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Video-assisted Thoracoscopic SurgeryNCT06219369

Effecot of Serratus Posterior Superior Intercostal Plane Block and Thoracic Paravertebral Block in VATS

A study testing Group T in people with Video-assisted Thoracoscopic Surgery, run by Hitit University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Video-assisted Thoracoscopic Surgery
What is being tested?
Group T
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
31 Jan 2024to 15 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A minimum of 70 patients who will undergo VATS surgery,
  • American Society of Anesthesiologists (ASA) physical classification 1-2-3,
  • Aged between 18-65,
  • Who have read and accepted the voluntary informed consent form,
  • Body mass index (BMI) of <35.

Who cannot join

  • Patients who refuse to participate in the study,
  • BMI >35,
  • ASA physical classifications 4-5,
  • Patients unable to perform pain scoring using the NRS system,
  • Those allergic to the administered local anesthetic and designated analgesic medication, individuals declaring pregnancy or lactation,
  • Patients under 18 or over 65 years of age,
Show all 20Show fewer
  • Uncontrollable anxiety,
  • Alcohol and drug addiction,
  • Neuromuscular and peripheral nerve diseases,
  • Using high doses of opioid medication three days before surgery,
  • Widespread chronic pain,
  • Diabetes mellitus,
  • Hepatic and renal insufficiency,
  • Coagulation disorders,
  • Using anticoagulant drugs,
  • Infection at the site of peripheral block needle insertion,
  • History of abdominal surgery or trauma,
  • Unable to communicate in Turkish,
  • Patients experiencing technical problems while using patient-controlled analgesia,
  • Patients for whom the surgical procedure needs to be terminated for any reason before completion, as well as those for whom postoperative extubation is not planned, will not be accepted into the study.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Hitit university

    Çorum, Çorum, 19100

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Postoperative Analgesic Efficacy of Serratus Posterior Superior Intercostal Plane Block and Thoracic Paravertebral Block in Patients Undergoing Video-Assisted Thoracoscopic Surgery

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\&#39; 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 Visual analog score (VAS), time to first rescue analgesia, opioid consumption, postoperative nausea and vomiting (PONV) score, and complications, and to determine which one is more effective.

Read the detailed 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\&#39;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) \&lt;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 \&gt;35, ASA 4-5 classification, inability to score pain using the Visual analog score (VAS) 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\&#39;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\&#39;s mean arterial blood pressure within 20% of the baseline value. The patient\&#39;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\&#39;s group information, will be performed by an

Being tested
Group T
Keywords
thoracic paravertebral block, VATS, serratus posterior superior interkostal plane block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group TProcedure or surgery

    Also called Group S

    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.

    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.

Study groups in NCT06219369
Study groupRoleWhat they receive
Group TActive comparatorGroup T patients who underwent TPVB
Receives: Procedure: Group T
Group SActive comparatorGroup S patients who underwent SPSIPB
Receives: Procedure: Group T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperatative Pain

    Evaluation of patients' post-operative pain levels

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2024
  2. Study start31 Jan 2024
  3. Primary completion20 May 2024
  4. Study completion15 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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. 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.
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06219369
Sponsor's protocol ID
Hitit
Status last verified
Jan 2025
First submitted
29 Dec 2023
Last updated
6 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: not necessary

Publications

  • Dogan G, Kucuk O, Kayir S, Dal GC, Ciftci B, Zengin M, Alagoz A. Serratus posterior superior intercostal plane block versus thoracic paravertebral block for pain management after video-assisted thoracoscopic surgery: a randomized prospective study. Braz J Anesthesiol. 2025 Sep-Oct;75(5):844647. doi: 10.1016/j.bjane.2025.844647. Epub 2025 Jun 3.

    PubMed 40473018

Questions about this trial

What is this clinical trial studying?

A study testing Group T in people with Video-assisted Thoracoscopic Surgery, run by Hitit University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperatative Pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06219369, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.

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