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

Chronic Pain Clinical Trial

— RetroBlock  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066037
• Other study ID #: RetroBlock
• Status: Completed
• Phase: N/A
• First received: February 20, 2017
• Last updated: February 22, 2017
• Start date: January 1, 2009
• Est. completion date: November 13, 2016

Study information

• Verified date: February 2017
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: November 13, 2016
• Est. primary completion date: June 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy

• patients in legal custody

• age <18 years

Related Conditions & MeSH terms

• Chronic Pain
• Cluster Headache
• Headache
• Herpes Zoster
• Neuralgia
• Neuralgia, Postherpetic
• Neuropathic Pain
• Post Zoster Pain
• Post-Zoster Neuralgia
• Trigeminal Neuralgia

Intervention

Procedure:
• regional-anaesthesiological infiltration
Patients with therapy refractory chronic pain are treated with local infiltration techniques using e.g. local anaesthetics, opioids or drug combinations. Targeted structures are e.g. Ganglion stellatum, Ganglion pterygopallatinum, Trigeminal nerve branches (V1-V3). Patients receive a context- sensitive number of blocks in a series of infiltrations depenting on their pain course.

Locations

Country	Name	City	State
Germany	Charité hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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; International Association for the Study of Pain Neuropathic Pain Special Interest Group.. Interventional management of neuropathic pain: NeuPSIG recommendations. Pain. 2013 Nov;154(11):2249-61. doi: 10.1016/j.pain.2013.06.004. Review. — View Citation

Tafelski S, Beutlhauser T, Gouliou-Mayerhauser E, Fritzsche T, Denke C, Schäfer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS reduction during therapy	Reduction (relative and absolute) of pain during series of infiltrations comparing NRS scores before and after infiltrations	2 weeks
Secondary	Number of blocks in a series	Number of blocks in a series to achieve the targeted NRS reduction	4 weeks
Secondary	Time till recurrent pain	Time until a new series of blocks is requested by the patient	24 weeks
Secondary	clinical course of pain	NRS development during series of infiltrations	2 weeks
Secondary	type of infiltration	location of infiltrations with medication used	2 weeks
Secondary	co-parameters of pain chronification	co-factors of pain like co-morbidity, duration of pain disease, psychological diseases and association with primary outcome	2 weeks