- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03066037
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
-
-
-
Berlin, Germany, 13353
- Charité 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.
Investigators
- Principal Investigator: Michael Schäfer, Prof., Charite 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
- Dworkin RH, O'Connor AB, Kent J, Mackey SC, Raja SN, Stacey BR, Levy RM, Backonja M, Baron R, Harke H, Loeser JD, Treede RD, Turk DC, Wells CD. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-2261. doi: 10.1016/j.pain.2013.06.004. Epub 2013 Jun 6.
- Tafelski S, Beutlhauser T, Gouliou-Mayerhauser E, Fritzsche T, Denke C, Schafer M. [Practice of regional anesthesia for chronic pain patients in specialized pain services : A nationwide survey in Germany]. Schmerz. 2015 Apr;29(2):186-94. doi: 10.1007/s00482-014-1503-6. German.
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
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Virus Diseases
- Infections
- Pain
- Neurologic Manifestations
- Neuromuscular Diseases
- Stomatognathic Diseases
- Mouth Diseases
- Peripheral Nervous System Diseases
- DNA Virus Infections
- Cranial Nerve Diseases
- Herpesviridae Infections
- Headache Disorders, Primary
- Headache Disorders
- Varicella Zoster Virus Infection
- Facial Nerve Diseases
- Trigeminal Autonomic Cephalalgias
- Trigeminal Nerve Diseases
- Facial Neuralgia
- Chronic Pain
- Neuralgia
- Headache
- Herpes Zoster
- Cluster Headache
- Trigeminal Neuralgia
- Neuralgia, Postherpetic
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.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Washington University School of MedicineCompletedHip Pain Chronic | Back Pain | Chronic Pain | Knee Pain ChronicUnited States
Clinical Trials on regional-anaesthesiological infiltration
-
Charite University, Berlin, GermanyCompletedPostoperative Complications | Postoperative Pain | Knee ArthropathyGermany
-
Ospedale di Circolo - Fondazione MacchiCompleted
-
King Edward Medical UniversityCompleted
-
Tribhuvan University Teaching Hospital, Institute...Recruiting
-
Sun Yat-sen UniversityUnknownType 2 Diabetes | Flash Glucose Monitoring | ConscienceChina
-
Capital Medical UniversityUnknownStroke | Hypothermia | NeuroprotectionChina
-
Charite University, Berlin, GermanyRecruiting
-
Vinmec Healthcare SystemTerminated
-
Centre Hospitalier Departemental VendeeCompleted