Antalya City Hospital
Antalya, Turkey (Türkiye)
NCT Number: NCT07553195
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) and Deep Serratus Anterior Plane Block in patients undergoing Video-Assisted Thoracoscopic Surgery. The primary outcome is Visual Analog Scale (VAS) during the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block performance time, block-related and systemic side effects (hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, infection), Patient satisfaction assessed using a Likert scale, Quality of recovery assessed using the QoR-15 questionnaire.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Not applicable
Antalya, Turkey (Türkiye)
Study Objective
This research aims to obtain objective data to demonstrate the effectiveness of two regional block techniques in acute pain management. The primary objective is to compare the effects of Serratus Posterior Superior Intercostal Plane (SPSIP) and Deep Serratus Anterior Plane Block on Visual Analog Scale (VAS) scores in patients undergoing Video-Assisted Thoracoscopic Surgery. Secondary outcomes include evaluating the impact of these blocks on total opioid consumption within the first 24 hours and postoperative recovery quality.
Materials and Methods:
This prospective, randomized clinical study will include voluntary patients aged 18-65 years, classified as American Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI) <35 kg/m². All participants will be informed about the study protocol in detail, and written informed consent will be obtained prior to inclusion. Patients will receive instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10 denotes the worst imaginable pain.
Patients who meet the exclusion criteria will be withdrawn from the study. Participants will be randomly assigned to one of two groups using a computer-generated simple randomization method (https://www.randomizer.org). Randomization will be performed by a team member uninvolved in patient care, who will also prepare sealed opaque envelopes to conceal group allocation until shortly before block administration.The patients and the outcome assessors were blinded to group allocation. The anesthesiologist performing the block was not involved in postoperative data collection and was not blinded due to the nature of the intervention.
Study Groups and Block Procedures: Group SPSIP will receive a unilateral SPSIP block, and Group Deep Serratus Anterior Plane will receive a unilateral Deep SAP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure prior to the block. Premedication with intravenous midazolam (0.02 mg/kg) will be administered.
SPSIP Block:
The Serratus Posterior Superior Intercostal Plane (SPSIP) block will be performed 30 minutes prior to surgery with the patient in a sitting position. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned along the medial border of the scapula at the level of the second and third ribs on the surgical side.
Anatomical landmarks, including the trapezius, rhomboid major muscle (RMM), serratus posterior superior muscle (SPSM), intercostal muscles, the second and third ribs will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be inserted into the fascial plane between the SPSM and underlying intercostal muscles over the third rib. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 30 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered.
The block performance time, defined as the duration from initial ultrasound probe contact with the skin to the final withdrawal of the needle following injection, will be recorded.
Deep SAP :
The Deep Serratus Anterior Plane Block (Deep SAP) will be performed 30 minutes prior to surgery with the patient in the supine position with the arm abducted to 90°. After skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be placed sagittally on the clavicle and counted the ribs downwards and laterally until the 5th intercostal space in the mid-axillary line. Sonographic landmarks were identified along the mid-axillary line, including the latissimus dorsi muscle, serratus anterior muscle, intercostal muscles, ribs, and pleura on the surgical side.
Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle (Echoplex®+, Vygon SA, Écouen, France) will be inserted into the fascial plane between the serratus anterior muscle and the external intercostal muscles at the level of the 5th rib in the mid-axillary line.. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 30 mL of 0.25% bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered.
The block performance time, defined as the duration from initial ultrasound probe contact with the skin to the final withdrawal of the needle following injection, will be recorded.
General Anesthesia Upon entry into the operating room, patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO₂), and non-invasive blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide (0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).
Anesthesia maintenance will be provided using 6% desflurane in a 40% oxygen-air mixture and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO₂ maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the remifentanil dose will be titrated accordingly.
Thirty minutes before the end of surgery, all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®, Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of intravenous tramadol. To prevent nausea and vomiting, 0.15 mg/kg of intravenous ondansetron will be administered. Patients with adequate spontaneous ventilation will be extubated and transferred to the post-anesthesia care unit (PACU).
Hemodynamic Monitoring Heart rate, systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen saturation will be recorded at the following time points: pre-induction (baseline), 5 minutes after induction, 5 minutes after surgical incision, 15 minutes after incision, and at the end of surgery.
Postoperative Pain and Analgesic Use Pain will be assessed using the VAS at rest (static) and pain during coughing at 0, 1, 4, 8, 12, and 24 hours postoperatively. All patients will use patient-controlled analgesia (PCA) without a basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL concentration) with a 10-minute lockout interval. Patients will be instructed to press the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours. Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be recorded.
Postoperative Recovery Quality Postoperative recovery will be assessed using the 15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains: pain, physical comfort, physical independence, psychological support, and emotional state.
Patient and Surgeon Satisfaction Satisfaction will be evaluated using a 5-point Likert scale, where 1 = not satisfied and 5 = very satisfied, based on verbal feedback from both the patient and the surgeon.
Shoulder pain will be assessed at 0, 1, 4, 8, 12, and 24 hours postoperatively using a numeric rating scale (NRS, 0-10). The incidence and severity of ipsilateral shoulder pain will be recorded.
Nausea and Vomiting
Nausea and vomiting will be scored using a 4-point scale:
0 = none
Potential Complications Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic toxicity, vascular puncture, or infection) will be recorded.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients in this group will receive an ultrasound-guided Serratus Posterior Superior Intercostal Plane (SPSIP) block with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus posterior superior muscle and the third rib, 30 minutes before surgery.
Patients in this group will receive an ultrasound-guided Deep Serratus Anterior Plane Block (Deep SAP) with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the serratus anterior muscle and the external intercostal muscles at the level of the 5th rib in the mid-axillary line.
Time frame: 0, 1, 4, 8, 12, and 24 hours after surgery
Postoperative pain intensity (VAS score) Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity. Measurements will be recorded at predefined time points within the first 24 hours after surgery.
Time frame: Within the first 24 hours postoperatively
Time frame: Within the first 24 hours postoperatively
Time frame: During the block procedure (intraoperative period)
Time frame: Within the first 24 hours postoperatively
Time frame: At 24 hours postoperatively
Patient and surgeon satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction. Assessment will be performed at 24 hours postoperatively.
Time frame: At 24 hours postoperatively
Quality of recovery will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire, which ranges from 0 to 150, with higher scores indicating better recovery. Assessment will be performed at 24 hours postoperatively.
Time frame: At 24 hours postoperatively
Time frame: within the first 24 hours after surgery (0, 1, 4, 8, 12, and 24 hours)
Postoperative shoulder pain will be assessed using the Visual Analog Scala(VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Contact information is provided by the study sponsor or research team.
Antalya City Hospital
Other
Comparison of Serratus Posterior Superior Intercostal Plane Block and Deep Serratus Anterior Plane Block After Video-Assisted Thoracoscopic Surgery: A Randomized Controlled Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07540104
Agnosia, Nervous System Diseases
Atakent, Samsun, Turkey (Türkiye)
View Trial DetailsNCT07238621
Anterior Cervical Discectomy, Cervical Disc Herniation
Sivas, Turkey (Türkiye)
View Trial DetailsNCT07073495
Edge Laminar Block, Neurologic Manifestations
Ankara, Turkey (Türkiye)
View Trial DetailsNCT06407037
Acute Pain, Breast Diseases
Yenimahalle, Ankara, Turkey (Türkiye)
View Trial Details