Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 11, 2025
Date Accepted: Jul 4, 2025
Comparative assessment of effectiveness and safety of Lumbar Erector Spinae Plane Block (L-ESPB) versus absence of locoregional block in hip surgery: study protocol for a randomized controlled trial
ABSTRACT
Background:
Hip surgery accounts for a high percentage of both emergency and elective surgical procedures in hospitals. Regardless of surgery being prescribed to treat a fracture or coxarthrosis, patients are usually elderly with multiple associated comorbidities; there is a tendency to undertreat pain for fear of the side effects and pharmacological interactions of conventional analgesic drugs. Ultrasound-guided regional anesthesia applied in orthopedic and trauma surgery has been shown to reduce the doses of opioids and conventional analgesics, to ease deambulation and early recovery, to improve respiratory dynamics and to reduce vein thrombosis and pneumonias.
Objective:
Our study aims to verify whether L-ESP block is effective in the hip and proximal femur surgeries and allows to lower the dosage of opioids in these patients. Our primary objective is to compare the analgesic effectiveness and safety of lumbar ESP block versus absence of block after hip and proximal femur surgeries by means of the VAS scale with pain reduction of at least 1 point in the first two hours after surgery. We shall compare the analgesic postoperative needs after performing L-ESP block versus a control group of patients having undergone hip or proximal femur surgeries and the postoperative consumption of opioids in both groups; also assess and compare the technical ease of the perform (L-ESP block) and the side effects in both lines of treatment. Finally, we shall assess the level of satisfaction of the patients.
Methods:
A pragmatic single-centre parallel group randomized clinical trial. Upon signing the informed consent and after the surgery, a systematic randomization shall be carried out. There will be two groups of patients (a group on which ultrasound-guided L-ESP and a control group which shall be handled with conventional intravenous analgesia). A total of 180 patients, 90 in each group. The analysis shall be carried out using the IBM SPSS software platform.
Results:
The clinical trial is currently ongoing, with an expected recruitment end date of June 2024. The recruitment period will be 18 months.
Conclusions:
This clinical trial will allow us to assess the effectiveness of the L-ESP block in hip surgery. Additionally, we will also assess its safety and potential adverse effects as against conventional analgesia and consumption of opioids. Because of the complex innervation of the hip joint, we believe that ESP-L block will be useful to manage pain in patients after hip surgery. Application of this kind of multimodal analgesia (associating locoregional blocks) will enable us to approach pain more comprehensively to achieve a faster rehabilitation and recovery of the hip surgery patient. Clinical Trial: Clinical trial registration: ID: NCT06567522. EU CT 2024-511528-15-00 (ClinicalTrials.gov). Committee on Ethics for Drug Research in Galicia (CEIm-G): May, 2024
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