Optimal postoperative pain management after VATS lung resection by thoracic epidural analgesia, continuous paravertebral block or single-shot intercostal nerve block (OPtriAL): study protocol of a three-arm multicentre randomised controlled trial

Abstract

Background 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). We 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. Methods This multi-centre randomised study is a three-arm clinical trial comparing PVB, ICNB and TEA in a 1:1:1 ratio for pain (non-inferiority) and QoR (superiority) in 450 adult patients undergoing VATS anatomic lung resection. Patients will not be eligible for inclusion in case of contraindications for TEA, PVB or ICNB, chronic opioid use or if the lung surgeon estimates a high probability that the operation will be performed by thoracotomy. Primary outcomes: (1) the proportion of pain scores ≥ 4 as assessed by the numerical rating scale (NRS) measured during postoperative days (POD) 0–2; and (2) the QoR measured with the QoR-15 questionnaire on POD 1 and 2. Secondary outcome measures are cumulative use of opioids and analgesics, postoperative complications, hospitalisation, patient satisfaction and degree of mobility. Discussion The results of this trial will impact international guidelines with respect to perioperative care optimization after anatomic lung resection performed through VATS, and will determine the most cost-effective pain strategy and may reduce variability in postoperative pain management. Trial registration The trial is registered at the Netherlands Trial Register (NTR) on February 1st, 2021 (NL9243). The NTR is no longer available since June 24th, 2022 and therefore a revised protocol has been registered at ClinicalTrials.gov on August 5th, 2022 (NCT05491239). Protocol version: version 3 (date 06-05-2022), ethical approval through an amendment (see ethical proof in the Study protocol proof).

Epidural analgesia versus oral morphine for postoperative pain management following video-assisted thoracic surgery

“… 33 However, due to the potential gravity of the complications, epidural catheters should be justified, and avoided if similar pain relief can be achieved without them. Evidence on the efficacy of alternative loco-regional analgesia techniques for postoperative pain management in VATS, especially the paravertebral block, is rapidly emerging, 34 , 35 and recent recommendations advocate its use over epidural analgesia. 8 However, further studies comparing epidural analgesia to other forms of postoperative pain management with emphasis on auxilary areas (e.g.…”

Analgesic effect of thoracic paravertebral block on patients undergoing thoracoscopic lobectomy under general anesthesia

“…Local anesthetics can inhibit the inward flow of Na + and K + in the nerve cell membrane, block the pain signal transmission, block somatic and sympathetic nerves, temporarily block the nerve excitation function of this segment, and inhibit the neurogenic stress response and pain sensation. 13 , 14 recovery, and to prevent pulmonary complications. So far, no consensus exists on optimal postoperative pain management after VATS anatomic lung resection.…”

Intercostal Catheters Reduce Long-Term Pain and Postoperative Opioid Consumption after VATS

“…Thoracic epidural analgesia (TEA) and single shot intercostal nerve block (SSINB) represent the current majority of techniques used for pain control [7]. Even though TEA is a very effective method, several disadvantages may arise, such as immobilization, bladder dysfunction, and phases of hypotension [11,12].…”

“…SSINB provides the same efficiency as TEA and is associated with less side effects. The issue of this method is the duration of the pain control, which is only for a limited period of time because of the single shot application [11,12].…”