Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06219369 |
| Other study ID # |
Hitit |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 31, 2024 |
| Est. completion date |
June 15, 2024 |
Study information
| Verified date |
February 2024 |
| Source |
Hitit University |
| Contact |
Guvenc Dogan, MD |
| Phone |
+905054025208 |
| Email |
guvencdogan[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Video-assisted thoracoscopic surgery (VATS) has become a standard procedure in both minor and
major lung surgeries in thoracic surgery operations. Although postoperative pain in patients
undergoing VATS is not as severe as that seen after thoracotomy, it still occurs. This, in
turn, affects postoperative pulmonary complications and patients' lengths of hospital
stay. Thoracic epidural analgesia (TEA) is still considered the gold standard in the
treatment of postoperative pain. However, due to side effects such as post-procedural
hypotension, urinary retention, or nausea/vomiting, alternative analgesic methods such as
thoracic paravertebral block (TPVB), intercostal block, serratus anterior plane block (SAPB),
erector spinae plane block (ESPB), and serratus posterior superior intercostal plane block
(SPSIPB) are being considered instead of epidural analgesia.
Among these methods, TPVB performed under ultrasound guidance is already a commonly preferred
and classical method. In patients undergoing thoracotomy and VATS, Tulgar and colleagues have
defined SPSIPB as a new technique and demonstrated its efficacy in providing analgesia in the
hemithorax when considering the sensory dermatome of SPSIPB in a cadaveric and a case series
study with five patients conducted in 2023. Similarly, Avcı and colleagues, in their article
published in 2023, emphasized the analgesic effectiveness of SPSIPB in the thoracic region
after VATS. As far as we know, there is no published study comparing TPVB and SPSIPB under
ultrasound guidance to date. Therefore, the aim of this study was to compare
ultrasound-guided TPVB and SPSIPB in postoperative analgesia after VATS. Our primary goal is
to investigate whether there are any superiority in terms of postoperative Numeric Rating
Scale (NRS) score, time to first rescue analgesia, opioid consumption, postoperative nausea
and vomiting (PONV) score, and complications, and to determine which one is more effective.
Description:
VATS (Video-Assisted Thoracoscopic Surgery) is based on the principle of performing surgical
procedures through two 2-3 cm skin incisions into the thorax with instruments inserted
through an endocamera placed in the thoracic cavity, and the images reflected on a monitor.
The procedure is carried out in operating room conditions under general anesthesia.
Collapsing the lung on the same side during the procedure allows exploration of the thoracic
cavity and facilitates the free movement of surgical instruments within the cavity. Patients
are placed in the lateral decubitus position on the operating table, and preparations are
made for posterolateral thoracotomy in case the method proves insufficient or complications
arise. A 2 cm skin incision is made at the 7th or 8th intercostal space (ICS) on the
mid-axillary line. After blunt dissections, muscles are passed through, and the parietal
pleura is opened. The lung collapses with the developing pneumothorax. Digital palpation
checks for pleural adhesions, and the endocamera is inserted into the thorax. After
exploration, the locations for the insertion of surgical instruments are determined for the
other ports. Depending on the lesion's localization, two or more ports are opened. VATS
has recently been considered a standard surgical procedure for lung surgery. Compared to open
thoracotomy, the advantages of VATS surgery include rapid recovery, shorter hospitalization,
and a lower risk of complications. Although VATS surgery is less painful than thoracotomy,
especially in the first hours after VATS surgery, severe acute postoperative pain can occur.
Thoracic epidural analgesia (TEA), the gold standard for post-thoracotomy analgesia, is also
used for VATS postoperative analgesia. However, due to differences in surgical technique and
trauma between open surgery and VATS, there is a debate about what the gold standard for
post-VATS analgesia should be. Especially due to the difficulty of TEA application and the
side effect profile of hypotension, urinary retention, or nausea/vomiting, there is support
for the application of less invasive analgesic techniques for minimally invasive surgical
procedures. Postoperative pain in patients undergoing VATS is observed, although not as
severe as post-thoracotomy pain. This, like in thoracotomy, affects postoperative pulmonary
complications and the length of hospitalization for patients. If postoperative acute pain is
not adequately treated, it can lead to chronic pain in the long run. In recent years,
regional anesthesia techniques are frequently applied to patients for pain management, in
addition to general anesthesia (GA). TPVB, ESPB, and SAPB are among the commonly used
regional anesthesia techniques in thoracic surgery. GA is the basic anesthesia method for
thoracic surgery. However, GA can only inhibit the cortical limbic system or the projection
system of the hypothalamic cortex. It cannot completely block the transmission of peripheral
noxious stimuli to the central nervous system or effectively prevent the intraoperative
stress response. Consequently, the intensive use of opioid analgesics accompanies GA. The
intense use of opioids leads to delayed extubation, respiratory depression, nausea, and
vomiting. Adding peripheral blocks such as TPVB and SPSIPB is expected to provide preemptive
analgesia, resulting in more stable hemodynamics and less intraoperative opioid use. TPVB has
long been a primary regional technique for VATS surgery in the literature. In addition,
SPSIPB performed under ultrasound guidance, defined by Tulgar and colleagues in 2023, has
become a routine interfacial plane block applied as needed. It is based on the injection
above 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, attaching to the lateral edges of the second and fifth ribs. It is innervated by the
lower cervical and upper intercostal nerves. Analgesia is provided by blocking these nerves
with SPSIPB. In a cadaver study conducted by Tulgar and colleagues, the spread of SPSIPB was
observed as staining in a speckled pattern only on the surface fascia of the trapezius muscle
at 7-10 intercostal levels on the left side, with no staining on the right side. Clear
staining was observed deep in the trapezius muscle on both sides. The deep and superficial
parts of the rhomboid major were clearly stained, while only the deep part of the rhomboid
minor was stained. It was emphasized that SPSIPB provides successful analgesia in procedures
involving the thoracic region, such as chronic myofascial pain, breast surgery, thoracic
surgery, and shoulder surgery.
Materials and Methods:
This study is a prospective, randomized, double-blind observational trial. A minimum of 70
patients, aged between 18 and 65, with a body mass index (BMI) <35, undergoing VATS
surgery at the Chest Surgery Service of Hitit University Faculty of Medicine Erol Olçok
Training and Research Hospital, and classified under the American Society of
Anesthesiologists (ASA) physical classification 1-2-3, who have read and accepted the
voluntary informed consent form, will be included. Patients will be randomly assigned to two
groups using a computer-based method. The study will be blinded for patients, surgeons, and
those monitoring postoperative pain. Group T (n=35) will consist of patients receiving TPVB,
and Group S (n=35) will include patients receiving SPSIPB.
Exclusion criteria:
Patients unwilling to participate in the study, those with BMI >35, ASA 4-5
classification, inability to score pain using the Numerical Rating Scale (NRS) system,
allergies to the local anesthetic and specified analgesic drugs, pregnant or breastfeeding
women, patients under 18 or over 65 years old, those with uncontrolled anxiety, alcohol or
drug dependence, neuromuscular or peripheral nerve diseases, high-dose opioid use 3 days
before surgery, widespread chronic pain, diabetes mellitus, hepatic and renal insufficiency,
coagulation disorders, and patients using anticoagulant drugs, as well as those with
infections at the site of peripheral block needle entry, a history of abdominal surgery or
trauma, inability to communicate in Turkish, technical problems while using
patient-controlled analgesia (PCA) during surgery, and patients for whom surgery needs to be
terminated before completion and those for whom postoperative extubation is not planned will
be excluded from the study.
Method:
Patients will be provided with the necessary information about the procedure, and written
consent will be obtained. Included patients will be randomly assigned to either Group T or
Group S according to a computerized randomization table created by a non-participating
researcher. Each patient will be assigned a random code for blinding, sealed in envelopes.
The anesthetist in the operating room will receive the relevant sealed envelope indicating
the block to be performed for each randomized patient. Patients, surgeons, and those
monitoring postoperative pain will be blinded to the patient's group information.
Patients will be taken to the operating room, where standard anesthesia monitoring will be
applied. (non-invasive arterial blood pressure measurement, heart rate, electrocardiography,
peripheral oxygen saturation measurement). A 20 G catheter will be placed for intravenous
access in the patient. The time of anesthesia initiation will be recorded. For premedication,
0.03 mg/kg midazolam will be administered to the patients, and after preoxygenation,
anesthesia induction will be performed with 2 mg/kg propofol and 1 mcg/kg fentanyl. After the
administration of 0.6 mg/kg rocuronium bromide IV and achieving muscle relaxation, intubation
will be performed with a double-lumen endotracheal tube. Mechanical ventilation will be
provided with pressure-controlled mode targeting an end-tidal CO2 value of 35-40 mmHg. During
anesthesia maintenance, O2/air mixture (FiO2: 0.40), sevoflurane (minimum alveolar
concentration 0.8-1), and IV remifentanil infusion will be used. Remifentanil infusion will
be planned to maintain the patient's mean arterial blood pressure within 20% of the
baseline value. The patient's intraoperative vital signs will be monitored as per routine
anesthesia protocol. As an intraoperative antiemetic, 4 mg ondansetron IV will be
administered. Thirty minutes before the end of the surgical procedure, 1 g of paracetamol
infusion and 1 mg/kg contramal IV infusion will be administered to all patients for analgesic
purposes. After the completion of the surgery, while maintaining the depth of anesthesia, the
regional anesthesia technique will be applied. All block procedures will be performed under
sterile conditions. The end time of the surgical procedure, the end time of anesthesia, the
time of block administration, and the time of anesthesia termination will be recorded.
SPSIPB Technique:
The SPSIPB block, which follows the guidelines we routinely use, will be performed after the
completion of the surgical procedure and before the patient wakes up. 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 a
lateral decubitus position. After gently shifting the scapula laterally, the US probe will be
held sagittally at the upper corner of the scapula spine, visualizing the 3rd rib and the
serratus posterior superior muscle. An in-plane technique will be used. The block needle will
be advanced cranio-caudally between the serratus posterior superior and the 3rd rib. Block
placement will be confirmed by injecting 5 ml of saline between the rib and muscle. After
confirming the block placement, 30 ml of 0.25% concentration marcain (bupivacaine) will be
used.
TPVB Technique:
The US probe (11-12 MHz, Vivid Q) will be placed 2-3 cm lateral to the T5 spinous process.
After visualizing the transverse process, the paravertebral area, internal intercostal
membrane, paravertebral space, and pleura, the needle will be advanced to the paravertebral
space using an in-plane technique. Hydrodissection with 5 ml of saline and pleural depression
will be performed in this area. After confirming the accuracy of the site, 30 ml of 0.25%
bupivacaine will be injected into this area.
After completing the designated block procedure, neuromuscular blockade will be reversed with
4 mg/kg sugammadex under 80% O2 ventilation. After confirming spontaneous eye opening, the
endotracheal tube will be removed, and patients will be transferred to the intensive care
unit for observation and close monitoring. Postoperative pain monitoring, blinded to the
patient's group information, will be performed by an
