- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06546839
SPSIPB vs SAPB for Thoracoscopic Surgery
Comparison of Serratus Posterior Superior Interfacial Plane Block vs Serratus Anterior Plane Block on Postoperative Analgesia in Patients Underwent Video-Assisted Thoracoscopic Surgery: A Randomized, Prospective, Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Video-assisted thoracic surgery (VATS) has started to be considered the standard surgical procedure for lung surgery in recent years. The advantages of VATS compared to open thoracotomy are rapid recovery, shorter hospital stays, and low risk of complications. Although it is a less painful surgical procedure compared to thoracotomy, severe acute postoperative pain can be observed especially in the first hours after VATS. Thoracic epidural analgesia (TEA), which is the gold standard for post-thoracotomy analgesia, is used in analgesia after VATS. However, due to the difference in surgical technique and trauma between open surgery and VATS, what should be the gold standard for analgesia after VATS is a matter of debate. It is supported that less invasive analgesic techniques should be applied for minimally invasive surgical procedures, especially due to the difficulty of applying TEA and its side-effect profile. Thoracic paravertebral block (TPVB) is considered the first-line regional technique for VATS surgery. However, it is difficult to apply due to its anatomical proximity to important structures such as the pleura and central neuraxial system, and it may cause complications such as pneumothorax and vascular injury. Analgesia management is very important in these patients, as insufficient analgesia in the postoperative period may cause pulmonary complications such as atelectasis, pneumonia, and increased oxygen consumption.
Ultrasound (US) guided serratus posterior superior block (SPSPB) is a new interfacial plane block defined by Tulgar et al in 2023. It is based on injection on the serratus posterior superior muscle at the level of the 2nd or 3rd rib. This block provides analgesia in conditions such as interscapular pain, chronic myofascial pain syndromes, scapulocostal syndrome, and shoulder pain. The SPS muscle is located at the C7-T2 level. It attaches to the lateral edges of the second and fifth ribs. It is innervated by the lower cervical and upper intercostal nerves. With the SPS block, these nerves are blocked and analgesia is provided.
In the cadaveric study of Tulgar et al., it was determined that the spread of serratus posterior superior interfacial plane block; 7-10 intercostal levels on the left side only in the superficial fascia of the trapezius muscle. Spread dye was observed at intercostal levels, absent on the right. There was prominent staining on both sides of the deep trapezius muscle. Both the surface and skin of the rhomboid major were stained, while the rhomboid minor was only stained in the skin. SPSP block will provide successful analgesia in procedures involving the thoracic region such as chronic myofascial pain, breast surgery, thoracic surgery, and shoulder surgery. There is no randomized study in the literature evaluating the effectiveness of SPSP block for postoperative analgesia management after VATS.
US-guided serratus anterior plane (SAP) block is an interfascial plane block and was described by Blanco in 2013. A local anesthetic solution is performed into the fascial plane of the serratus anterior muscle. It is easy to perform and has low complication rate because it is far away from the important neurological and vascular structures. The serratus anterior muscle may be seen easily with US guidance in the mid-axillary line. It provides effective analgesia in anterior, posterior, and lateral dermatomes of the thorax. It has been reported that SAP block provides effective postoperative pain management following thoracotomy, breast surgery, and VATS. There is no clinical randomized study in the literature evaluating the efficacy of SPSIPB and SAP block following VATS.
This study aims to compare US-guided SPSIPB and SAP block for postoperative analgesia management after VATS. The primary aim is to compare postoperative opioid consumption and the secondary aims are to evaluate postoperative pain scores (NRS), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to blocks (pneumothorax, hematoma).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey, 34070
- Istanbul Medipol University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-III
- Scheduled for VATS under general anesthesia
Exclusion Criteria:
history of bleeding diathesis, receiving anticoagulant treatment, known local anesthetics and opioid allergy, infection of the skin at the site of the needle puncture, pregnancy or lactation, patients who do not accept the procedure
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 SPSIPB = SPSIPB group
SPSIPB will be performed
|
A high-frequency linear US probe (11-12 MHz, Vivid Q) will be covered with a sterile sheath, and an 80 mm block needle (Braun 360°) will be used.
The procedure will be performed with the patient in the lateral decubitus position.
After the scapula is shifted slightly laterally, the US probe is placed sagittal at the upper corner of the spina scapula, and the serratus posterior superior muscle is visualized with the third rib.
The in-plane technique will be used.
The block needle will be advanced in the craniocaudal direction to enter between the serratus posterior superior and the third rib.
The block location will be confirmed by injecting 5 ml of saline between the rib and the muscle.
After the block location is confirmed, 30 ml of 0.25% concentration bupivacaine will be used.
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit.
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
|
|
Active Comparator: Group SAPB = SAPB group
SAPB will be performed
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient-controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol including 10 mcg bolus without infusion dose, 10 min lockout time, and 4-hour limit.
If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
In the lateral decubitus position, US probe will be placed in a sagittal plane over the midclavicular region of the thoracic cage.
Then the 7th rib will be identified in the midaxillary line, followed by the identification of the following muscles overlying the 6th rib: the latissimus dorsi (superficial and posterior), teres major (superior), and serratus muscle (deep and inferior).
The needle will be inserted in-plane concerning the ultrasound probe targeting the plane superficial to the serratus anterior muscle.
5 ml saline will be injected for correction.
Following confirmation of the correct position of the needle, 30 ml %0.25 bupivacaine will be administered for the block.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Opioid consumption (Fentanyl PCA)
Time Frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
|
The primary aim is to compare postoperative opioid consumption from the PCA device.
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Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Need for rescue analgesia (meperidine)
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare rescue analgesia used in the postoperative 24 h.
|
Postoperative 24 hours period
|
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Pain scores (Numerical rating scale-NRS)
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
The secondary aim is to compare NRS at the postoperative 24 h.
Postoperative pain assessment will be performed using the NRS (0 = no pain, 10 = the most severe pain felt).
The NRS scores will be recorded
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Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
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Adverse events
Time Frame: Postoperative 24 hours period
|
The secondary aim is to compare the adverse events (nausea, vomiting, itching) related to opioid use
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Postoperative 24 hours period
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block for breast surgery: a report of three cases, novel block and new indication. Minerva Anestesiol. 2023 Nov;89(11):1054-1056. doi: 10.23736/S0375-9393.23.17432-3. Epub 2023 Jun 1. No abstract available.
- Ciftci B, Alver S, Ahiskalioglu A, Bilal B, Tulgar S. Serratus posterior superior intercostal plane block: novel thoracic paraspinal block for thoracoscopic and shoulder surgery. Minerva Anestesiol. 2024 Apr;90(4):345-347. doi: 10.23736/S0375-9393.23.17827-8. Epub 2024 Jan 19. No abstract available.
- Avci O, Gundogdu O, Balci F, Tekcan MN, Ozbey M. Efficacy of serratus posterior superior intercostal plane block (SPSIPB) on post-operative pain and total analgesic consumption in patients undergoing video-assisted thoracoscopic surgery (VATS): A double-blinded randomised controlled trial. Indian J Anaesth. 2023 Dec;67(12):1116-1122. doi: 10.4103/ija.ija_589_23. Epub 2023 Dec 13.
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Medipol Hospital 38
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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