- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07553208
SPSIP vs ESP Block for Analgesia After Rib Fracture Surgery
Ultrasound-guided Serratus Posterior Superior Intercostal Plane Block Versus Erector Spinae Plane Block for Postoperative Analgesia After Surgical Stabilization of Rib Fractures: a Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
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Patients who meet the exclusion criteria will be withdrawn from the study.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
- mild
- moderate
- severe
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MUSTAFA KILIN, CONSULTANT ANESTHESİOLOGİST
- Phone Number: +905464569218
- Email: mustafa.kilin90@gmail.com
Study Locations
-
-
-
Antalya, Turkey (Türkiye)
- Antalya City Hospitial, Ministry of Health, Turkey
-
Contact:
- MUSTAFA KILIN, CONSULTANT ANESTHESİOLOGİST
- Phone Number: +905464569218
- Email: mustafa.kilin90@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective video-assisted thoracoscopic surgery
- Body mass index (BMI) between 18 and 35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
- Ability to provide written informed consent
Exclusion Criteria:
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Body mass index (BMI) <18 or >35 kg/m²
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Serratus Posterior Superior Intercostal Plane Block (SPSIP)
Serratus Posterior Superior Intercostal Plane
|
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.
|
|
Active Comparator: Erector Spinae Plane Block (ESP)
Erector Spinae Plane Block
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity assessed using the Visual Analog Scale (VAS)
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.
|
0, 1, 4, 8, 12, and 24 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Requirement for rescue analgesia
Time Frame: Within the first 24 hours postoperatively
|
Within the first 24 hours postoperatively
|
|
|
Block performance time
Time Frame: During the block procedure (intraoperative period)
|
During the block procedure (intraoperative period)
|
|
|
Block-related and systemic side effects
Time Frame: Within the first 24 hours postoperatively
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Within the first 24 hours postoperatively
|
|
|
Patient and Surgeon satisfaction assessed using a Likert scale
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.
|
At 24 hours postoperatively
|
|
Quality of recovery assessed using the QoR-15 questionnaire
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.
|
At 24 hours postoperatively
|
|
Total opioid consumption via patient-controlled analgesia (PCA)
Time Frame: Within the first 24 hours postoperatively
|
Within the first 24 hours postoperatively
|
|
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İncedence of postoperative nausea and vomiting(PONV)
Time Frame: At 24 hours postoperatively
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At 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: MUSTAFA KILIN, ANTALYA CİTY HOSPİTAL, MİNİSTRY OF HEALTH, TURKEY
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- esp-spsıp-Rib
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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