Effect of rectus sheath anaesthesia versus thoracic epidural analgesia on postoperative recovery quality after elective open abdominal surgery in a French regional hospital: the study protocol of a randomised controlled QoR-RECT-CATH trial

Abstract

Introduction: Enhanced recovery after surgery (ERAS) protocols increase patient well-being while significantly reducing mortality, costs and length-of-stay after surgery. A key component is multimodal analgesia that prevents postoperative pain and facilitates early refeeding and mobilisation. Thoracic epidural analgesia (TEA) was long the gold standard for locoregional anaesthesia in anterior abdominal wall surgery. However, newer wall-block techniques such as rectus-sheath block (RSB) may be preferable because they are less invasive and may provide equivalent analgesia with fewer side effects. Since the evidence base remains limited, the Quality Of Recovery enhanced by REctus sheat CATHeter (QoR-RECT-CATH) randomised controlled trial (RCT) was designed to assess whether RSB elicits better postoperative rehabilitation than TEA after laparotomy.

Methods and analysis: This open-label parallel-arm 1:1-allocated RCT will determine whether RSB is superior to TEA in 110 patients undergoing scheduled midline laparotomy in terms of postoperative rehabilitation quality. The setting is a regional French hospital that provides opioid-free anaesthesia for all laparotomies within an ERAS programme. Recruited patients will be ≥18 years, scheduled to undergo laparotomy, have American Society of Anesthesiologists (ASA) score 1-4 and lack contraindications to ropivacaine/TEA. TEA-allocated patients will receive an epidural catheter before surgery while RSB-allocated patients will receive rectus sheath catheters after surgery. All other pre/peri/postoperative procedures will be identical, including multimodal postoperative analgesia provided according to our standard of care. Primary objective is a change in total Quality-of-Recovery-15 French-language (QoR-15F) score on postoperative day (POD) 2 relative to baseline. QoR-15F is a patient-reported outcome measure that is commonly used to measure ERAS outcomes. The 15 secondary objectives include postoperative pain scores, opioid consumption, functional recovery measures and adverse events.

Ethics and dissemination: The French Ethics Committee (Sud-Ouest et Outre-Mer I Ethical Committee) gave approval. Subjects are recruited after providing written consent after receiving the information provided by the investigator. The results of this study will be made public through peer-reviewed publication and, if possible, conference publications.

Trial registration number: NCT04985695.

Keywords: ANAESTHETICS; Adult anaesthesia; Pain management.

Figure 1

CONSORT (Consolidated Standards of Reporting Trials) flow diagram. PCA, patient-controlled analgesia; POD, postoperative day; QoR-15F, French version of Quality-of-Recovery 15; TEA, thoracic epidural analgesia.