- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06177652
Postoperative Analgesis for Pain Management After Thoracotomy
March 5, 2025 updated by: Nur Nazire Yucal, Kocaeli University
Comparison of Thoracal Paravertebral Block and Serratus Plan Block in Pain Management After Thoracotomy
Thoracotomy is among the most painful surgical procedures and can cause severe pain.
Postoperative pain causes many complications.
Therefore, pain management is important in patients undergoing thoracotomy.
For this purpose, systemic analgesics are used along with ultrasound-guided nerve blocks in thoracotomy pain.
The effectiveness of thoracic paravertebral block and serratus plane block in the treatment of post-thoracotomy pain will be evaluated by comparing their effectiveness and complications on postoperative pain.
Since the epidural spread of the thoracic paravertebral block is more effective, the effectiveness of postoperative pain relief will be more effective
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Thoracotomy is among the most painful surgical procedures and can cause severe pain.
This pain causes postoperative complications in patients who have thoracotomy surgery.
Uncontrolled pain can cause respiratory and thromboembolic events.
Therefore, effective pain management is important in patients undergoing thoracotomy.
Investigators aim to compare the analgesic effectiveness and complications of thoracic paravertebral block and serratus anterior plane block in relieving thoracotomy pain, which is one of the most painful surgical procedures.
It is aimed to compare the effectiveness and complications of thoracic paravertebral block and serratus plane block in postoperative pain control after thoracotomy.
Providing pain control reduces postoperative complications and reduces hospital stay, which increases patient comfort and reduces costs.
In this research, postoperative morphine consumption after block applications will be compared, and patients' analgesic needs will be evaluated according to the participants' VAS score.
Post-operative 3rd, 6th, 9th, 12th, 24th.
Morphine consumption will be evaluated by monitoring the hours.
It will be evaluated whether there is a need for additional analgesics.
During the operation, the patient's heart rate, blood pressure, saturation and temperature variable values will be closely monitored.
Standard monitoring methods will be used when examining these parameters.
Study Type
Interventional
Enrollment (Actual)
58
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
-
-
-
Kocaeli, Turkey
- Kocaeli University
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Kocaeli, Turkey
- Nur Nazire Yucal
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 18-75 aged patients
- American Society of Anesthesiologists Classification (ASA) I-II-III patients
- patients who scheduled elective thoracic surgery
Exclusion Criteria:
- American Society of Anesthesiologists Classification (ASA) IV-V patients
- patients with coagulopathy
- patient with infection at the injection site
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: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Paravertebral Block
Ultrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group.
|
Ultrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group.
|
|
Active Comparator: Serratus Plane Block
Ultrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group.
|
Ultrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphin consumption
Time Frame: during postoperative 24 hour
|
Patient in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia
|
during postoperative 24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: during postoperative 24 hour
|
Visual Analogue Scale (VAS) requires the patient to rate their pain on a defined scale.For example , 0-10 where 0 is no pain and 10 is the worst pain imaginable
|
during postoperative 24 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Tülay Çardaközü, Kocaeli University
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 1, 2022
Primary Completion (Actual)
July 4, 2024
Study Completion (Actual)
July 4, 2024
Study Registration Dates
First Submitted
December 11, 2023
First Submitted That Met QC Criteria
December 11, 2023
First Posted (Actual)
December 20, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 5, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KAEK/10.bI.02
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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