Registry for Acute Pain Treatment

NCT02846610 | Terminated

• 1 other identifier: NRA
• Study Type: observational
• Target: 224,744
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Pain, Postoperative; Regional Anesthesia

Keywords

anesthesia; continuous regional anesthesia; complications; epidural analgesia; antibiotics

Outcome Measures

Primary Outcomes (1)

• Acute complications during insertion of regional anesthesia

  Procedural complications include dural puncture, bleeding, nerve damage, intoxication, malfunction, technical and equipment difficulties or failures.

  at the day of insertion, day zero

Secondary Outcomes (3)

• Pain levels after surgery

  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

  after end of acute pain treatment, between day zero and up to day 90

• Complications of acute pain treatment

  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

Study Arms (2)

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

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None.

Sponsors & Collaborators

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

Study Sites (1)

Saarland University Medical Center

Homburg, Saarland, 66421, Germany

Location

Related Publications (7)

• Volk T, Engelhardt L, Spies C, Steinfeldt T, Kutter B, Heller A, Werner C, Heid F, Burkle H, Koch T, Vicent O, Geiger P, Kessler P, Wulf H. [A German network for regional anaesthesia of the scientific working group regional anaesthesia within DGAI and BDA]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2009 Nov;44(11-12):778-80. doi: 10.1055/s-0029-1242127. Epub 2009 Nov 16. German.

  PMID: 19918710 BACKGROUND

• Bomberg H, Kubulus C, Herberger S, Wagenpfeil S, Kessler P, Steinfeldt T, Standl T, Gottschalk A, Stork J, Meissner W, Birnbaum J, Koch T, Sessler DI, Volk T, Raddatz A. Tunnelling of thoracic epidural catheters is associated with fewer catheter-related infections: a retrospective registry analysis. Br J Anaesth. 2016 Apr;116(4):546-53. doi: 10.1093/bja/aew026.

  PMID: 26994232 BACKGROUND

• Bomberg H, Albert N, Schmitt K, Graber S, Kessler P, Steinfeldt T, Hering W, Gottschalk A, Standl T, Stork J, Meissner W, Tessmann R, Geiger P, Koch T, Spies CD, Volk T, Kubulus C. Obesity in regional anesthesia--a risk factor for peripheral catheter-related infections. Acta Anaesthesiol Scand. 2015 Sep;59(8):1038-48. doi: 10.1111/aas.12548. Epub 2015 Jun 4.

  PMID: 26040788 BACKGROUND

• Bomberg H, Kubulus C, List F, Albert N, Schmitt K, Graber S, Kessler P, Steinfeldt T, Standl T, Gottschalk A, Wirtz SP, Burgard G, Geiger P, Spies CD, Volk T; German Network for Regional Anaesthesia Investigators. Diabetes: a risk factor for catheter-associated infections. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):16-21. doi: 10.1097/AAP.0000000000000196.

  PMID: 25474624 BACKGROUND

• Volk T, Engelhardt L, Spies C, Steinfeldt T, Gruenewald D, Kutter B, Heller A, Werner C, Heid F, Burkle H, Gastmeier P, Wernecke KD, Koch T, Vicent O, Geiger P, Wulf H. [Incidence of infection from catheter procedures for regional anesthesia: first results from the network of DGAI and BDA]. Anaesthesist. 2009 Nov;58(11):1107-12. doi: 10.1007/s00101-009-1636-7. German.

  PMID: 19890612 BACKGROUND

• Kubulus C, Schmitt K, Albert N, Raddatz A, Graber S, Kessler P, Steinfeldt T, Standl T, Gottschalk A, Meissner W, Wirtz SP, Birnbaum J, Stork J, Volk T, Bomberg H. Awake, sedated or anaesthetised for regional anaesthesia block placements?: A retrospective registry analysis of acute complications and patient satisfaction in adults. Eur J Anaesthesiol. 2016 Oct;33(10):715-24. doi: 10.1097/EJA.0000000000000495.

  PMID: 27355866 BACKGROUND

• Bomberg H, Huth A, Wagenpfeil S, Kessler P, Wulf H, Standl T, Gottschalk A, Doffert J, Hering W, Birnbaum J, Spies C, Kutter B, Winckelmann J, Burgard G, Vicent O, Koch T, Sessler DI, Volk T, Raddatz A. Psoas Versus Femoral Blocks: A Registry Analysis of Risks and Benefits. Reg Anesth Pain Med. 2017 Nov/Dec;42(6):719-724. doi: 10.1097/AAP.0000000000000643.

  PMID: 28806216 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Thomas Volk, MD

  University Hospital, Saarland

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2016
• First Posted: July 27, 2016
• Study Start: September 1, 2007
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)