Dataset Information

Erector spinae plane block for minimally invasive mitral valve surgery: a double-blind, prospective, randomised placebo-controlled trial-a study protocol.

ABSTRACT:

Introduction

In the context of enhanced recovery after cardiac surgery, surgical techniques for mitral valve surgery have witnessed substantial modifications, from approaching the heart using open approaches with traditional sternotomy to thoracoscopic access via minithoracotomy. After cardiac surgery, acute postoperative pain is frequent and caused by surgical incision and retraction. Perioperative analgesia in cardiac surgery still relies mainly on opioids. Although neuraxial techniques could be a valuable non-opioid-based analgesia regimen, they can be associated with devastating complications in situations with (iatrogenic) coagulation abnormalities. Only two randomised clinical trials describe the erector spinae plane (ESP) block to provide sufficient postoperative analgesia following cardiac surgery with median sternotomy. Regarding postoperative analgesia after cardiac surgery with a minithoracotomy approach, adequately designed trials are still lacking. We, therefore, designed a double-blind, placebo-controlled trial to prove the hypothesis that the ESP block reduces opioid consumption in patients undergoing minimally invasive mitral valve surgery (MIMVS).

Methods and analysis

Sixty-four patients undergoing MIMVS will be included in this double-blind, prospective, placebo-controlled trial. Patients will be randomised to receive an ESP block with a catheter with either intermittent ropivacaine 0.5% (ropi group) or normal saline 0.9% (placebo group). Both groups will receive patient-controlled intravenous analgesia with morphine following extubation. Primary endpoint is the 24-hour cumulative morphine consumption after extubation. Multiple secondary endpoints will be evaluated.

Ethics and dissemination

The study is approved by the ethics committee of the University Hospitals Leuven, the Clinical Trials Centre of the University Hospitals Leuven and the 'Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten'. Dissemination of the study results will be via scientific papers.

Trial registration number

EudraCT identifier: 2019-001125-27.

SUBMITTER: Hoogma DF

PROVIDER: S-EPMC8023758 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundEffective postoperative pain control remains a challenge for patients undergoing cardiac surgery. Novel regional blocks may improve pain management for such patients and can shorten their length of stay in the hospital. To compare postoperative pain intensity in patients undergoing cardiac surgery with either erector spinae plane (ESP) block or combined ESP and pectoralis nerve (PECS) blocks.MethodsThis was a prospective, randomized, controlled, double-blinded study done in a tertiary hospital. Thirty patients undergoing mitral/tricuspid valve repair via mini-thoracotomy were included. Patients were randomly allocated to one of two groups: ESP or PECS + ESP group (1:1 randomization). Patients in both groups received a single-shot, ultrasound-guided ESP block. Participants in PECS + ESP group received additional PECS blocks. Each patient had to be extubated within 2 h from the end of the surgery. Pain was treated via a patient-controlled analgesia (PCA) pump. The primary outcome was the total oxycodone consumption via PCA during the first postoperative day. The secondary outcomes included pain intensity measured on the visual analog scale (VAS), patient satisfaction, Prince Henry Hospital Pain Score (PHHPS), and spirometry.ResultsPatients in the PECS + ESP group used significantly less oxycodone than those in the ESP group: median 12 [interquartile range (IQR): 6-16] mg vs. 20 [IQR: 18-29] mg (p = 0.0004). Moreover, pain intensity was significantly lower in the PECS + ESP group at each of the five measurements during the first postoperative day. Patients in the PECS + ESP group were more satisfied with pain management. No difference was noticed between both groups in PHHPS and spirometry.ConclusionsThe addition of PECS blocks to ESP reduced consumption of oxycodone via PCA, reduced pain intensity on the VAS, and increased patient satisfaction with pain management in patients undergoing mitral/tricuspid valve repair via mini-thoracotomy.Trial registrationThe study was registered on the 19th July 2018 (first posted) on the ClinicalTrials.gov identifier: NCT03592485.