Study Results
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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NOT_YET_RECRUITING
NA
44 participants
INTERVENTIONAL
2025-08-11
2026-06-20
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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superficial ESPB
Injection on top of L3 transverse process, plane between bone and erector spinae muscle
spinal anesthesia
spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml
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
Dexamethasone
8 mg iv preoperatively
Ibuprofen 400 mg
preoperatively and postoperatively (every 8 hours)
Paracetamol
1000 mg preoperatively and postoperatively (every 8 hours)
Morphine
Patient Controlled Analgesia
deep ESPB
Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles
spinal anesthesia
spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml
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
Dexamethasone
8 mg iv preoperatively
Ibuprofen 400 mg
preoperatively and postoperatively (every 8 hours)
Paracetamol
1000 mg preoperatively and postoperatively (every 8 hours)
Morphine
Patient Controlled Analgesia
Interventions
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spinal anesthesia
spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml
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
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
Dexamethasone
8 mg iv preoperatively
Ibuprofen 400 mg
preoperatively and postoperatively (every 8 hours)
Paracetamol
1000 mg preoperatively and postoperatively (every 8 hours)
Morphine
Patient Controlled Analgesia
Eligibility Criteria
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Inclusion Criteria
* informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Papa Giovanni XXIII Hospital
OTHER
Responsible Party
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Dario Bugada
MD
Locations
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Aast Papa Giovanni Xxiii
Bergamo, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0018028/25
Identifier Type: -
Identifier Source: org_study_id
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