In Response

Abstract

We read with interest the comments by Grocott1 and Chin and Barrington2 on our study.3 Though the efficacy of erector spinae plane (ESP) block has been reported in many publications, we believe that our study is one of the earliest prospective randomized controlled trials (RCTs) that documented the potential benefits of this regional anesthetic technique. The author commented on the difference between the registered end points in the Pan African Clinical Trials Registry (PACTR) and those reported in our study. At the time of registering the trial, we planned to evaluate the visual analog scale (VAS) of pain as our primary outcome. However, after registration, we thought it would be better to report VAS at 2 hours postoperative as the primary outcome, because it would be a surrogate of block success because we did not perform sensory assessment of dermatomal block to maintain the double-blinded nature of the trial. Yet, we assessed VAS along the first 24 hours postoperatively and reported them as secondary outcomes. The time to the first rescue analgesic request was not registered as a secondary outcome in the PACTR. The registered outcomes, as well as the published secondary outcomes, included the consumption of intraoperative fentanyl and the 24-hour rescue analgesic consumption. We thank the author for pointing out the fact that most of the RCTs, including ours, lack the reporting of any patient-centered outcomes. We agree with him that the reporting of the standardized end points suggested by The Standardised Endpoints in Perioperative Medicine (StEP) initiative4 would facilitate future clinical trials assessing patient comfort and pain after surgery. However, Myles et al4 in their systematic review suggested that those end points are still to be evaluated and updated. They also suggested that other factors, other than those reported end points, might eventually be found to be valid and patient-centered. Though our RCTs did not report those patient-centered outcomes, which is an obvious limitation, we assessed postoperative VAS scale of pain for the first 24 hours postoperatively because we mainly focused on analgesic effects of the ESP block, and that was the main outcome of our study. We also reported the incidence of nausea and vomiting as a complication. We recommend further implementation of those end points in future RCTs evaluating any regional anesthetic technique and assessment of other potential patient-centered outcomes. Though our publication had some limitations, and based on our results, we believe that ESP is a promising regional anesthetic technique. Mohamed M. Abu Elyazed, MDShaimaa F. Mostafa, MDMohamed S. Abdelghany, MDGehan M. Eid, MDDepartment of Anesthesia and Surgical ICUFaculty of MedicineTanta UniversityTanta, Egypt[email protected]