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Pain, PostoperativeNCT02846610

Registry for Acute Pain Treatment

An observational study of Pain, Postoperative and Regional Anesthesia, run by University Hospital, Saarland at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 100 years
Conditions the study is for
Pain, Postoperative, Regional Anesthesia
How many people
224,744 participants
Where
1 siteGermany
Study dates
Sep 2007to 11 May 2023
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • None.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Saarland University Medical Center

    Homburg, Saarland, 66421

Other trials in Germany

About this study

Official title: 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)

Read the 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.

Keywords
anesthesia, continuous regional anesthesia, complications, epidural analgesia, antibiotics
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02846610
Study groupRoleWhat they receive
regional anesthesiasurgical patients (age: 0-100 years) having regional anesthesia along with the procedure and postoperative course
systemic analgesiasurgical patients (age: 0-100 years) having systemic analgesia along with the procedure and post procedure course

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute complications during insertion of regional anesthesia

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

    Measured: at the day of insertion, day zero

Secondary outcomes (3)

  1. 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

    Measured: 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

  2. 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).

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

  3. 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

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jul 2016 (estimated)
  2. Study startSep 2007
  3. Primary completion11 May 2023
  4. Study completion11 May 2023

Why it stopped: The registry has a new setpup and a new entry

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
224,744 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT02846610
Sponsor's protocol ID
NRA
Status last verified
May 2023
First submitted
28 May 2016
Last updated
17 May 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19918710

  • 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.

    PubMed 26994232

  • 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.

    PubMed 26040788

  • 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.

    PubMed 25474624

  • 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.

    PubMed 19890612

  • 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.

    PubMed 27355866

  • 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.

    PubMed 28806216

Questions about this trial

What is this clinical trial studying?

An observational study of Pain, Postoperative and Regional Anesthesia, run by University Hospital, Saarland at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The registry has a new setpup and a new entry). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute complications during insertion of regional anesthesia (time frame: at the day of insertion, day zero). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02846610, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.

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