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

Phase 1

• Conditions: The analgesic efficacy of erector spinae plane block in lumbar spine surgery. Infiltration of local anesthetic in this plane may lower postoperative pain.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2020-000135-47-ES
• Lead Sponsor: Hospital Universitario Fundación Alcorcón

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-08-31
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified