NCT04078347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 6, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2020

Completed
Last Updated

January 12, 2021

Status Verified

November 1, 2020

Enrollment Period

11 months

First QC Date

August 6, 2019

Last Update Submit

January 8, 2021

Conditions

Paravertebral Block

Keywords

Paravertebral blockInfrared thermography

Outcome Measures

Primary Outcomes (1)

  • Changes of skin temperature

    Changes of skin temperature determined by infrared thermography

    From baseline up to 20 minutes after block

Secondary Outcomes (4)

  • Noinvasive blood pressure

    From baseline up to 20 minutes after block

  • Heart rate

    From baseline up to 20 minutes after block

  • SPO2

    From baseline up to 20 minutes after block

  • Sensory block level

    From baseline up to 20 minutes after block

Study Arms (2)

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

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

Interventions

Paravertebral block at T4 and T5 levelPROCEDURE

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 blockSuccessful Paravertebral block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • With informed consent
  • American Society of Anesthesiologists physical status Ⅰ-Ⅱ
  • Undergo elective surgery with planned paravertebral block

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

  • 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.

    PMID: 34116642DERIVED

Study Officials

  • Wei Mei

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College

Study Record Dates

First Submitted

August 6, 2019

First Posted

September 6, 2019

Study Start

October 1, 2019

Primary Completion

August 30, 2020

Study Completion

October 31, 2020

Last Updated

January 12, 2021

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

For patient's privacy

Locations

CN(1)