JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854.
ABSTRACT
BACKGROUND: 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.
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
TRIAL REGISTRATION: ClinicalTrials.gov NCT06567522; https://www.clinicaltrials.gov/study/NCT06567522.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/75854.
PMID:40953436 | DOI:10.2196/75854
