Comparison Between 2 Techniques for Lumbar-ESPB

NCT07104097 | Not Yet Recruiting

• 1 other identifier: 0018028/25
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Surgery

Keywords

erector spinae plane block; hip surgery; sensory block; motor block; local anesthetic

Outcome Measures

Primary Outcomes (1)

• sensory block

  incidence of reduced or abolished cold sensation on the skin in the territory of lumbar plexus (anterior, medial and lateral thigh)

  24 hours

Secondary Outcomes (6)

• motor block

  24 hours

• postoperative pain

  48 hours

• morphine consumption

  24 hours

• quality of recovery

  48 hours

• complications

  48 hours

Study Arms (2)

superficial ESPB

ACTIVE COMPARATOR

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

Procedure: spinal anesthesia; Procedure: superficial erector spinal plane block (ESPB); Drug: Dexamethasone; Drug: Ibuprofen 400 mg; Drug: Paracetamol; Drug: Morphine

deep ESPB

EXPERIMENTAL

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

Procedure: spinal anesthesia; Procedure: deep (inter laminar) erector spinal plane block (ESPB); Drug: Dexamethasone; Drug: Ibuprofen 400 mg; Drug: Paracetamol; Drug: Morphine

Interventions

spinal anesthesia PROCEDURE

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

deep ESPB; superficial ESPB

superficial erector spinal plane block (ESPB) 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

superficial ESPB

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

deep ESPB

Dexamethasone DRUG

8 mg iv preoperatively

deep ESPB; superficial ESPB

Ibuprofen 400 mg DRUG

preoperatively and postoperatively (every 8 hours)

deep ESPB; superficial ESPB

Paracetamol DRUG

1000 mg preoperatively and postoperatively (every 8 hours)

deep ESPB; superficial ESPB

Morphine DRUG

Patient Controlled Analgesia

deep ESPB; superficial ESPB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary total hip replacement
• informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Papa Giovanni XXIII Hospital: lead

Study Sites (1)

Aast Papa Giovanni Xxiii

Bergamo, 24127, Italy

Location

MeSH Terms

Interventions

Anesthesia, Spinal; Dexamethasone; Ibuprofen; Acetaminophen; Morphine

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons

Central Study Contacts

Dario Bugada

CONTACT

+393405230454; dariobugada@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor will not be aware of the technique used in the OR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: randomized trial, single blind

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: August 11, 2025
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: August 11, 2025

Record last verified: 2025-08

Locations

IT (1)