Infrared Thermography to Evaluate the Effect of Paravertebral Block

Paravertebral Block Clinical Trial

Official title:

Changes of Skin Temperature for Evaluation of Paravertebral Block: A Prospective Observational Study Using Infrared Thermography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04078347
• Other study ID #: TJ-IRB20190424
• Status: Completed
• Start date: October 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: November 2020
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this prospective observational study was to evaluate the changes of skin temperature after the paravertebral block measured by infrared thermography.

Description:

Methods: Patients scheduled for elective surgery with paravertebral block will receive infrared thermography measures 5 min before the block and continous to 20 min after the block. The sensitivity, specificity of infrared thermography as diagnostic methods will be determined by receiver operator characteristic analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: October 31, 2020
• Est. primary completion date: August 30, 2020
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• With informed consent

• American Society of Anesthesiologists physical status ?-?

• Undergo elective surgery with planned paravertebral block

Exclusion Criteria:

• Refusal to participate in the study

• pre-existing infection at the block site

• younger than 18-yr-old

• BMI>35

• significant thoracic kyphoscoliosis

• Those who had taken vasodilatory drugs before surgery

• history of previous thoracic or breast surgery

• Preoperative analgesic medications

• Any contraindications to peripheral nerve block such as coagulation abnormalities, allergy to local anaesthetics, peripheral neuropathy.

Related Conditions & MeSH terms

• Paravertebral Block

Intervention

Procedure:
• Paravertebral block at T4 and T5 level
Paravertebral block is performed at T4 and T5 level under realtime ultrasound guidenance with 10ml of 0.5% ropivacaine for each block, respectively.

Locations

Country	Name	City	State
China	Tongji 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	Changes of skin temperature	Changes of skin temperature determined by infrared thermography	From baseline up to 20 minutes after block
Secondary	Noinvasive blood pressure	Vital signs	From baseline up to 20 minutes after block
Secondary	Heart rate	Vital signs	From baseline up to 20 minutes after block
Secondary	SPO2	vital signs	From baseline up to 20 minutes after block
Secondary	Sensory block level	Sensory block level determined by pinprick.	From baseline up to 20 minutes after block