Comparison Between 2 Techniques for Lumbar-ESPB

NCT ID: NCT07104097

Last Updated: 2025-08-11

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2026-06-20

Brief Summary

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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.

Detailed Description

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Conditions

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Hip Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomized trial, single blind
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
outcome assessor will not be aware of the technique used in the OR

Study Groups

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superficial ESPB

Injection on top of L3 transverse process, plane between bone and erector spinae muscle

Group Type ACTIVE_COMPARATOR

spinal anesthesia

Intervention Type PROCEDURE

spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml

superficial erector spinal plane block (ESPB)

Intervention Type PROCEDURE

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

Intervention Type DRUG

8 mg iv preoperatively

Ibuprofen 400 mg

Intervention Type DRUG

preoperatively and postoperatively (every 8 hours)

Paracetamol

Intervention Type DRUG

1000 mg preoperatively and postoperatively (every 8 hours)

Morphine

Intervention Type DRUG

Patient Controlled Analgesia

deep ESPB

Injection BETWEEN L3 and L4 transverse process, fascial plane between erector spinae muscle AND the deep muscles

Group Type EXPERIMENTAL

spinal anesthesia

Intervention Type PROCEDURE

spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml

deep (inter laminar) erector spinal plane block (ESPB)

Intervention Type PROCEDURE

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

Intervention Type DRUG

8 mg iv preoperatively

Ibuprofen 400 mg

Intervention Type DRUG

preoperatively and postoperatively (every 8 hours)

Paracetamol

Intervention Type DRUG

1000 mg preoperatively and postoperatively (every 8 hours)

Morphine

Intervention Type DRUG

Patient Controlled Analgesia

Interventions

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spinal anesthesia

spinal anesthesia at L3-L4 plain bupivacaine 0.5% 2.2 ml

Intervention Type 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

Intervention Type 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

Intervention Type PROCEDURE

Dexamethasone

8 mg iv preoperatively

Intervention Type DRUG

Ibuprofen 400 mg

preoperatively and postoperatively (every 8 hours)

Intervention Type DRUG

Paracetamol

1000 mg preoperatively and postoperatively (every 8 hours)

Intervention Type DRUG

Morphine

Patient Controlled Analgesia

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Papa Giovanni XXIII Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dario Bugada

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aast Papa Giovanni Xxiii

Bergamo, , Italy

Site Status

Countries

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Italy

Central Contacts

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Dario Bugada

Role: CONTACT

+393405230454

Facility Contacts

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DARIO BUGADA, MD

Role: primary

00390352675113

Other Identifiers

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0018028/25

Identifier Type: -

Identifier Source: org_study_id

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