Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Device: tissue oxygenation saturation

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve block

Description

Inclusion Criteria:

• Informed consent
• American Society of Anesthesiologists physical statusⅠ-Ⅱ
• 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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
H group; Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.5% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests at 5 min were assessed before the block and at 5-min intervals till 30 min after the block.	Device: tissue oxygenation saturation; tissue oxygenation saturation
L group; Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.25% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests were assessed at 5 min before the block and at 5-min intervals till 30 min after the block.	Device: tissue oxygenation saturation; tissue oxygenation saturation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Regional tissue oxygenation saturation after successful femoral nerve block	rSO2	at 5-minute intervals till 30 minutes after regional block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Study Director: Xiangdong Chen, Doctor, Wuhan Union Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): May 10, 2019
• Study Completion (Actual): May 10, 2019

Study Registration Dates

• First Submitted: November 20, 2018
• First Submitted That Met QC Criteria: November 22, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): May 13, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral nerve block
• Other Study ID Numbers: XH20181118

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No