Trial Title:
SPSIPB vs SAPB for Thoracoscopic Surgery
NCT ID:
NCT06546839
Condition:
Lung Diseases
Lung Cancer
Lung Neoplasms
Lung Cancer Metastatic
Thoracic Diseases
Thoracic Cancer
Thoracic Neoplasms
Conditions: Official terms:
Lung Neoplasms
Neoplasms
Thoracic Neoplasms
Lung Diseases
Thoracic Diseases
Aortic Dissection
Conditions: Keywords:
Video assisted thoracic surgery
Postoperative analgesia management
Serratus anterior plane block
Serratus Posterior Superior Interfascial Plane Block
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Double (Participant, Outcomes Assessor)
Masking description:
The anesthesiologist who performs postoperative pain evaluation and the patient will not
know the group.
Intervention:
Intervention type:
Drug
Intervention name:
SPSIPB blcok
Description:
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.
Arm group label:
Group SPSIPB = SPSIPB group
Intervention type:
Drug
Intervention name:
SAPB block
Description:
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.
Arm group label:
Group SAPB = SAPB group
Intervention type:
Drug
Intervention name:
Postoperative analgesia management
Description:
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.
Arm group label:
Group SAPB = SAPB group
Arm group label:
Group SPSIPB = SPSIPB group
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Istanbul Medipol University Hospital
Address:
City:
Istanbul
Zip:
34070
Country:
Turkey
Status:
Recruiting
Contact:
Last name:
Bahadir Ciftci, MD
Phone:
+905325034428
Email:
bciftci@medipol.edu.tr
Start date:
August 10, 2024
Completion date:
November 25, 2024
Lead sponsor:
Agency:
Medipol University
Agency class:
Other
Source:
Medipol University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06546839
