- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03538496
Comparison of Erector Spinae Plane Block With Thoracic Paravertebral Block for Video Assisted Thoracoscopic Surgery
May 9, 2019 updated by: Ali Ahiskalioglu, Ataturk University
Erector Spinae Plane Block Versus Thoracic Paravertebral Block on Postoperative Pain for Video Assisted Thoracoscopic Surgery
Erector Spinae Plane Block (ESPB) is a newly described and effective interfascial plane block for thoracic and abdominal surgery.
It was first described by Forero et al. in 2016, effectiveness being reported in four cases.
The paravertebral block has been successfully used in various surgical patient groups for purposes of anesthesia or postoperative pain management such as thoracotomy, breast surgery and abdominal surgery.
The aim of this study is to compare the analgesic effects of erector spinae plane block and paravertebral block in patients undergoing video assisted thoracoscopic surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
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
-
-
-
Erzurum, Turkey, 25100
- Ataturk University
-
-
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 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- American Society of Anesthesiologist's physiologic state I-III patients
- Undergoing video assisted thoracoscopic surgery
Exclusion Criteria:
- chronic pain
- bleeding disorders
- renal or hepatic insufficiency
- patients on chronic non-steroidal anti-inflammatory medications
- emergency cases
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ultrasound guided erector spinae plane block
ultrasound guided erector spinae plane block with 20 ml %0.25 bupivacaine
|
Single shot 20 ml 0.25 bupivacaine
|
Active Comparator: ultrasound guided paravertebral block
ultrasound guided paravertebral block with 20 ml %0.25 bupivacaine
|
Single shot 20 ml 0.25 bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative opioid consumption
Time Frame: First 24 hours
|
First 24 hours total fentanyl consumption with patient controlled analgesia
|
First 24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog pain score
Time Frame: postoperative 0-24 hours
|
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
|
postoperative 0-24 hours
|
Block performing time
Time Frame: First hour
|
The block time was defined as the period between the insertion of the needle and termination of local anesthetic administration
|
First hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
December 1, 2017
Primary Completion (Actual)
September 1, 2018
Study Completion (Actual)
September 30, 2018
Study Registration Dates
First Submitted
May 16, 2018
First Submitted That Met QC Criteria
May 16, 2018
First Posted (Actual)
May 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 10, 2019
Last Update Submitted That Met QC Criteria
May 9, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AUTF ANESTHESIA5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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