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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).

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.

SUBMITTER: Czuczman M

PROVIDER: S-EPMC7220186 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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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).

Czuczman Mark M Shanthanna Harsha H Alolabi Bashar B Moisiuk Peter P O'Hare Turlough T Khan Moin M Forero Mauricio M Davis Kimberly K Moro Jaydeep J Vanniyasingam Thuva T Thabane Lehana L

Medicine 20200401 15

<h4>Introduction</h4>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 ...[more]

PMID: 32282729

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Project description:BackgroundIneffective management of postoperative pain following pediatric cardiac surgeries adversely affects a patient's postoperative course. The erector spinae plane (ESP) block has been described in the literature regarding perioperative pain management. We hypothesized that bilateral ESP blocks in pediatric patients would decrease intraoperative fentanyl consumption, reduce the need for postoperative morphine consumption, and improve pain scores.ObjectivesThe aim of this double-blinded randomized controlled trial was to assess the efficacy and safety of bilateral ESP blocks in pediatric patients undergoing cardiac surgeries through a median sternotomy.MethodsThe study involved 98 children aged 6 months to 7 years who were American Society of Anesthesiologists (ASA) II and III and scheduled for cardiac surgery through a median sternotomy. Patients were divided randomly into 2 groups: the ES group (n = 50) who received bilateral ultrasound-guided ESP blocks, and the N group (n = 48) who received no block. The primary outcome was the total dose of administered fentanyl intraoperatively. Secondary outcomes included morphine consumption in the first 24 hours postoperatively; the length of time before the first need for postoperative analgesia; and FLACC (face, legs, activity, consolability, and cry) scores at the first and second hours postoperatively and every 4 hours, with readings taken for a period of 24 hours.ResultsThere were statistically significantly higher levels of administered fentanyl intraoperatively (6.7 ± 3 vs 4.3 ± 1.9 µg.kg-1) and postoperative morphine consumption (0.5 ± 0.2 vs 0.4 ± 0.2 mg.kg-1) in the N group compared with the ES group (P < 0.001). Moreover, the timing of the first rescue analgesia was significantly delayed in the ES group compared with the N group (231.6 ± 104.5 vs 108.8 ± 47.8 minutes).ConclusionsBilateral ultrasound-guided ESP blocks can be used to reduce perioperative opioid consumption in pediatric patients undergoing cardiac surgery through a sternotomy. It also can be used to decrease postoperative pain scores.

Dataset Information

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).

Publications

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).

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