Infrared Thermography to Evaluate the Effect of Paravertebral Block

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

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

Study Overview

• Status: Completed
• Conditions: Paravertebral Block
• Intervention / Treatment: Procedure: Paravertebral block at T4 and T5 level

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients scheduled for elective surgery with planned paravertebral block for multimodel analgesia.

Description

Inclusion Criteria:

• With informed consent
• American Society of Anesthesiologists physical status Ⅰ-Ⅱ
• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Successful Paravertebral block; Pinprick test was evaluated at 20 min after Paravertebral block. Pinprick sensation was assessed using a 22-gauge short bevel needle from T2 to T10 at midclavicular line bilaterally . Pinprick response was recorded quantitatively as 1 (sensation) or 0 (no sensation/numb). Successful block was defined as the pinprick score was 0 at 20 min after block. Otherwise, it was defined as a failed block.	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.
Failed Paravertebral block; Pinprick test was evaluated at 20 min after Paravertebral block. Pinprick sensation was assessed using a 22-gauge short bevel needle from T2 to T10 at midclavicular line bilaterally . Pinprick response was recorded quantitatively as 1 (sensation) or 0 (no sensation/numb). Successful block was defined as the pinprick score was 0 at 20 min after block. Otherwise, it was defined as a failed block.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of skin temperature	Changes of skin temperature determined by infrared thermography	From baseline up to 20 minutes after block

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Noinvasive blood pressure	Vital signs	From baseline up to 20 minutes after block
Heart rate	Vital signs	From baseline up to 20 minutes after block
SPO2	vital signs	From baseline up to 20 minutes after block
Sensory block level	Sensory block level determined by pinprick.	From baseline up to 20 minutes after block

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: Wei Mei, Huazhong University of Science and Technology

Publications and helpful links

General Publications

• Zhang S, Liu Y, Liu X, Liu T, Li P, Mei W. Infrared thermography for assessment of thoracic paravertebral block: a prospective observational study. BMC Anesthesiol. 2021 Jun 11;21(1):168. doi: 10.1186/s12871-021-01389-4.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): August 30, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: September 3, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Paravertebral block; Infrared thermography
• Other Study ID Numbers: TJ-IRB20190424

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: For patient's privacy

Drug and device information, study documents

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