- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05121727
Comparison of Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block
November 30, 2021 updated by: Musa Zengin, Atatürk Chest Diseases and Chest Surgery Training and Research Hospital
Comparison of the Effects of Ultrasound-Guided Erector Spinae Plane Block and Combination of Deep and Superficial Serratus Anterior Plane Block on Postoperative Acute Pain in Patients Undergoing Video-Assisted Thoracoscopic Surgery
Video-assisted thoracic surgery (VATS) has become a common procedure in thoracic surgery.
Severe postoperative pain may be encountered in patients undergoing VATS.
Analgesic methods such as thoracic paravertebral block (TPVB), intercostal block and erector spina plane block (ESPB) are widely used for VATS.
Among these methods, ultrasound (US) guided TPVB is the most preferred method.
In recent years, the frequency of application of plane blocks as a component of multimodal analgesia has been increased.
ESPB and SAPB are some of them.
Generally, comparisons are made between ESPB and TPVB in studies and the analgesic effect is evaluated.There are two techniques for SAPB application.
In Deep SAPB (DSAPB) application, local anesthetic agent is given under the serratus anterior muscle.
In the Superficial SAPB (SSAPB) application, the local anesthetic agent is given above the serratus anterior muscle.
Since it is done by entering from the same point in two applications, it is possible to perform these two applications at the same time with a single needle entry.
The mechanisms of regional analgesia techniques used after thoracic surgery operations are also different from each other.
Therefore, it may be possible to obtain a more effective analgesic effect in patients by combining the mechanism of action of DSAPB and SSAPB , as in the multimodal analgesia method.
This study seeks to evaluate the effect of ESPB and combined DSAPB-SSAPB pain after VATS.
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
-
-
Ankara
-
Kecioren, Ankara, Turkey, 06000
- Ankara Atatürk Chest Disease and Chest Surgery Training and Research 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
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age between 18 and 65 years
- American Society of Anesthesiologists physical status I-II-III
- Body mass index between 18-30 kg/m2
- Patients undergoing elective video assiste thoracoscopic surgery
Exclusion Criteria:
- Patient refusing the procedure
- History of chronic analgesic or opioid therapy
- History of local anesthetic allergy
- Infection in the intervention area
- Emergency surgery
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: Erector Spinae Plane Block
After the linear ultrasound (US) probe will be placed 2-3 cm lateral to the T5 spinous process, 20 ml of 0.25% bupivacaine hydrochloride will be injected into the interfacial space below the erector spinae muscle, above the transverse process.
|
Erector Spinae Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
20 ml of 0.25% bupivacaine will be used in applications.
|
Active Comparator: Deep and Superficial Serratus Anterior Plane Block
In patients who are planned to have combined deep and superficial serratus anterior plane block, following the visualization of the anatomical structures, the nerve block needle will be advanced via the in-plane technique beneath the serratus anterior muscles until the interfascial space was reached.
After hydrodissection with 2 ml normal saline, 10 ml 0.25% bupivacaine will be injected into the area.
Then, with the same needle, will be returned 1-2 cm from the deep serratus anteror area to superficial serratus anteror area above the serratus anterior muscle and will be injected 2 ml normal saline for hydrodissection.
Finally 10 ml of 0.25% bupivacaine will be injected for superficial serratus anetrior block into the interfacial area.
|
Combined Deep and Superficial Serratus Anterior Plane Block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
20 ml of 0.25% bupivacaine will be used in applications.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores
Time Frame: 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery
|
Pain will be assessed at rest and while coughing using the visual analog scale on a scale from 0 (no pain) to 10 (worst pain).
Pain assessment will be done at 1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery.
|
1st, 2nd, 4th, 8th, 16th, 24th and 48th hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine Consumption
Time Frame: 24 hours after surgery
|
Postoperative intravenous morphine infusion therapy will be administered with patient-controlled analgesia (PCA) method.
Thanks to PCA, how much morphine the patient needs will be followed in mg.
|
24 hours after surgery
|
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)
June 6, 2021
Primary Completion (Actual)
November 22, 2021
Study Completion (Actual)
December 1, 2021
Study Registration Dates
First Submitted
October 23, 2021
First Submitted That Met QC Criteria
November 3, 2021
First Posted (Actual)
November 16, 2021
Study Record Updates
Last Update Posted (Actual)
December 2, 2021
Last Update Submitted That Met QC Criteria
November 30, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.Kurul-E1-21-1862
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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