- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04829409
The Effects of Three Different Ultrasound-guided Nerve Blocks in VATS
April 13, 2022 updated by: Wenlong Yao, Huazhong University of Science and Technology
The Effects of Ultrasound-guided Mid-point Transverse Process to Pleura Block, Erector Spinae Plane Block and Paravertebral Block on Postoperative Pain in Video-assisted Thoracic Surgery
Ultrasound-guided mid-point transverse process to pleura block, erector spinae plane block and paravertebral block are three different methods of nerve block, used for relieving postoperative pain in thoracic anesthesia.
This study is to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Ultrasound-guided nerve block is an important part of multi-mode analgesia to decrease the consumption of opioids.
Thoracic paravertebral block is considered as an ideal regional analgesic choice for video-assisted thoracic surgery, but it still has some side effects, such as pneumothorax, vascular injury, especially for novices.
Recent years, ultrasound-guided mid-point transverse process to pleura block and erector spinae plane block are reported for thoracic surgery.
The insertion depth in these two methods is more superficial than traditional paravertebral block.
They could have less side effects.
Therefore, we design a randomised control study to compare them on block effects, postoperative pain and analgesic consumption in video-assisted thoracic surgery.
Study Type
Interventional
Enrollment (Anticipated)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wenlong Yao, MD
- Phone Number: 86-27-83663173
- Email: wlyao82@126.com
Study Locations
-
-
Hubei
-
Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital, Huazhong University of Science and Technology
-
Contact:
- Ailin Luo, Ph.D.,M.D.
- Phone Number: +86-27-83663282
- Email: alluo@tjh.tjmu.edu.cn
-
Principal Investigator:
- Wenlong Yao, Ph.D.,M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- selective lobetomy under VATS
- ASA classfication 1-3
Exclusion Criteria:
- history of thoracic surgery
- double lateral VATS
- allergy to local anesthetics
- coagulation disorders
- severe heart diseases, hepatic or renal insufficiency
- a history of chronic pain or chronic opioid use
- psychiatric disease or uncooperative
- BMI>28 kg/m2
- VATS transfered to open thoractomy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: paravertebral block
Patients receive ultrasound-guided paravertebral block
|
Patients receive ultrasound-guided paravertebral block
|
|
Active Comparator: ESP block
Patients receive ultrasound-guided erector spinae plane (ESP) block
|
Patients receive ultrasound-guided erector spinae plane (ESP) block
|
|
Experimental: MTP block
Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block
|
Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative morphine consumption
Time Frame: postoperative 24 hours
|
The dose is according to the record from PCA pump
|
postoperative 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score at rest
Time Frame: at 0, 8, 24 hour after surgery
|
measured by VAS (0-10)
|
at 0, 8, 24 hour after surgery
|
|
Pain score while coughing
Time Frame: at 0, 8, 24 hour after surgery
|
measured by VAS (0-10)
|
at 0, 8, 24 hour after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
block level
Time Frame: 20 minutes after block
|
measured by pin-prick at clavicle midline
|
20 minutes after block
|
|
intraoperative analgesic comsumption
Time Frame: intraoperative, from induction to emergence from anesthesia
|
the dose of sufentanil, remifentanil
|
intraoperative, from induction to emergence from anesthesia
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ailin Luo, MD,PhD, Tongji Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 5, 2021
Primary Completion (Anticipated)
October 1, 2022
Study Completion (Anticipated)
December 1, 2022
Study Registration Dates
First Submitted
March 30, 2021
First Submitted That Met QC Criteria
April 1, 2021
First Posted (Actual)
April 2, 2021
Study Record Updates
Last Update Posted (Actual)
April 14, 2022
Last Update Submitted That Met QC Criteria
April 13, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJMZK20210301
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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