Randomized control trial of ultrasound-guided erector spinae block versus shoulder periarticular anesthetic infiltration for pain control after arthroscopic shoulder surgery: Study protocol clinical trial (SPIRIT compliant)

Mark Czuczman, Harsha Shanthanna, Bashar Alolabi, Peter Moisiuk, Turlough O'Hare, Moin Khan, Mauricio Forero, Kimberly Davis, Jaydeep Moro, Thuva Vanniyasingam, Lehana Thabane, Mark Czuczman, Harsha Shanthanna, Bashar Alolabi, Peter Moisiuk, Turlough O'Hare, Moin Khan, Mauricio Forero, Kimberly Davis, Jaydeep Moro, Thuva Vanniyasingam, Lehana Thabane

Abstract

Introduction: Moderate to severe postoperative pain and associated opioid use may interfere with patients' well-being and course of recovery. Regional anesthetic techniques provide an opportunity for opioid sparing and improved patient outcomes. A new regional technique called the erector spinae plane (ESP) block has the potential to provide effective analgesia after shoulder arthroscopy with minimal risks and decreased opioid consumption. Our primary objective is to determine whether, in patients who undergo arthroscopic shoulder surgery, a preoperative ESP block reduces pain scores as compared to periarticular infiltration at the end of surgery. Additionally, we will also examine other factors such as opioid consumption, sensory block, adverse events, patient satisfaction, and persistent pain.

Methods: This is a 2-arm, single-center, parallel-design, double-blind randomized controlled trial of 60 patients undergoing arthroscopic shoulder surgery. Eligible patients will be recruited in the preoperative clinic. Using a computer-generated randomization, with a 1:1 allocation ratio, patients will be randomized to either the ESP or periarticular infiltration group. Patients will be followed in hospital in the postanesthesia care unit, at 24 hours, and at 1 month. The study with be analyzed as intention-to-treat.

Discussion: This study will inform an evidence-based choice in recommending ESP block for shoulder arthroscopy, as well as providing safety data. The merits of the study include its double dummy blinding to minimize observer bias, and its assessment of patient important outcomes, including pain scores, opioid consumption, and patient satisfaction. This study will also help provide an estimate of the incidence of side effects and complications of the ESP block.

Trial registration number: NCT03691922; Recruited Date of registration: October 2, 2018.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
ESP versus PAI for arthroscopic shoulder surgeries study consolidated standards for reporting trials flow diagram. ESP = erector spinae plane block, PAI = periarticular infiltration.

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Source: PubMed

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