Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial.

BACKGROUND

Thoracic paravertebral block (TPVB) is a widely advocated regional technique for alleviating postoperative pain in children undergoing elective pectus excavatum repair. However, this technique is associated with some undesirable adverse events. Recently, the erector spinae plane block (ESPB) has been introduced as a practical alternative to the TPVB in thoracic surgery. This interfascial regional anesthesia technique interrupts pain sensation by injecting local anesthetics between the muscular layers of the thoracic wall. Several case series described it as an effective pain management technique following pectus excavatum repair. Therefore, this trial is designed to test the hypothesis that ESPB is non-inferior to TPVB in postoperative pain control after pectus excavatum repair.

METHODS

This is a prospective randomized double-blind non-inferiority trial. A total of 40 patients aged 4 to 18 years undergoing Nuss surgery will be randomly assigned to receive pain treatment with either ESPB or TPVB. All patients will receive additional systemic multimodal analgesia with an intravenous patient-controlled analgesia pump and acetaminophen. The primary outcome is the pain intensity at rest, 24 h postoperatively. Secondary outcomes include accumulated morphine-equivalent consumption, postoperative pain scores, emergence agitation incidence, time of the first mobilization, time to first rescue analgesia, complications related to pain treatment, and morphine-related adverse events.

DISCUSSION: This will the first randomized controlled trial to compare ESPB with TPVB for analgesia after pectus excavatum repair. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of ESPB in children.

TRIAL REGISTRATION: ClinicalTrials.gov NCT05034601 . This trial was prospectively registered.