A Retrospective Clinical Registry of Peripheral Nerve Block

August 8, 2022 updated by: Instituto de Investigación Sanitaria Aragón

A Retrospective Clinical Registry of Peripheral Nerve Block: Current Practice and Complications

Locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. They provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay.

The primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division.

This is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Locorregional anaesthesia have been increased its role in different kind of surgeries, alone or combined with general anesthesia. Due to ultrasound, peripheral nerve blocks have been increased their importance in locoregional anaesthesia. They provide excellent intraoperative and postoperative analgesia, decreasing the need for intravenous opioids which increase postoperative nausea and vomiting which may prolong hospital stay.

However, peripheral nerve blocks may be associated with postoperative complications, especially neurological ones. Classically, interscalene brachial plexus block produced a 100% incidence of phrenic nerve paralysis with resultant pulmonary compromise. Little literature has published a following of complications.

The primary study objective is to analyze retrospectively the use of peripheral nerve blocks in the current practice of a specialized regional anaesthesia division. The secondary objectives are assessed the patients characteristics of our sample, local anaesthetic dose used, the peripheral nerve block operator, the nerve location technique, the surgery and the complication rate after peripheral nerve block.

This is an observational, retrospective and unicenter study. 1346 patients scheduled for the surgery needed a peripheral nerve block were enrolled.

Study Type

Observational

Enrollment (Actual)

13816

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50012
        • Hospital Universitario Miguel Servet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants were recruited from the current practice of the Anesthesia Department (Division of Regional Anesthesia) at the Hospital Universitario Miguel Servet (HUMS) in Zaragoza, Spain. HUMS provides health care to a population size of about 400000 inhabitants, mostly urban, and more than 200 shoulder and upper extremity surgeries are performed every year.

Description

Inclusion Criteria:

  • Every patient who needs a peripheral nerve block performed by Anestesia Department.

Exclusion Criteria:

  • Patient refusal of peripheral nerve block.
  • Known allergy to amide local anaesthetic drugs
  • Absolute contraindications to perform a peripheral nerve block as coagulopathy, active infection at the block site or severe respiratory background.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peripheral nerve block Group
Every patient scheduled during 2011-2019 for the surgery needed a peripheral nerve block were enrolled.
Procedure: Peripheral nerve block
Peripheral nerve block consists of the administration of a local anaesthetic into the nerves to inhibit nerve transmission in a specific part of the body. Ultrasound or Nerve stimulator could be used to locate the peripheral nerve. A needle is placed through the anatomical references to administer local anaesthetic around the peripheral nerve. Single-shot or continuous blocks are performed preoperatively and postoperatively as current practice in the surgery theatre. Using ultrasound, in-plane or out-plane approach could be performed. Peripheral nerve block provides excellent intraoperative and postoperative analgesia decreasing the need for intravenous pain drugs. Interscalene block, supraclavicular block, safene block, femoral block, BRILMA block are different kinds of peripheral nerve block using in the anaesthestic current practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peripheral nerve block
Time Frame: During procedure
This primary outcome is the type of peripheral nerve block performed
During procedure
Incidence and frequency of Serious Adverse Events (SAE)
Time Frame: From performing the peripheral nerve block to 1-year follow-up
This primary outcome is the incidence, frequency and severity of Serious Adverse Events (SAE) as assessed by CTCAE v4.0 after peripheral nerve block.
From performing the peripheral nerve block to 1-year follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and frequency of Postoperative neurological complications (PONC)
Time Frame: From performing the peripheral nerve block to 1-year follow-up
This secondary outcome is the incidence, frequency and severity of Postoperative neurological complications (PONC) as assessed by CTCAE v4.0 after peripheral nerve block.
From performing the peripheral nerve block to 1-year follow-up
Local anesthetic used in peripheral nerve block
Time Frame: During procedure
Local anesthetic type (FDA drug) used in peripheral nerve block performance
During procedure
Local anesthetic dose used in peripheral nerve block
Time Frame: During procedure
Local anesthetic dose (mg) used in peripheral nerve block performance
During procedure
Local anesthetic volume used in peripheral nerve block
Time Frame: During procedure
Local anesthetic volume (ml) used in peripheral nerve block performance
During procedure
Nerve location technique used in peripheral nerve block
Time Frame: During procedure
Type of nerve location technique (ultrasound, nerve stimulator or paresthesia techinique) used in peripheral nerve block performance
During procedure
Peripheral nerve block operator
Time Frame: During procedure
Anesthesiologist operator of peripheral nerve block (attending or trainee).
During procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigación Sanitaria Aragón

Collaborators

Hospital Miguel Servet

Investigators

  • Principal Investigator: Pablo Oliver Forniés, MD, Hospital Miguel Servet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

November 30, 2019

Study Completion (Actual)

November 30, 2019

Study Registration Dates

First Submitted

June 25, 2020

First Submitted That Met QC Criteria

June 25, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POF-LEV-2019-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD will be available on file in storage and on the Internet (URL undecided yet) after finishing the data collection for 25 years at the participating site.

IPD Sharing Time Frame

Starting in July 2021 for 25 years. DOI: 10.1007/s00540-021-02989-7

IPD Sharing Access Criteria

  • To contact to Study Principal Investigator.
  • To provide to Study Principal Investigator a request to explain the reason to access to IPD study.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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