An interventional study of Erector Spinae Plane Block (ESP) and Serratus Posterior Superior Intercostal Plane (SPSIP) in Rib Fracture, Postoperative Pain and Thoracic Trauma, sponsored by Antalya City Hospital. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Antalya City Hospital · Not applicable, Interventional, and Treatment
Among 13 studies in Rib Fractures with a site in Turkey — 3 open to participants now, 4 under way, none of them phase 3. Rib Fractures · Turkey.
Among the 13 studies in Rib Fractures with a site in Turkey, this one is the 7th largest by planned enrollment of the 12 interventional ones that give a count, is the only one that started in 2026, is one of 8 with no phase, and was the 11th registered.
126 studies on the registry are indexed under Rib Fractures; 28 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 92 interventional studies indexed under Rib Fractures.
Browse Rib Fractures studies →3 of the 13 studies in Rib Fractures with a site in Turkey are open now, in 1 country. Each count lists the studies.
Of the 13 Rib Fractures studies recruiting now, 9 (69%) set no upper age limit and 1 (8%) stop at 75 or younger; 0 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →13 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 1 started in 2026.
Median enrollment 61 across the 12 interventional studies, 151 across the 1 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
None of the 13 has an industry lead sponsor. The 8 most frequent:
Antalya City Hospital is the lead sponsor of 15 studies on the registry; 15 are open to participants now.
Antalya City Hospital has 1 study filed under Rib Fractures — fewer than ten, so there is no comparison to draw.
1 of the studies in Rib Fractures with a site in Turkey that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07238582Caner İşevi, MDEffectiveness of an Innovative Chest Stabilizer in Rib Fracture Treatment: Impact on Respiratory Function, Complications, and Clinical Outcomes | 2027-09-01 |
Among the 13 studies in Rib Fractures with a site in Turkey, from their registry updates:
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Serratus Posterior Superior Intercostal Plane (SPSIP) block and the Erector Spinae Plane (ESP) block in patients undergoing surgical stabilization of rib fractures. The primary outcome is the Visual Analog Scale (VAS) score within 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 systemic toxicity, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, and quality of recovery assessed using the QoR-15 questionnaire.
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 Erector Spinae Plane (ESP) block on Visual Analog Scale (VAS) scores in patients undergoing surgical stabilization of rib fractures. 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.
Study Groups and Block Procedures: Group SPSIP will receive a unilateral SPSIP block, and Group ESP will receive a unilateral ESP block. All patients will be monitored with electrocardiography, peripheral oxygen saturation (SpO#), 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), and 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 the third rip. 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.
ESP :
The Erector Spinae Plane Block (RIB) 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 spinous processs level of the fifth thoracic vertebrae on the surgical side.
Anatomical landmarks, including the trapezius muscle, rhomboid major muscle (RMM), erector spinal muscle and transverse processes of the fifth thoracic vertebrae 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 erector spinal muscle and fifth thoracic vertebrae. 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 (SpO#), 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 CO# 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 during movement (dynamic) 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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Serratus Posterior Superior Intercostal Plane
Procedure: Serratus Posterior Superior Intercostal Plane (SPSIP)
Erector Spinae Plane Block
Procedure: Erector Spinae Plane Block (ESP)
Patients in this group will receive an ultrasound-guided Erector Spinae Plane Block (ESP) with 30 mL of 0.25% bupivacaine hydrochloride injected into the fascial plane between the erector spinae muscle and the fifth vertebral transverse processes, 30 minutes before surgery.
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.
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
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: 0, 1, 4, 8, 12, and 24 hours after surgery
Total opioid consumption via patient-controlled analgesia (PCA)
Time frame: Within the first 24 hours postoperatively
Requirement for rescue analgesia
Time frame: Within the first 24 hours postoperatively
Block performance time
Time frame: During the block procedure (intraoperative period)
Block-related and systemic side effects
Time frame: Within the first 24 hours postoperatively
Patient and Surgeon satisfaction assessed using a Likert scale
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 assessed using the QoR-15 questionnaire
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
İncedence of postoperative nausea and vomiting(PONV)
Time frame: At 24 hours postoperatively
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 40 non-industry interventional studies with no phase under Rib Fractures, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 19 months is below that.
Counting every sponsor, half of 40 studies reached it within 23 months; a quarter within 15 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Antalya City Hospital