García-Reza Laura, Raposeiras Sergio, P Loureiro Javier, Pita-Romero Rafael, Amate Pena Juan Jose, Pereira Loureiro Miguel Angel
Division of Anaesthetics, Pain Medicine and Intensive Care, University Hospital Álvaro Cunqueiro, Vigo, Spain.
TALIONIS Research group, Information and Communications Technology Research Center, A Coruña University, A Coruña, Spain.
JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854.
Ultrasound-guided regional anesthesia in hip surgery has been shown to reduce the need for opioids and conventional analgesics, facilitate ambulation and early recovery, improve respiratory dynamics, and decrease the incidence of venous thrombosis and pneumonia. Lumbar erector spinae plane block (L-ESPB) has been proposed as a novel ultrasound-guided locoregional technique to relieve pain in hip surgery; however, the supporting evidence remains scarce.
This study aims to provide evidence on the role of L-ESPB in perioperative pain management during hip surgery. We hypothesize that patients receiving L-ESPB compared to those without block will have lower opioid consumption and less pain after hip surgery. The primary outcome is the difference in pain intensity, measured using the visual analog scale, at 2 hours postoperatively between the L-ESPB group and the control group. We will compare postoperative analgesic needs and opioid consumption in both groups, assess the technical ease of performing L-ESPB, and record any side effects in both treatment arms. Finally, we will evaluate the level of patient satisfaction.
This is a pragmatic, single-center, parallel-group randomized controlled trial. After patients provide informed consent, they will be randomly assigned in a 1:1 ratio to receive either ultrasound-guided L-ESPB or conventional intravenous analgesia. A total of 180 patients (n=90, 50% in each group) will be enrolled. Data analysis will be performed using SPSS software.
This clinical trial was approved by the European Medicines Agency on May 27, 2024, following approval by the local ethics committee earlier that month. Patient recruitment took place between June 2024 and May 2025. Statistical analysis is currently ongoing, and final results are expected to be submitted for publication in early 2026.
This clinical trial will enable us to assess the analgesic effectiveness of L-ESPB in hip surgery. We will also evaluate its safety and potential adverse effects compared with conventional analgesia and opioid consumption.
ClinicalTrials.gov NCT06567522; https://www.clinicaltrials.gov/study/NCT06567522.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/75854.
超声引导下的区域麻醉应用于髋关节手术已被证明可减少对阿片类药物和传统镇痛药的需求，促进患者行走和早期康复，改善呼吸动力学，并降低静脉血栓形成和肺炎的发生率。腰椎竖脊肌平面阻滞（L-ESPB）已被提出作为一种新型的超声引导下局部区域技术用于缓解髋关节手术中的疼痛；然而，支持证据仍然匮乏。
本研究旨在为L-ESPB在髋关节手术围手术期疼痛管理中的作用提供证据。我们假设与未接受阻滞的患者相比，接受L-ESPB的患者在髋关节手术后阿片类药物的消耗量更低且疼痛更轻。主要结局是L-ESPB组和对照组术后2小时使用视觉模拟量表测量的疼痛强度差异。我们将比较两组术后的镇痛需求和阿片类药物消耗量，评估实施L-ESPB的技术难易程度，并记录两个治疗组的任何副作用。最后，我们将评估患者满意度水平。
这是一项务实的单中心平行组随机对照试验。患者提供知情同意后，将按1:1的比例随机分配接受超声引导下的L-ESPB或传统静脉镇痛。总共将招募180名患者（每组n = 90，各占50%）。将使用SPSS软件进行数据分析。
该临床试验于2024年5月27日获得欧洲药品管理局批准，当月早些时候已获得当地伦理委员会批准。患者招募于2024年6月至2025年5月期间进行。目前正在进行统计分析，最终结果预计将于2026年初提交发表。
这项临床试验将使我们能够评估L-ESPB在髋关节手术中的镇痛效果。我们还将评估其与传统镇痛和阿片类药物消耗相比的安全性和潜在不良反应。
ClinicalTrials.gov NCT06567522；https://www.clinicaltrials.gov/study/NCT06567522。
国际注册报告标识符（IRRID）：DERR1-10.2196/75854。
