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Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05682300
Acronym
CARE
Enrollment
1390
Registered
2023-01-12
Start date
2023-03-01
Completion date
2024-12-01
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Anesthesia

Keywords

peripheral nerve, regional anesthesia, complication

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.

Interventions

PROCEDUREperipheral 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.

Sponsors

Hospital del Rio Hortega
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
rate of complications of peripheral nerve blocks2 yearsThe main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain

Secondary

MeasureTime frameDescription
Etiology2 yearsExplain the etiology and mechanisms that contribute to nerve damage secondary to peripheral nerve blocks.
Number of Factors related2 yearsExplain the factors related to complications associated with fascial blocks.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026