- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05242328
Postoperative Analgesia y After Uniportal Video-assisted Thoracoscopic Surgery
February 23, 2023 updated by: National Cheng-Kung University Hospital
Comparison of Surgical Thoracoscopic Intercostal Nerve Block and Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia and Enhanced Recovery After Uniportal Video-assisted Thoracoscopic Surgery: a Double-blinded, Randomized Controlled Trial
Ultrasound-guided erector spinae plane block (ESPB) is an interfascial blockade during thoracic anesthesia, first described by Forero in 2016, and is highlighted by technically feasibility and less complication rate.
The patient is placed as decubitus position.
The anesthesiologists use echo to identify the ipsilateral transverse process at T5 level, and insert the needle to 2-3 cm lateral to the spinous process until contact the transverse process.
Then the injected local anesthetic will penetrate via erector spinae muscle to paravertebral space to affect and relieve pain.
Study Overview
Status
Recruiting
Study Type
Interventional
Enrollment (Anticipated)
40
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 Locations
-
-
-
Tainan, Taiwan
- Recruiting
- National Cheng Kung University Hospital
-
-
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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, over 20 years old, u
- undergoing elective uniportal VATS lobectomy.
Exclusion Criteria:
- patient refusal,
- body mass index > 35 kg/m2,
- American society of anesthesiologists (ASA) grade above 3,
- contraindication to nerve block,
- allergy to analgesic agents,
- regular opioid used for chronic pain prior to this time surgery,
- conversion to thoracotomy or VATS procedure,
- postoperative intubation,
- postoperative intensive care unit admission.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: post-operative VAS score of Ultrasound-guided erector spinae plane block
|
Ultrasound-guided erector spinae plane block
|
Active Comparator: post-operative VAS score of surgical thoracoscopic intercostal nerve block
|
surgical thoracoscopic intercostal nerve block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analogue scale
Time Frame: post-op 2 days
|
post-op VAS score, 0-10, the higher means painful, and "0" point no pain.
|
post-op 2 days
|
accumulated morphine usage dose
Time Frame: post-op 2 days
|
accumulated morphine usage dose
|
post-op 2 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
January 5, 2021
Primary Completion (Anticipated)
December 26, 2024
Study Completion (Anticipated)
December 26, 2024
Study Registration Dates
First Submitted
January 26, 2022
First Submitted That Met QC Criteria
February 15, 2022
First Posted (Actual)
February 16, 2022
Study Record Updates
Last Update Posted (Estimate)
February 27, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
December 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- A-ER-110-293
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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