Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery
NCT Number: NCT06567522
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Hip Fractures|Lumbar Erector Spinae Plane Block
Interventions: DRUG: Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%
Sponsor: Hospital Álvaro Cunqueiro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 180
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (CARE_PROVIDER)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-06-08
Completion Date: 2025-12-31
Locations: Hospital Álvaro Cunqueiro, Vigo, Pontevedra, 36312, Spain

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.

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., Collect data on post-surgery pain using the Visual Analogue Scale (VAS).The VAS scale ranges from 0 to 10, with 0 being no pain and 10 being maximum pain., 2 hours after surgery
Secondary Outcome Measures: 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, Consumption of morphine (mg), 12 hours postoperative|Percentage of patients with technical ease to perform the esp-l block, We will define the technical ease of the esp-l block from 1 to 3. 1 being good and when we are able to clearly distinguish anatomical structures in order to carry out the locoregional analgesia, 2 would be equivalent to regular, when these are sensed but not clearly defined structures and bad when we are not able to distinguish any anatomical structure that allows us to carry out the block., 48 hours postoperative|Patient satisfaction survey on pain management, We will classify patients into two groups according to their satisfaction with pain management in the postoperative period of hip surgery.

Being the group of patients who consider themselves satisfied with pain management when it meets their expectations and dissatisfied if the patients are discomforted with it., 48 hours postoperative|Describe de side effects of the lumbar ESP block and morphine, pruritus, nausea, vomiting, erythema, hypotension, 48 hours postoperative