Complication of AnesthesiaCARENCT05682300
Incidence and Etiology of Complications Associated With Peripheral Nerves Blocks
An observational study of Complication of Anesthesia, run by Hospital del Rio Hortega at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complication of Anesthesia
- What is being tested?
- peripheral nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 1,390 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 1 Dec 2024
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Incidence and Etiology of Complications Associated With Regional Anesthesia of Peripheral Nerves: a Prospective Study"
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.
Read the 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.
- Conditions
- Complication of Anesthesia
- Being tested
- peripheral nerve block
- Keywords
- peripheral nerve, regional anesthesia, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral nerve blockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient under regional anesthesia | patients who recieve peripheral nerve blocks as analgesic technique Receives: Procedure: peripheral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (2)
Etiology
Explain the etiology and mechanisms that contribute to nerve damage secondary to peripheral nerve blocks.
Measured: 2 years
Number of Factors related
Explain the factors related to complications associated with fascial blocks.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start1 Mar 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complication of AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,390 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Hospital del Rio Hortega
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Teresa Fernandez, Hospital del Rio Hortega
- Investigators
- María T Fernandez, Study chair, Hospital del Rio Hortega
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682300
- Sponsor's protocol ID
- 22-EO069
- Acronym
- CARE
- Status last verified
- Mar 2025
- First submitted
- 19 Dec 2022
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Incidence and Etiology of Complications Associated With Regional Anesthesia of Peripheral Nerves: a Prospective Study"
- ClinicalTrials.gov ID
- NCT05682300
- Acronym / sponsor ID
- CARE / 22-EO069
- Conditions
- Complication of Anesthesia
- Keywords
- peripheral nerve, regional anesthesia, complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,390 participants (actual)
- Lead sponsor
- Hospital del Rio HortegaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient under regional anesthesia | – | Procedure: peripheral nerve blockpatients who recieve peripheral nerve blocks as analgesic technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral nerve blockAfter 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. | Procedure or surgery | Patient under regional anesthesia |
Primary outcome
rate of complications of peripheral nerve blocks
Time frame: 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
2 secondary outcomes
Etiology
Time frame: 2 years
Number of Factors related
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María T Fernandez study chair
Hospital del Rio Hortega
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Anesthesia, run by Hospital del Rio Hortega at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of complications of peripheral nerve blocks (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.