Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

Completed

• Conditions: Complication of Anesthesia
• Interventions: Procedure: peripheral nerve block

• Registration Number: NCT05682300
• Lead Sponsor: Hospital del Rio Hortega

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.

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-27
• Study First Posted: 2023-01-12
• Study Start: 2023-03-01
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1390

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient under regional anesthesia	peripheral nerve block	patients who recieve peripheral nerve blocks as analgesic technique

Primary Outcome Measures

Name	Time	Method
rate of complications of peripheral nerve blocks	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 Outcome Measures

Name	Time	Method
Etiology	2 years	Explain the etiology and mechanisms that contribute to nerve damage secondary to peripheral nerve blocks.
Number of Factors related	2 years	Explain the factors related to complications associated with fascial blocks.

Trial Locations

Locations (1)

Judith Andres; 🇪🇸 Valladolid, Castilla Y León, Spain