NCT06567522 Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery
| NCT ID | NCT06567522 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital Álvaro Cunqueiro |
| Condition | Hip Fractures |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-06-08 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 180 participants in total. It began in 2024-06-08 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Laura García Reza
PRINCIPAL INVESTIGATOR
Hospital Álvaro Cunqueiro
Frequently Asked Questions
Who can join the NCT06567522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hip Fractures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06567522 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06567522 currently recruiting?
Yes, NCT06567522 is actively recruiting participants. Contact the research team at laura.garcia.reza@sergas.es for enrollment information.
Where is the NCT06567522 trial being conducted?
This trial is being conducted at Vigo, Spain.
Who is sponsoring the NCT06567522 clinical trial?
NCT06567522 is sponsored by Hospital Álvaro Cunqueiro. The principal investigator is Laura García Reza at Hospital Álvaro Cunqueiro. The trial plans to enroll 180 participants.