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Clinical Trials/NCT05682300
NCT05682300
Completed
Not Applicable

"Incidence and Etiology of Complications Associated With Regional Anesthesia of Peripheral Nerves: a Prospective Study"

Hospital del Rio Hortega1 site in 1 country1,390 target enrollmentMarch 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Complication of Anesthesia
Sponsor
Hospital del Rio Hortega
Enrollment
1390
Locations
1
Primary Endpoint
rate of complications of peripheral nerve blocks
Status
Completed
Last Updated
last year

Overview

Brief Summary

Procedures performed under regional anesthesia, especially peripheral nerve blocks (PNB) have increased markedly in recent decades. However, like any technical procedure, these techniques carry an implicit risk of complications.

The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain.

Detailed Description

Introduction. The number of procedures performed under regional anesthesia, especially peripheral nerve blocks (BNP) have increased notably in recent decades due to the improvement in pain control and the quality of post-anesthetic recovery that they provide. However, like any technical procedure, these techniques carry an implicit risk of complications. Purpose. The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain. Material and methods. The postoperative results regarding the complications of regional anesthesia of peripheral nerves will be evaluated in a national audit of a prospective observational cohort in which hospitals at the state level in which these regional techniques are routinely performed will participate. A minimum sample size has been calculated on a population of 100,000 patients and a 95% confidence interval of 1,390, assuming a complication rate of 0.2% based on previous publications. Inclusion criteria correspond to patients older than 18 years scheduled for surgery with a peripheral regional anesthesia technique as the basis of anesthesia or as part of a multimodal analgesic strategy.

Registry
clinicaltrials.gov
Start Date
March 1, 2023
End Date
December 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Hospital del Rio Hortega
Responsible Party
Principal Investigator
Principal Investigator

María Teresa Fernandez

Fernandez,Maria Teresa, MD, Principal investigator

Hospital del Rio Hortega

Eligibility Criteria

Inclusion Criteria

  • Age: 18-65 years
  • ASA I- IV
  • Being scheduled for surgery with peripheral and/or fascial nerve blocks as the basis of anesthesia or as part of a multimodal analgesic strategy.

Exclusion Criteria

  • Refusal of the patient to participate in the study
  • Contraindication for performing the regional technique (People with infections in the area of the skin where the puncture must be performed, allergy to anesthetics, severe blood coagulation disorders, previous nerve damage).
  • Motor or sensory deficit prior to surgery in the metameric area susceptible to performing the block.

Outcomes

Primary Outcomes

rate of complications of peripheral nerve blocks

Time Frame: 2 years

The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain

Secondary Outcomes

  • Etiology(2 years)
  • Number of Factors related(2 years)

Study Sites (1)

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