Analgesic efficacy of a regional tecnique (erector spinae plane block) in lumbar spine surgery

Analgesic efficacy of erector spinae plane block in lumbar spine surgery: a prospective, randomized and double blind study. - BEE trial

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-000135-47-ES

Enrollment

100

Registered

2021-08-31

Start date

2021-11-02

Completion date

Unknown

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The analgesic efficacy of erector spinae plane block in lumbar spine surgery. Infiltration of local anesthetic in this plane may lower postoperative pain.

Interventions

Trade Name: Levobupivacaine Pharmaceutical Form: Solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients older than 18 years - American society Status classification (ASA) I-III - Elective spine surgery up to 4 spaces. - Primary surgery and reinterventions Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: - Urgent surgery - Infection in site of surgery - Allergy to local anesthetics, opioids u other analgesics used in the trial. - Contraindications for regional technique - Patient refusal - Absence of informed consent - Surgical complication that may interfer with adequate pain assessment

Design outcomes

Primary

Measure	Time frame
Main Objective: To campare 24h morphine consumption between patients that received erector spinae plane block and patients that did not receive any regional technique.;Secondary Objective: To compare between the groups: - Morphine consumption throughout hospital stay - VAS scores - Time to first mobilisation - Time to firt sitting - Time to first standing - Hospital stay;Primary end point(s): First 24h morphine consumption;Timepoint(s) of evaluation of this end point: 24h	—

Measure

Time frame

Main Objective: To campare 24h morphine consumption between patients that received erector spinae plane block and patients that did not receive any regional technique.;Secondary Objective: To compare between the groups: - Morphine consumption throughout hospital stay - VAS scores - Time to first mobilisation - Time to firt sitting - Time to first standing - Hospital stay;Primary end point(s): First 24h morphine consumption;Timepoint(s) of evaluation of this end point: 24h

—

Secondary

Measure	Time frame
Secondary end point(s): To compare between the groups: - Morphine consumption throughout hospital stay - VAS scores - Time to first mobilisation - Time to firt sitting - Time to first standing - Hospital stay;Timepoint(s) of evaluation of this end point: During hospital stay	—

Countries

Spain

Contacts

Public ContactDepartment of Anesthesiology

Hospital Universitario Fundación Alcorcón

dianarocio.zamudio@salud.madrid.org

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026