Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks
NCT ID: NCT05682300
Last Updated: 2025-03-14
Study Results
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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COMPLETED
1390 participants
OBSERVATIONAL
2023-03-01
2024-12-01
Brief Summary
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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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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient under regional anesthesia
patients who recieve peripheral nerve blocks as analgesic technique
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Hospital del Rio Hortega
OTHER
Responsible Party
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María Teresa Fernandez
Fernandez,Maria Teresa, MD, 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
Countries
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Other Identifiers
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22-EO069
Identifier Type: -
Identifier Source: org_study_id
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