Continuous erector spinae plane block versus thoracic epidural analgesia in video-assisted thoracic surgery: a study protocol for a prospective randomized open label non-inferiority trial.

BACKGROUND

Thoracic epidural analgesia is considered the gold standard for pain relief in video-assisted thoracoscopic surgery. This neuraxial technique blocks pain sensation by injecting a local anesthetic agent in the epidural space near the spinal cord to block spinal nerve roots. Recently, the erector spinae plane block has been introduced as a practical alternative to the thoracic epidural. This interfascial regional anesthesia technique interrupts pain sensation by injecting a local anesthetic agent in between the muscular layers of the thoracic wall. Several case series and three RCTs described it as an effective pain management technique in video-assisted thoracoscopic surgery (Scimia et al., Reg Anesth Pain Med 42:537, 2017; Adhikary et al., Indian J Anaesth 62:75-8, 2018; Kim, A randomized controlled trial comparing continuous erector spinae plane block with thoracic epidural analgesia for postoperative pain management in video-assisted thoracic surgery, n.d.; Yao et al., J Clin Anesth 63:109783, 2020; Ciftci et al., J Cardiothorac Vasc Anesth 34:444-9, 2020). The objective of this study is to test the hypothesis that a continuous erector spinae plane block incorporated into an opioid-based systemic multimodal analgesia regimen is non-inferior in terms of the quality of postoperative recovery compared to continuous thoracic epidural local anesthetic-opioid analgesia in patients undergoing elective unilateral video-assisted thoracoscopic surgery.

METHODS

This is a prospective randomized open label non-inferiority trial. A total of 90 adult patients undergoing video-assisted thoracoscopic surgery will be randomized 1:1 to receive pain treatment with either (1) continuous erector spinae plane block plus intravenous patient-controlled analgesia with piritramide (study group) or (2) continuous thoracic epidural analgesia with a local anesthetic-opioid infusate (control group). All patients will receive additional systemic multimodal analgesia with paracetamol and non-steroidal anti-inflammatory drugs. The primary endpoint is the quality of recovery as measured by the Quality of Recovery-15 score. Secondary endpoints are postoperative pain as Numerical Rating Score scores, length of hospital stay, failure of analgesic technique, postoperative morphine-equivalent consumption, itching, nausea and vomiting, total operative time, complications related to surgery, perioperative hypotension, complications related to pain treatment, duration of bladder catheterization, and time of first assisted mobilization > 20 m and of mobilization to sitting in a chair.

DISCUSSION: This randomized controlled trial aims to confirm whether continuous erector spinae plane block plus patient-controlled opioid analgesia can equal the analgesic effect of a thoracic epidural local anesthetic-opioid infusion in patients undergoing video-assisted thoracoscopic surgery.

TRIAL REGISTRATION: Netherlands Trial Register NL6433 . Registered on 1 March 2018. This trial was prospectively registered.