- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05083832
Effect of Two Different Plane Blocks on Post-thoracotomy Pain
Effects of Ultrasound-guided Continuous Erector Spina Plane Block and Continuous Serratus Anterior Plane Block on Post-thoracotomy Pain
Thoracotomy is recognized as one of the most painful surgical procedures. This increases the frequency of postoperative pulmonary complications. Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block (SAPB) are more superficial, easier to perform, and less likely to have complications. In addition, ESPB and SAPB applications are increasing in patients who underwent thoracotomy and thoracoscopic surgery.
In this study, the investigators aimed to evaluate the effect of continuous ESPB and continuous SAPB via US-guidance on post-thoracotomy pain.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Kecioren, Ankara, Turkey, 06000
- Ankara Atatürk Chest Disease and Chest Surgery Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 to 65 years old
- ASA physical status I-II-III
- BMI 18 to 30 kg/m2
- Elective thoracotomy surgery
Exclusion Criteria:
- Patient refusing the procedure
- Emergency surgery
- History of chronic opioid or analgesic used
Study Plan
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: Continuous erector spinae plane block
Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the erector spinae muscles until the interfascial space was reached.
After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area.
A catheter will be placed in this area.
Then, 5 ml/hour 0.125% bupivacaine will be infused via erector spinae plane block catheter.
|
Two different catheter techniques with same doses local anesthetic infusion
|
|
Active Comparator: Continuous serratus anterior plane block
Following the visualization of the anatomical structures, the nerve block needle was advanced via the in-plane technique beneath the serratus anterior muscles until the fourth rib area.
After hydrodissection with 2 ml normal saline, 20 ml 0.25% bupivacaine was injected into the area.
A catheter will be placed in this area.
Then, 5 ml/hour 0.125% bupivacaine will be infused via serratus anterior plane block catheter.
|
Two different catheter techniques with same doses local anesthetic infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain scores
Time Frame: 72 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, 48th and 72nd hours after surgery.
|
72 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine consumption
Time Frame: 24 hours after surgery
|
Morphine consumption for 24 hours will be recorded
|
24 hours after surgery
|
|
Side effects
Time Frame: 72 hours after surgery
|
Side effects, such as allergy to local anesthetics, hypotension, nausea/vomiting, itching, headache, and sweating will be recorded.
|
72 hours after surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E.Kurul-E1-21-1863
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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