Comparative Assessment of Effectiveness and Safety of L-ESPB Versus Absence of Locoregional Block in Hip Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Álvaro Cunqueiro
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Lumbar Erector Spinae Plane Block. L bupivacaína 0.25%
DrugUltrasound-guided ESP-L shall be carried out at the L3-14 level with 30 mL of levobupivacaine 0.25%
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: ESP-LExperimental treatment 1 intervention
Group B: No ESP-LNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
2 hours after surgerySecondary outcomes
1
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)
Time frame
12 hours postoperative2
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.
Time frame
48 hours postoperative3
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.
Time frame
48 hours postoperative4
Describe de side effects of the lumbar ESP block and morphine
pruritus, nausea, vomiting, erythema, hypotension
Time frame
48 hours postoperativeSponsors and contacts
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Source ClinicalTrials.gov