InfectionNCT00251654
Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia
An observational study of Infection and Inflammation, run by Rechbergklinik Bretten at 1 site in Germany.
Trial summary
The investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Infection, Inflammation, Adverse Effects
- What is being tested?
- perineural block (anesthesia)
- Type of treatment
- Surgery or procedure
- How many people
- 9,000 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2002to Dec 2008
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving perineural blocks via catheter ASA 1 to 4
Who may be able to join
- All patients receiving perineural blocks via catheter
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia Results of Investigations on 3,491 Catheters
The investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording.
Read the detailed description
Perineural blocks with catheter placement are more and more frequently used. Few data dealing with infectious complications of perineural catheters exist. We assess incidence and localization of infectious complications of perineural catheters by means of computerized data acquisition. We prospectively evaluate perineural catheters placed at different sites for regional anesthesia and postoperative analgesia. The catheters were placed under standardized sterile conditions by using the nerve stimulator technique. Local inflammation is defined as the presence of at least two of the three signs: redness, pain on pressure or swelling. Infection is defined as the presence of at least two of the following criteria: pus at the catheter insertion site, fever, increased CRP and/or leukocytes requiring antibiotic therapy.
- Conditions
- Infection, Inflammation, Adverse Effects
- Being tested
- perineural block (anesthesia)
- Keywords
- complications, adverse events, regional anesthesia, adverse effects
- Medical subject headings
- Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineural block (anesthesia)Procedure or surgery
continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2005 (estimated)
- Study startJan 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 9,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rechbergklinik Bretten
- Sponsor type
- University, hospital or other
- Collaborators
- BG Unfallklinik Murnau
- Investigators
- Johannes Büttner, MD, Study chair, BG Unfallklinik Murnau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00251654
- Sponsor's protocol ID
- MRA001
- Status last verified
- Sep 2009
- First submitted
- 9 Nov 2005
- Last updated
- 1 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Neuburger M, Breitbarth J, Reisig F, Lang D, Buttner J. [Complications and adverse events in continuous peripheral regional anesthesia Results of investigations on 3,491 catheters]. Anaesthesist. 2006 Jan;55(1):33-40. doi: 10.1007/s00101-005-0920-4. German.
PubMed 16193317Neuburger M, Buttner J, Blumenthal S, Breitbarth J, Borgeat A. Inflammation and infection complications of 2285 perineural catheters: a prospective study. Acta Anaesthesiol Scand. 2007 Jan;51(1):108-14. doi: 10.1111/j.1399-6576.2006.01173.x. Epub 2006 Nov 1.
PubMed 17073856Neuburger M, Reisig F, Zimmermann L, Buttner J. [Infection control in continuous peripheral regional anesthesia. Clinical study on disinfection time and subcutaneous tunneling in interscalene plexus anesthesia]. Anaesthesist. 2009 Aug;58(8):795-9. doi: 10.1007/s00101-009-1586-0. German.
PubMed 19669706
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complications and Adverse Effects in Continuous Peripheral Regional Anesthesia Results of Investigations on 3,491 Catheters
- ClinicalTrials.gov ID
- NCT00251654
- Acronym / sponsor ID
- MRA001
- Conditions
- Infection, Inflammation, Adverse Effects
- Keywords
- complications, adverse events, regional anesthesia, adverse effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,000 participants (actual)
- Lead sponsor
- Rechbergklinik BrettenUniversity, hospital or other
- Collaborators
- BG Unfallklinik Murnau
- Study start
- Jan 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 10 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording.
Detailed description
Perineural blocks with catheter placement are more and more frequently used. Few data dealing with infectious complications of perineural catheters exist. We assess incidence and localization of infectious complications of perineural catheters by means of computerized data acquisition. We prospectively evaluate perineural catheters placed at different sites for regional anesthesia and postoperative analgesia. The catheters were placed under standardized sterile conditions by using the nerve stimulator technique. Local inflammation is defined as the presence of at least two of the three signs: redness, pain on pressure or swelling. Infection is defined as the presence of at least two of the following criteria: pus at the catheter insertion site, fever, increased CRP and/or leukocytes requiring antibiotic therapy.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving perineural blocks via catheter ASA 1 to 4
Key inclusion criteria (1 listed)
- All patients receiving perineural blocks via catheter
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perineural block (anesthesia)continuous peripheral regional anesthesia ropivacaine 0.33% for 3 to 5 days | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2009.
- Results publication: PubMed 16193317Neuburger M, Breitbarth J, Reisig F, Lang D, Buttner J. [Complications and adverse events in continuous peripheral regional anesthesia Results of investigations on 3,491 catheters]. Anaesthesist. 2006 Jan;55(1):33-40. doi: 10.1007/s00101-005-0920-4. German.
- Results publication: PubMed 17073856Neuburger M, Buttner J, Blumenthal S, Breitbarth J, Borgeat A. Inflammation and infection complications of 2285 perineural catheters: a prospective study. Acta Anaesthesiol Scand. 2007 Jan;51(1):108-14. doi: 10.1111/j.1399-6576.2006.01173.x. Epub 2006 Nov 1.
- Results publication: PubMed 19669706Neuburger M, Reisig F, Zimmermann L, Buttner J. [Infection control in continuous peripheral regional anesthesia. Clinical study on disinfection time and subcutaneous tunneling in interscalene plexus anesthesia]. Anaesthesist. 2009 Aug;58(8):795-9. doi: 10.1007/s00101-009-1586-0. German.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johannes Büttner, MD study chair
BG Unfallklinik Murnau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Inflammation, run by Rechbergklinik Bretten 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: finished, as of the sponsor's last update on 1 Oct 2009. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00251654, which also lists 3 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 1 Oct 2009; AzTrials last refreshed its copy on 4 Nov 2026.