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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-08

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Fractures Lumbar Erector Spinae Plane Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pragmatic single-centre parallel group randomized clinical trial

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Pragmatic randomized low interventional single-centre parallel non blinded design with blinded assessment of the objectives.

Study Groups

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ESP-L

After hip fracture surgery ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%

Group Type EXPERIMENTAL

Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%

Intervention Type DRUG

Ultrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%

No ESP-L

Conventional intravenous analgesia after hip fracture surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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%

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No