- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05218746
Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Comparison Between Serratus Anterior Plane Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Video-assisted thoracoscopic surgery has become the standard surgical procedure for both minor and major oncological lung surgery, as it is considered less invasive and equally effective compared with thoracotomy . However, it is a fact that pain following VATS can be severe and long-lasting. According to Homma et al., 18.8% of patients who undergo VATS present with persistent pain 2 months after surgery.
Serratus anterior plane block is a type of interfascial plane block that was defined by Blanco and his colleagues in 2013 .Ultrasound-guided SAPB has recently gained the interest of the anesthesiologists and pain physicians due to its efficacy, relative ease, single-injection method with limited side-effect profile.
The SAPB targets the lateral cutaneous branches of the thoracic intercostal nerves, which arise from the anterior rami of the thoracic spinal nerves and run in a neurovascular bundle immediately inferior to each rib. At the midaxillary line, the lateral cutaneous branches of the thoracic intercostal nerve traverse through the internal intercostal, external intercostal, and serratus anterior muscles innervating the musculature of the lateral thorax.These branches of the intercostal nerves, therefore, travel through the two potential spaces described above. Local anesthetic inserted into these planes will spread throughout the lateral chest wall, resulting in paresthesia of the T2 through T9 dermatomes of the anterolateral thorax.
Erector spinae plane block is an interfascial plane block that was defined by Forero and colleagues in 2016. Erector spinae plane block has a wide indication range for pain management of the thoracic, abdominal , lumbar, hip, and even shoulder areas . Erector spinae plane block is a paraspinal block that targets the dorsal and ventral rami so that it can provide analgesia in the anterolateral and posterior chest wall .
Erector spinae plane block emerged in recent years to be effective in reducing postoperative pain at 24 h, i.e. preoperative ESPB plus intravenous opioid reduced pain scores and opioid consumption after VATS when compared with intravenous fentanyl only .
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria
- Patients with American Society of Anesthesiologists (ASA) physical status 1-3 --
- scheduled for VATS .
Exclusion Criteria:
- ≤20 or ≥80 years old.
- Refusing to participate in the study .
- History of allergy to the medications used in the study.
- Contraindication to regional anesthesia (including coagulopathy and local infection).
- Severe hepatic impairement (serum protein < 3g/dl and serum bilirubin > 3mg/dl) .
- Renal dysfunction (as determined by creatinine levels greater than 2mg/dl or predicted creatinine clearance (CLcr)<50ml/min).
- Psychiatric disorder.
- Pregnancy.
- Body mass index (BMI) ≥40 or ≤18 kg/m2.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Serratus anterior block
Regional analgesic block of anterolateral chest wall
|
High-frequency linear transducer will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left.
With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, Then, using ultrasound guidance, the needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib .
one millileter normal saline will be injected to confirm placement and to hydro-dissect the fascial layers and open the potential space.
|
Experimental: Erector spinae block
Regional analgesic block for the whole chest wall
|
A high-frequency linear ultrasound probe will be placed in a longitudinal orientation 3 cm from the midline.
Once the erector spinae muscle and the transverse processes is identified, spinal needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the duration till 1st requirement of analgesia
Time Frame: postoperative first day
|
The time from the end of the operation till Visual analogue score more than 3
|
postoperative first day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesic consumption
Time Frame: postoperative first day
|
Total analgesic opioid consumption during the first postoperative day
|
postoperative first day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
- Regional blocks in VATS
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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