Regional-anaesthesiological Infiltration Techniques for the Management of Chronic Pain: a Retrospective Study (RetroBlock)

February 22, 2017 updated by: Sascha Tafelski, Charite University, Berlin, Germany
There is a significant debate whether local infiltration techniques may be a method to treat complicated chronic pain syndromes, e.g. refractory headache. Until now there is a lack of evidence regarding efficacy of this treatment especially in long term follow up. Similarly, indication and management are under debate. Aim of this trial is to analyse pain scores during first treatment with anaesthesiological infiltration series.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 13353
        • Charite Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients are included with any refractory neuropathy, refractory headache or chronic disease with any invasive pain infiltration technique applied. All infiltration series are embedded in multi-modal therapy concepts.

Description

Inclusion Criteria:

  • patients with chronic pain disease undergoing regional-anaesthesiological infiltration series

Exclusion Criteria:

  • pregnancy
  • patients in legal custody
  • age <18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS reduction during therapy
Time Frame: 2 weeks
Reduction (relative and absolute) of pain during series of infiltrations comparing NRS scores before and after infiltrations
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of blocks in a series
Time Frame: 4 weeks
Number of blocks in a series to achieve the targeted NRS reduction
4 weeks
Time till recurrent pain
Time Frame: 24 weeks
Time until a new series of blocks is requested by the patient
24 weeks
clinical course of pain
Time Frame: 2 weeks
NRS development during series of infiltrations
2 weeks
type of infiltration
Time Frame: 2 weeks
location of infiltrations with medication used
2 weeks
co-parameters of pain chronification
Time Frame: 2 weeks
co-factors of pain like co-morbidity, duration of pain disease, psychological diseases and association with primary outcome
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Michael Schäfer, Prof., Charité University Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

November 13, 2016

Study Registration Dates

First Submitted

February 20, 2017

First Submitted That Met QC Criteria

February 22, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RetroBlock

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing can be requested and will be evaluated by Charité data safety authorities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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