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Clinical Trials/2024-511528-15-00
2024-511528-15-00
Completed
Phase 4

Comparative analysis of the effectiveness and security of the blockade Erectus Spinae Plane Lumbar (ESP-L) versus the absence of locoregional block in hip surgery

Asociacion Gallega De Anestesiologia Reanimacion Y Dolor1 site in 1 country170 target enrollmentStarted: May 27, 2024Last updated:

Overview

Phase
Phase 4
Status
Completed
Sponsor
Asociacion Gallega De Anestesiologia Reanimacion Y Dolor
Enrollment
170
Locations
1
Primary Endpoint
To compare the analgesic efficacy and safety of lumbar ESP block versus the absence of blockade in the postoperative period of hip and proximal femur surgery through the VAS scale with pain reduction of at least 1 point after two hours postoperative.

Overview

Brief Summary

Compare the analgesic efficacy of lumbar ESP block versus no block locoregional in patients undergoing hip and proximal femur surgery through the VAS scale with pain reduction of at least 1 point after two hours postoperative.

Eligibility Criteria

Ages
18 years to 65+ years (18-64 Years, 65+ Years)
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients undergoing hip surgery. - Patients over 18 years of age. - Both genders. -ASA I-III. Classification system used by the American Society of Anesthesiologists where I is low anesthetic risk and IV is high risk . - Understanding the principles of pain assessment using a visual scale analogue EVA - Signature of consent

Exclusion Criteria

  • Patients with contraindications for performing the technique - Technical inability to perform either of the two blocks described - Significant cognitive impairment or previous mental disability described in history clinic - Patients included in another clinical trial

Outcomes

Primary Outcomes

To compare the analgesic efficacy and safety of lumbar ESP block versus the absence of blockade in the postoperative period of hip and proximal femur surgery through the VAS scale with pain reduction of at least 1 point after two hours postoperative.

To compare the analgesic efficacy and safety of lumbar ESP block versus the absence of blockade in the postoperative period of hip and proximal femur surgery through the VAS scale with pain reduction of at least 1 point after two hours postoperative.

Secondary Outcomes

  • - Compare postoperative analgesic needs after performing the block ESP-L versus control group of patients undergoing hip or femur surgery proximal - Compare postoperative opioid consumption in the two groups. - Assess and compare the technical ease of the intervention (ESP-L block) - Compare the side effects in the two lines of treatment - Assess the level of patient satisfaction

Investigators

Sponsor
Asociacion Gallega De Anestesiologia Reanimacion Y Dolor
Sponsor Class
Patient organisation/association
Responsible Party
Principal Investigator
Principal Investigator

Laura

Scientific

Asociacion Gallega De Anestesiologia Reanimacion Y Dolor

Study Sites (1)

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