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Recruiting NCT06567522

Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery

Phase IV Interventional Hip Fractures Lumbar Erector Spinae Plane Block

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%.
Who it may be relevant to
Registry conditions: Hip Fractures, Lumbar Erector Spinae Plane Block. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Assessment of Effectiveness and Safety of Lumbar Erector Spinae Plane Block (L-ESPB) Versus Absence of Locoregional Block in Hip Surgery

Overview

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. When faced with this patient profile, 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. 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.

Interventions

  • Drug Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%
    Ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%

Primary outcome measures

  • 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. [Time frame: 2 hours after surgery]
Secondary outcome measures (4)
  • 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 [Time frame: 12 hours postoperative]
  • Percentage of patients with technical ease to perform the esp-l block [Time frame: 48 hours postoperative]
  • Patient satisfaction survey on pain management [Time frame: 48 hours postoperative]
  • Describe de side effects of the lumbar ESP block and morphine [Time frame: 48 hours postoperative]

Eligibility criteria

Inclusion criteria

  • Both sexes over 18 years of age having undergone hip surgery
  • ASA I-III (classification system used by the American Society of Anesthesiologists where I is low anesthetic risk and IV is high risk)
  • Capacity to comprehend the principles of pain assessment using the VAS visual analogue scale
  • Previously signed an informed consent.

Exclusion criteria

  • Contraindications for the technique and/or the drugs used in this context
  • Technical inability to perform the block
  • Severe cognitive impairment or prior mental disabilities described in their medical records
  • Patients already included in other clinical trials.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Spain · 1 center
  • Hospital Álvaro Cunqueiro — Vigo

Publications

  • Garcia-Reza L, Raposeiras S, P Loureiro J, Pita-Romero R, Amate Pena JJ, Pereira Loureiro MA. Effectiveness and Safety of Lumbar Erector Spinae Plane Block Versus No Locoregional Block in Hip Surgery: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Sep 15;14:e75854. doi: 10.2196/75854. PMID 40953436

Identifiers

NCT: NCT06567522 · ESPL - MORFINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗