NIRS Measurement After SCP Block

Arterio-venous Fistula Clinical Trial

Official title:

Near-infrared Spectroscopy to Assess Changes in Tissue Oxygenation Following Supraclavicular Plexus Block in Patients Undergoing Vascular Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03044496
• Other study ID #: NIRS after SCP block
• Status: Completed
• First received: January 31, 2017
• Last updated: April 11, 2018
• Start date: September 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2018
• Source: Marienhospital Stuttgart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Peripheral regional anesthesia induces a sympathectomy-like effect with neurovascular changes causing increased arterial blood flow and venodilatation .

Near-infrared spectroscopy (NIRS) can be applied to different kinds of tissue providing oxygen saturation by detecting the absorption and reflection of near-infrared light .

The effect on peripheral tissue oxygenation in patients undergoing arteriovenous fistula revision has not yet been examined. We postulate an increase in tissue oxygenation by sympathicolysis caused by peripheral regional anesthesia that might be the reason for beneficial outcome. The aim of our study was to demonstrate the effect of a supraclavicular plexus block in this group of patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all patients undergoing surgery under regional anaesthesia

Exclusion Criteria:

• patients refusal

Related Conditions & MeSH terms

• Arterio-venous Fistula
• Arteriovenous Fistula
• Fistula

Intervention

Drug:
• Supraclavicular nerve block
Supraclavicular nerve block using ultrasound and 10ml ropivacaine 0.5% with 20ml mepivacaine 1%

Locations

Country	Name	City	State
Germany	Marienhospital Stuttgart, Dpt. of Anaesthesiology	Stuttgart	Baden Württemberg

Sponsors (1)

Lead Sponsor	Collaborator
Marienhospital Stuttgart

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NIRS after block	Absolute change from baseline value in tissue oxygenation	5 minutes before block until 30 minutes after block
Secondary	Difference between both arms	Absolute difference in tissue oxygenation between blocked arm and contralateral arm	5 minutes before block until 30 minutes after block