Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

NCT ID: NCT05682300

Last Updated: 2025-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2024-12-01

Brief Summary

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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

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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.

Conditions

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Complication of Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient under regional anesthesia

patients who recieve peripheral nerve blocks as analgesic technique

peripheral nerve block

Intervention Type 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.

Interventions

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peripheral nerve block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital del Rio Hortega

OTHER

Sponsor Role lead

Responsible Party

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María Teresa Fernandez

Fernandez,Maria Teresa, MD, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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María T Fernandez

Role: STUDY_CHAIR

Hospital del Rio Hortega

Locations

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Judith Andres

Valladolid, Castille and León, Spain

Site Status

Countries

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Spain

Other Identifiers

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22-EO069

Identifier Type: -

Identifier Source: org_study_id

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