Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Primary Purpose
Pain, Postoperative
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Serratus anterior plane block
Erector spinae block
Sponsored by
About this trial
This is an interventional supportive care trial for Pain, Postoperative
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Serratus anterior block
Erector spinae block
Arm Description
Regional analgesic block of anterolateral chest wall
Regional analgesic block for the whole chest wall
Outcomes
Primary Outcome Measures
the duration till 1st requirement of analgesia
The time from the end of the operation till Visual analogue score more than 3
Secondary Outcome Measures
Analgesic consumption
Total analgesic opioid consumption during the first postoperative day
Full Information
NCT ID
NCT05218746
First Posted
January 31, 2022
Last Updated
February 11, 2022
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05218746
Brief Title
Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Official Title
Comparison Between Serratus Anterior Plane Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to compare serratus anterior plane block and erector spinae plane block for postoperative analgesia after VATS as measured by the duration till 1st requirement of analgesia.
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Serratus anterior block
Arm Type
Experimental
Arm Description
Regional analgesic block of anterolateral chest wall
Arm Title
Erector spinae block
Arm Type
Experimental
Arm Description
Regional analgesic block for the whole chest wall
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Erector spinae block
Intervention Description
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.
Primary Outcome Measure Information:
Title
the duration till 1st requirement of analgesia
Description
The time from the end of the operation till Visual analogue score more than 3
Time Frame
postoperative first day
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
Total analgesic opioid consumption during the first postoperative day
Time Frame
postoperative first day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Regional Blocks for Postoperative Analgesia After Video-Assisted Thoracoscopic Surgery
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