Comparison Between 2 Techniques for Lumbar-ESPB
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: spinal anesthesia, superficial erector spinal plane block (ESPB), deep (inter laminar) erector spinal plane block (ESPB), Dexamethasone.
- Who it may be relevant to
- Registry conditions: Hip Surgery. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Regional Anesthesia in Hip Arthroplasty- Comparison Between Two Techniques for Erector Spinae Plane Block
Overview
Diffusion of local anesthetics after a lumbar ESPB within fascial planes towards nerve structures is a matter of debate. The main objective of the study is to compare the incidence of sensory block between two techniques of needle placement (superficial or translaminar) during lumbar ESPB block. Patients are treated with lumbar ESPB (randomized to superficial or translaminar), spinal anesthesia and multimodal analgesia. The primary endpoint will be the incidence of numbness/reduced skin sensitivity to cold (ice test) in the area innervated by the lumbar plexus. Secondary outcomes are pain and analgesic's consumption, motor block, quality of recovery and discharge ability.
Interventions
- Procedure spinal anesthesia
spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml - Procedure superficial erector spinal plane block (ESPB)
Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 on top of L3 transverse process, between bone and erector spinae muscle - Procedure deep (inter laminar) erector spinal plane block (ESPB)
Lidocaine 1% + ropivacaine 0.25% 30 ml with adrenaline 1:200.000 between L3 and L4 transverse process, between erector spinae muscle and deep muscles - Drug Dexamethasone
8 mg iv preoperatively - Drug Ibuprofen 400 mg
preoperatively and postoperatively (every 8 hours) - Drug Paracetamol
1000 mg preoperatively and postoperatively (every 8 hours) - Drug Morphine
Patient Controlled Analgesia
Primary outcome measures
- sensory block [Time frame: 24 hours]
Secondary outcome measures (6)
- motor block [Time frame: 24 hours]
- postoperative pain [Time frame: 48 hours]
- morphine consumption [Time frame: 24 hours]
- quality of recovery [Time frame: 48 hours]
- complications [Time frame: 48 hours]
- discharge ability [Time frame: 48 hours]
Eligibility criteria
Inclusion criteria
- primary total hip replacement
- informed consent
Exclusion criteria
- allergies to study drugs
- spinal anesthesia contraindicated
- kidney failure (GFR<30)
- epilepsy, psychiatric disease, neurologic deficits
- revision surgery
- neuropathies in the lumbar area (tingling, hypoestesia, numbness, motor deficit)
- no informed consent
- pregnancy
- alcohol/opioid abuse
- emergency surgery/intensive care
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Aast Papa Giovanni Xxiii — Bergamo
Identifiers
NCT: NCT07104097 · 0018028/25