Registry for Acute Pain Treatment

Pain, Postoperative Clinical Trial

Official title:

Improvement of Acute Pain Treatment With Systemic and Regional Anesthesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02846610
• Other study ID #: NRA
• Status: Terminated
• Start date: September 2007
• Est. completion date: May 11, 2023

Study information

• Verified date: May 2023
• Source: Universität des Saarlandes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 224744
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Acute Pain
• Pain, Postoperative
• Regional Anesthesia

Locations

Country	Name	City	State
Germany	Saarland University Medical Center	Homburg	Saarland

Sponsors (26)

Lead Sponsor

Collaborator

University Hospital, Saarland

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

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain levels after surgery	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
Secondary	Satisfaction	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
Secondary	Complications of acute pain treatment	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