Clinical trial NCT02846610: Registry for Acute Pain Treatment
Official title: Improvement of Acute Pain Treatment With Systemic and Regional Anesthesia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pain, Postoperative
Regional Anesthesia
Keywords: anesthesia
continuous regional anesthesia
complications
epidural analgesia
antibiotics
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
name: Ruhr University of Bochum
name: HELIOS Hospital, Bad Saarow, Germany
name: Technische Universität Dresden
name: HELIOS Hospital, Erfurt, Germany
name: Goethe University
name: BG Unfallklinik Frankfurt am Main
name: University of Hamburg-Eppendorf
name: Diakoniekrankenhaus Friederikenstift
name: Jena University Hospital
name: Hospital Ludwigsburg, Germany
name: Philipps University Marburg
name: Hospital Memmingen, Germany
name: St. Marien-Krankenhaus, Siegen, Germany
name: Städtisches Klinikum gGmbH, Solingen, Germany
name: University Hospital Freiburg
name: University Hospital Muenster
name: University Hospital of Cologne
name: HELIOS Klinikum Lengerich
name: Berlin DRK Hospital
name: Diakonie Hospital Bad Kreuznach
name: Ev. Hospital Unna
name: Josephs Hospital Warendorf
name: University Hospital Ulm
name: Johannes Gutenberg University Mainz
First posted: 2016-07-27
Enrollment: 224744
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Surgical and non-surgical patients with continuous regional anesthesia, single shot regional anesthesia, or intravenous patient-controlled analgesia

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)

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None.

Primary outcomes:
measure: Acute complications during insertion of regional anesthesia
timeFrame: at the day of insertion, day zero
Secondary outcomes:
measure: Pain levels after surgery
timeFrame: 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
measure: Satisfaction
timeFrame: after end of acute pain treatment, between day zero and up to day 90
measure: Complications of acute pain treatment
timeFrame: 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
Other outcomes:
Locations:
city: Homburg
country: Germany
facility: Saarland University Medical Center
state: Saarland
Study officials:
affiliation: University Hospital, Saarland
name: Thomas Volk, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.