Clinical trial NCT06546839: SPSIPB vs SAPB for Thoracoscopic Surgery
Official title: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Diseases
Lung Cancer
Lung Neoplasms
Lung Cancer Metastatic
Thoracic Diseases
Thoracic Cancer
Thoracic Neoplasms
Keywords: Video assisted thoracic surgery
Postoperative analgesia management
Serratus anterior plane block
Serratus Posterior Superior Interfascial Plane Block
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There are two models for this study. The first group is the SPSIPB group. The second one is the SAPB group.
Primary purpose: TREATMENT

Brief summary: Video-assisted thoracic surgery (VATS) has recently been evaluated as the standard surgical procedure for lung surgery. Although VATS is less painful than thoracotomy, patients may feel severe pain during the first hours of the postoperative period. Analgesia management is very important for these patients in the postoperative period since insufficient analgesia can 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. It has been reported that SPSIPB provides effective analgesia after VATS. US-guided serratus anterior plane (SAP) block provides effective analgesia in the thorax's anterior, posterior, and lateral dermatomes. 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Opioid consumption (Fentanyl PCA)
timeFrame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
Secondary outcomes:
measure: Pain scores (Numerical rating scale-NRS)
timeFrame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
measure: Need for rescue analgesia (meperidine)
timeFrame: Postoperative 24 hours period
measure: Adverse events
timeFrame: Postoperative 24 hours period
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University Hospital
state: Bagcilar
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.