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NCT03753594 Clinical Trial

Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block

Anesthesia, Local Clinical Trial

Official title:
Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block With Ropivacaine at Different Concentrations

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03753594
Other study ID # XH20181118
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 30, 2018
Est. completion date May 10, 2019

Study information
Verified date May 2019
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and determine whether the changes of regional tissue oxygenation saturation can be affected by the concentration of ropivacaine.

Description:

Successful peripheral nerve blocks induce sympathetic blockade, which increases local blood flow by vasodilation. The relationship between successful femoral nerve block and the variation of regional tissue oxygenation saturation was unclear.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 10, 2019
Est. primary completion date May 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- Informed consent

- American Society of Anesthesiologists physical status?-?

- Undergo elective elective knee arthroscopy with peripheral nerve block

Exclusion Criteria:

- Refusal to participate in the study

- BMI>35

- Any contraindications to peripheral nerve block such as coagulation abnormalities, •Allergy to local anaesthetics, peripheral neuropathy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• tissue oxygenation saturation
tissue oxygenation saturation

Locations
Country Name City State
China Union Hospital Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Regional tissue oxygenation saturation after successful femoral nerve block rSO2 at 5-minute intervals till 30 minutes after regional block
Secondary Pinprick sensory scores A 3-level scale was used to grade the intensity of sensory block using pinprick stimulation: 0=normal sensation; 1=analgesia; 2=anesthesia. 5 minute before regional block and at 5-minute intervals till 30 minutes after regional block
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