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Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks (CARE)

H

Hospital del Rio Hortega

Status

Completed

Conditions

Complication of Anesthesia

Treatments

Procedure: peripheral nerve block

Study type

Observational

Funder types

Other

Identifiers

NCT05682300
22-EO069

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,390 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

1,390 participants in 1 patient group

Patient under regional anesthesia
Description:
patients who recieve peripheral nerve blocks as analgesic technique
Treatment:
Procedure: peripheral nerve block

Trial contacts and locations

1

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Central trial contact

Cesar Aldecoa; María Teresa F Fernandez Martín, MD

Data sourced from clinicaltrials.gov

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