Erector Spinae Plane (ESP) Block versus Thoracic Epidural Analgesia (TEA) in Video-Assisted Thoracic Surgery (VATS): A Prospective Randomized Open Label Non-Inferiority Trial

This is an investigator-initiated prospective randomized open label non-inferiority trial comparing the thoracic epidural (TEA) with the Erector Spinae Plane block (ESP) as regional anesthesia technique for VATS-surgery. The ESP-block is recently introduced in clinical practice as an easy, safe and reliable alternative to the thoracic epidural. This new technique injects local anesthetic within a plane beneath the erector spinae muscle to achieve analgesia (6).

A total of 90 patients are being randomly allocated to ESP (study group) or TEA (control group). Patients will be followed until 48 hours after surgery or until discharge from the hospital. Primary outcome is the Quality of Recovery 15 (QoR15) score. We hypothesize that the ESP is equally as effective as a TEA, without the disadvantages (bedrest, urinary catheter, rare but serious neurologic adverse events).

Effective postoperative pain control is an essential and humanitarian need of every surgical procedure. Inadequate pain control may result in increased mortality, delayed recovery and increased hospital costs (1). The optimal perioperative analgesic strategy is preemptive and involves the combined administration of local anesthetic techniques [local anesthetic infiltration, peripheral nerve blocks, and neuraxial blocks (epidural and paravertebral)], systemic analgesic agents (opioids, acetaminophen, non-steroidal anti-inflammatory drugs, and cyclooxygenase-2-specific inhibitors) and analgesic adjuncts such as steroids, ketamine, α-2 agonists, and anticonvulsants (2). This so-called multimodal approach improves the analgesic effect because of the synergizing effect between the different analgesia techniques and/or drugs.

Up until now, the epidural analgesia is the gold standard local anesthetic technique for VATS surgery (3). However, the invasiveness of this technique, the rare but serious neurologic complications and the failure rates up to 30% (4) have resulted in a search for alternatives. Alternatives include lower thoracic catheter placement, intercostal nerve blocks, paravertebral blocks, intrapleural catheters, local anesthetic infiltration, and systemic analgesia with one or more agents (4). However, none of these techniques were able to replace the thoracic epidural as gold standard due to (5) ‘too technically challenging’ or ‘insufficient analgesia’ (6). Recently the ESP-block has been introduced in clinical practice as an easy, safe and reliable alternative to the thoracic epidural. This new technique injects local anesthetic within a plane beneath the erector spinae muscle to achieve analgesia (6). The most significant advantage of the ESP-block is its simplicity and safety. The sonoanatomy is easily recognizable and there are no structures at risk of needle injury in the immediate vicinity (6). Case reports describe the successful application of the ESP-block for analgesia after VATS surgery (7,8), but evidence from large trials targeting a specific surgical population is lacking. To test the hypothesis that the ESP block with Continuous ESP Analgesia (ESP) is non-inferior in terms of the quality of recovery as measured by the Quality of Recovery 15 (QoR15) score compared to the thoracic epidural with continuous epidural analgesia (TEA) for patients undergoing elective unilateral VATS.

Patients will be followed until 48 hours after surgery or until discharge from the hospital. Thirty days after the surgery, patients will be contacted for a telephone survey.

Patients will be randomized (1:1) to receive either pain treatment with ESP (the study group) or TEA (the control group). Patients in the intervention group receive continuous ESP analgesia (ESP) with bupivacaine 0.125% and a PCIA pump with morphine. Settings of the continuous ESP analgesia are 10- 15ml/h, settings of the PCIA pump are according to local protocol. When ESP does not provide adequate pain relief, minor adjustments or a manual top-up are allowed. Patients in the control group receive thoracic epidural analgesia (TEA) through a continuous epidural analgesia (CEA) pump with bupivacaine 0.125% + sufentanil 1mcg/ml at 8 - 12ml/h. When CEA does not provide adequate pain relief, minor adjustments or a manual top-up are allowed.