Clinical trial NCT06567522: Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery
Official title: Comparative Assessment of Effectiveness and Safety of Lumbar Erector Spinae Plane Block (L-ESPB) Versus Absence of Locoregional Block in Hip Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Hip Fractures
Lumbar Erector Spinae Plane Block
Lead sponsor: Hospital Álvaro Cunqueiro
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic single-centre parallel group randomized clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Primary outcomes:
measure: 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.
timeFrame: 2 hours after surgery
Secondary outcomes:
measure: 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
timeFrame: 12 hours postoperative
measure: Percentage of patients with technical ease to perform the esp-l block
timeFrame: 48 hours postoperative
measure: Patient satisfaction survey on pain management
timeFrame: 48 hours postoperative
measure: Describe de side effects of the lumbar ESP block and morphine
timeFrame: 48 hours postoperative
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Hospital Álvaro Cunqueiro
name: Laura García Reza
role: PRINCIPAL_INVESTIGATOR
References: