Registry for Acute Pain Treatment

May 15, 2023 updated by: University Hospital, Saarland

Improvement of Acute Pain Treatment With Systemic and Regional Anesthesia

The German Network for acute pain management and Regional Anesthesia (NRA) is a multi-center, non-interventional registry and benchmark project, assessing and analysing clinical and patient-reported procedural and outcome data of systemic analgesia and regional anesthesia hosted by the German Society of Anesthesia and Intensive Care Medicine (DGAI) and professional Society German Anesthetists (BDA)

Study Overview

Status

Terminated

Conditions

Detailed Description

NRA offers the systematic documentation of patient related and procedure related components for acute pain treatments during and after surgery.

NRA collects preoperative, intraoperative, and postoperative data from treating physicians who complete a standard form. Data are collected concurrently with patient care by pain nurses or treating physicians and include detailed information about the medical conditions of patients having acute pain treatment along with the procedure and postoperative course.

The registry provides the basis for large scale analyses and benchmarks for several parameters.

The registry also aims at performing population-based research. Furthermore, its infrastructure allows for the conduct of prospective studies comparing the effectiveness of processes of care.

Study Type

Observational

Enrollment (Actual)

224744

Contacts and Locations

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

Study Contact

Study Locations

  • Germany
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Saarland University Medical Center

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

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Surgical and non-surgical patients with continuous regional anesthesia, single shot regional anesthesia, or intravenous patient-controlled analgesia

Description

Inclusion Criteria:

  • The investigators include anonymous data from patients with continuous regional anesthesia, single shot regional anesthesia, or systemic analgesia

Exclusion Criteria:

  • None.

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

Cohorts and Interventions

Group / Cohort
regional anesthesia
surgical patients (age: 0-100 years) having regional anesthesia along with the procedure and postoperative course
systemic analgesia
surgical patients (age: 0-100 years) having systemic analgesia along with the procedure and post procedure course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute complications during insertion of regional anesthesia
Time Frame: at the day of insertion, day zero
Procedural complications include dural puncture, bleeding, nerve damage, intoxication, malfunction, technical and equipment difficulties or failures.
at the day of insertion, day zero

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain levels after surgery
Time Frame: Daily visits (ward rounds) as long as in-hospital pain treatment is given; may take up to the length of the hospital stay, up to 90 days
Pain and pain related outcome measures (NRS at rest and on exertion, opioid and non-opioid consumption), interference of pain with activities, pain therapy side effects, pre-hospital existence of pain, information on general treatment
Daily visits (ward rounds) as long as in-hospital pain treatment is given; may take up to the length of the hospital stay, up to 90 days
Satisfaction
Time Frame: after end of acute pain treatment, between day zero and up to day 90
1. Patient and physician satisfaction: Satisfaction with the respective pain treatment reported by patients (verbal numeric rating scale ranging from 0 (=completely dissatisfied) to 10 (=completely satisfied).
after end of acute pain treatment, between day zero and up to day 90
Complications of acute pain treatment
Time Frame: Daily visits (ward rounds) as long as in-hospital pain treatment is given; may take up to the length of the hospital stay, between day zero and day 90
hypotension, sedation, urinary retention, infections, procedural complications such as nausea and vomiting, respiratory depression, itching, malfunction, nerve damage, intoxication, technical and equipment difficulties or failures
Daily visits (ward rounds) as long as in-hospital pain treatment is given; may take up to the length of the hospital stay, between day zero and day 90

Collaborators and Investigators

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

Sponsor

University Hospital, Saarland

Collaborators

Charite University, Berlin, Germany
Goethe University
University Hospital Muenster
Ruhr University of Bochum
Technische Universität Dresden
Johannes Gutenberg University Mainz
University Hospital Freiburg
University of Hamburg-Eppendorf
Philipps University Marburg Medical Center
University Hospital of Cologne
University Hospital Ulm
Jena University Hospital
Josephs Hospital Warendorf
Diakoniekrankenhaus Friederikenstift
HELIOS Hospital, Bad Saarow, Germany
HELIOS Hospital, Erfurt, Germany
Hospital Ludwigsburg, Germany
Hospital Memmingen, Germany
St. Marien-Krankenhaus, Siegen, Germany
Städtisches Klinikum gGmbH, Solingen, Germany
HELIOS Klinikum Lengerich
Berlin DRK Hospital
Diakonie Hospital Bad Kreuznach
Ev. Hospital Unna
BG Unfallklinik Frankfurt am Main

Investigators

  • Study Director: Thomas Volk, MD, University Hospital, Saarland

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

September 1, 2007

Primary Completion (Actual)

May 11, 2023

Study Completion (Actual)

May 11, 2023

Study Registration Dates

First Submitted

May 28, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 27, 2016

Study Record Updates

Last Update Posted (Actual)

May 17, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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