- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06996691
- Original Trial
Erector Spinae Plane Block Versus Serratus Anterior Plane Block in VATS (VATS)
A Comparative Study of Erector Spinae Plane Block Versus Serratus Anterior Plane Block for Postoperative Analgesia After Video-assisted Thoracoscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Minimally invasive thoracic surgery (MITS) has become more common over the past decade, with the proportion of lung resections performed using this technique increasing from 16% in 2005 to 47% in 2015.
VATS is a minimally invasive procedure that allows rapid recovery compared to thoracic surgery. Patients scheduled for VATS experience moderate to severe pain following the procedure. This represents a significant burden peri-operatively as there is a strong relationship between poor pain control and the development of complications like pneumonia and atelectasis due to interference with spontaneous deep breathing & coughing. These complications have a negative impact on functional recovery; therefore, adequate postoperative pain relief assists in improving functional outcomes & accelerates hospital discharge.
Multimodal techniques for pain control have been recommended by The American Society of Anesthesiologists (ASA) for the management of acute postoperative pain. Traditional analgesia based on opioids have multiple adverse effects such as respiratory depression, nausea, vomiting, itching and dizziness.
SAP block was first described in 2013 by Blanco as an analgesic technique.it is proposed to block the lateral cutaneous branch of the intercostal nerve, long thoracic nerve, and dorsal thoracic nerve. The block range of the SAPB covers the incisions of video-assisted thoracoscopic surgery (VATS) and the site of the chest tube, which are often located in the antero-lateral chest wall. The local anaesthetic injection was described in two planes: the 'superficial plane' and deep plane.
An ultrasound-guided ESP block was firstly reported in 2016. The ESP block injects a local anaesthetic around the erector spinae muscle at approximately the level of the T5. It may be able to block the dorsal and ventral rami of the thoracic spinal nerves. The first report of the successful use of this procedure was in 2016; the block was used to manage thoracic neuropathic pain in a patient with metastatic disease of the ribs and rib fractures
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: abdallah M soudi, M.D.56k
- Phone Number: +201111228925
- Email: Dr.soudi2014@med.asu.edu.eg
Study Locations
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-
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Cairo, Egypt, 02
- Recruiting
- Faculty of medicine ain shams university
-
Contact:
- abdallah soudi
- Phone Number: 01111228925
- Email: Dr.soudi2014@med.asu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- body mass index (BMI)=18 to 40 kg/m2
Exclusion Criteria:
- Contraindications to regional anesthesia as bleeding disorders , allergy to local anesthetic or infection at block site
- pre-existing chronic pain
- history of opiate abuse
- sepsis
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: Group A: Erector spinae block group
After selecting the target transverse process for the nerve block, place the transducer in a paramedian sagittal orientation, approximately 2cm away from the midline (spinous processes), and try to vizualize the transverse process at the level of T5 Complete the nerve block with 30ml of 0.25% levobupivacaine for erector spinae block
|
30ml of 0.25% levobupivacaine for erector spinae block at level of T5
|
|
Active Comparator: group B: Serratus anterior block group
High-frequency linear transducer should be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized. Then, using ultrasound guidance, the needle is advanced in-plane and the local anesthetic is injected anteriorly to the rib and deep to the serratus anterior. After opening the fascial plane, a volume of dilute local anesthetic, 30 mL of 0.25% levobupivacaine, should be gradually injected. |
30 mL of 0.25% levobupivacaine injected anteriorly to the rib and deep to the serratus anterior at level of 5 th rib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post operative opioid consumption
Time Frame: 24 hours post operative
|
post operative meperidine consumption throughout
|
24 hours post operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
intraoperative fentanyl consumption
Time Frame: during the surgery
|
total introperative fentanyl dose
|
during the surgery
|
|
the numerical rating scale
Time Frame: 24 hours post operative
|
a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 to 10 integers) that best reflects the intensity of their pain.
0 representing one pain extreme (e.g., "no pain") and 10 representing the other pain extreme (e.g., "pain as bad as you can imagine" and "worst pain imaginable")
|
24 hours post operative
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- FMASU MS 145/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
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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