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OpenTrials
Completed

NCT Number: NCT05682300

Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Judith Andres

Valladolid, Castille and León, 47008, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Peripheral nerve block

Procedure

After signing the informed consent by the patient, specific for this observational study, the peripheral regional anesthesia technique will be performed following the usual practice of the anesthesiologist responsible for the surgery. Under standard monitoring and taking into account the necessary aseptic measures, either peripheral nerve blocks (for surgeries involving extremities) or fascial blocks (for surgeries involving the chest wall, abdomen, or spine) will be performed.

Primary outcomes

  1. 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

  1. Etiology

    Time frame: 2 years

    Explain the etiology and mechanisms that contribute to nerve damage secondary to peripheral nerve blocks.

  2. Number of Factors related

    Time frame: 2 years

    Explain the factors related to complications associated with fascial blocks.

Sponsors and collaborators

Lead sponsor

Hospital del Rio Hortega

Other

Registry information

Official study title

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

Acronym: CARE

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 12, 2023
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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