Infrared Thermography to Evaluate the Effect of Paravertebral Block

Sponsor

Huazhong University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT04078347

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Paravertebral Block	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 Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 1, 2019

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Oct 31, 2020

Arms and Interventions

Arm	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.

Arm

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

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.

Outcome Measures

Primary Outcome Measures

Changes of skin temperature [From baseline up to 20 minutes after block]
Changes of skin temperature determined by infrared thermography

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tongji Hospital	Wuhan	Hubei	China	430030

Sponsors and Collaborators

Huazhong University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wei Mei, Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

ClinicalTrials.gov Identifier:

NCT04078347

Other Study ID Numbers:

TJ-IRB20190424

First Posted:

Sep 6, 2019

Last Update Posted:

Jan 12, 2021

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wei Mei, Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Paravertebral block

Infrared thermography

Study Results

No Results Posted as of Jan 12, 2021