Infrared Thermography to Evaluate the Effect of Paravertebral Block

Completed

• Conditions: Paravertebral Block
• Interventions: Procedure: Paravertebral block at T4 and T5 level

• Registration Number: NCT04078347
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2019-10-01
• Primary Completion: 2020-08-30
• Study Completion: 2020-10-31
• Status Verified: 2020-11
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Successful Paravertebral block	Paravertebral block at T4 and T5 level	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.
Failed Paravertebral block	Paravertebral block at T4 and T5 level	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.

Primary Outcome Measures

Name	Time	Method
Changes of skin temperature	From baseline up to 20 minutes after block	Changes of skin temperature determined by infrared thermography

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China