Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks

NCT05682300 | Completed DMC

• 1 other identifier: 22-EO069
• Study Type: observational
• Target: 1,390
• Locations: 1 country
• Sites: 1

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.

Conditions

Complication of Anesthesia

Keywords

peripheral nerve; regional anesthesia; complication

Outcome Measures

Primary Outcomes (1)

• rate of complications of peripheral nerve blocks

  The main objective of the study is to determine the incidence of complications associated with peripheral nerve blocks and fascial blocks in Spain

  2 years

Secondary Outcomes (2)

• Etiology

  2 years

• Number of Factors related

  2 years

Study Arms (1)

Patient under regional anesthesia

patients who recieve peripheral nerve blocks as analgesic technique

Procedure: peripheral nerve block

Interventions

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.

Patient under regional anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out in all those hospitals nationwide that agree to be part of it. Each participating center will recruit patients for one year or until the estimated sample size is achieved. After signing the informed consent by the patient, specific to 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital del Rio Hortega: lead

Study Sites (1)

Judith Andres

Valladolid, Castille and León, 47008, Spain

Location

Study Officials

• María T Fernandez

  Hospital del Rio Hortega

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fernandez,Maria Teresa, MD, Principal investigator

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 12, 2023
• Study Start: March 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

ES (1)