30 postoperative days
patient satisfaction
5-point Likert scale: not at all satisfied, slightly satisfied, neutral, very satisfied and extremely satisfied
Time frame: Postoperative day 0 until 3
degree of mobility
4-point scale: on the bed (1), to the chair (2), to the toilet (3), outside the patient's hospital room(4)
Time frame: Postoperative day 0 until 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.