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Clinical Trials/EUCTR2020-000135-47-ES
EUCTR2020-000135-47-ES
Active, not recruiting
Phase 1

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

Hospital Universitario Fundación Alcorcón0 sites100 target enrollmentAugust 31, 2021
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DrugsLevobupivacaine

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Hospital Universitario Fundación Alcorcón
Enrollment
100
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 31, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Hospital Universitario Fundación Alcorcón

Eligibility 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

  • •\- 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

Outcomes

Primary Outcomes

Not specified

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