- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07368413
Comparison of the Analgesic Efficacy of Erector Spinae Plane Block in Breast-Conserving Surgery Versus Serratus Anterior Block Combined With Additional Pecto-Intercostal II Block
Comparison of Analgesic Efficacy and Opioid Consumption of Erector Spinae Plane Block Versus Serratus Anterior Block With Additional Pecto-Intercostal II Block in Breast-Conserving Surgery
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Design and Methods The study planned to compare the effects of Erector Spinae Plane Block (ESPB) and Serratus Anterior Plane Block combined with Pectoral Nerve Block Type II (SAPB + PECS II) on intraoperative analgesia and postoperative opioid requirement in patients undergoing breast cancer surgery will be conducted at Kayseri City Hospital with voluntary participants.
________________________________________ Anesthesia and Block Procedures All patients will undergo surgery under general anesthesia. To provide intraoperative and postoperative analgesia, block procedures will be performed in the preoperative period before induction of general anesthesia by the same experienced anesthesiologist. The effectiveness of the blocks will be evaluated using the pinprick test following the procedure.
Group 1: ESPB Technique Standard preoperative monitoring, including ECG, SpO₂, and non-invasive blood pressure (NIBP), will be applied under operating room conditions. Patients will be positioned in the lateral decubitus position with the operative side facing upward. A PHILIPS ClearVue 550 ultrasound device with a high-resolution linear probe (12-5 MHz) will be used. The probe and cable will be covered with a sterile sheath, sterile ultrasound gel will be applied, and skin antisepsis will be achieved using povidone-iodine.
The transverse process beneath the erector spinae muscle will be targeted. A 22G atraumatic, nerve stimulator-equipped block needle (B. Braun Stimuplex® Ultra 360, 0.7 × 80 mm) will be advanced in-plane from lateral to medial. After confirmation of correct placement by saline hydrodissection, 35 mL of 0.25% bupivacaine will be injected slowly, and longitudinal spread will be observed. Block success will be assessed using the pinprick test.
________________________________________ Group 2: SAPB + PECS II Technique Standard monitoring will be applied. Patients will be placed in the supine position with the ipsilateral arm abducted. Using the same ultrasound equipment, the PECS II block will be performed first. The needle will be advanced in-plane into the fascial plane between the pectoralis minor and serratus anterior muscles, and 15 mL of 0.25% bupivacaine will be injected after hydrodissection. Both blocks will be performed through a single skin puncture (single needle entry site); after the first injection, the needle will be redirected under ultrasound guidance to the serratus anterior plane for the subsequent injection. Subsequently, the SAPB will be performed at the level of the 5th or 6th rib, with the needle tip positioned beneath the serratus anterior muscle. After confirming the correct fascial plane, 20 mL of 0.25% bupivacaine will be injected. Block efficacy will be assessed using the pinprick test.
________________________________________ Intraoperative and Postoperative Management After induction with propofol (2-3 mg/kg), fentanyl (1-2 µg/kg), and rocuronium (0.6 mg/kg), anesthesia will be maintained with sevoflurane at 1 MAC and remifentanil infusion (0.05-0.25 µg/kg/min), adjusted according to hemodynamic parameters.
All patients will receive 1 g paracetamol and ondansetron 0.15 mg/kg IV intraoperatively.
Postoperatively, patients will be followed in the PACU for 30 minutes and connected to a morphine patient-controlled analgesia (PCA) device. Rescue analgesia and antiemetic protocols will be applied according to NRS and nausea-vomiting scale scores.
________________________________________ PCA Preparation The PCA solution will be prepared with 100 mg morphine diluted in 100 mL saline (1 mg/mL), without basal infusion. The lockout interval will be 15 minutes, and the maximum dose will be 4 mg per hour.
________________________________________ Data Analysis After completion of patient enrollment, collected data will be statistically analyzed and recorded.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Erdoğan Rahmi Çinçin, Resident Doctor
- Phone Number: +903523157700 +90538 862 31 08
- Email: erdo.cincin@gmail.com
Study Contact Backup
- Name: Çiğdem Ünal Kantekin, Associate Professor of Medicin
- Phone Number: +903523157700 +905054433056
- Email: drcgdm@gmail.com
Study Locations
-
-
Kocasinan
-
Kayseri, Kocasinan, Turkey (Türkiye), 38080
- Recruiting
- Kasyeri City Hospital
-
Contact:
- günhan gökahmetoğlu, Professor of Medicine
- Phone Number: +903523157700 +905336314488
- Email: gunhangok@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 75 years
- ASA physical status I-III
- No history of bleeding or coagulation disorders
- Absence of neuropathy
- Preoperative breast region NRS score < 4
Exclusion Criteria:
- systemic or regional infection
- known allergy to local anesthetics
- Unwillingness to participate in the study
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: Erector Spinae Plane Block
Standard preoperative monitoring, including ECG, SpO₂, and non-invasive blood pressure (NIBP), will be applied under operating room conditions. Patients will be positioned in the lateral decubitus position with the operative side facing upward. A PHILIPS ClearVue 550 ultrasound device with a high-resolution linear probe (12-5 MHz) will be used. The probe and cable will be covered with a sterile sheath, sterile ultrasound gel will be applied, and skin antisepsis will be achieved using povidone-iodine. The transverse process beneath the erector spinae muscle will be targeted. A 22G atraumatic, nerve stimulator-equipped block needle (B. Braun Stimuplex® Ultra 360, 0.7 × 80 mm) will be advanced in-plane from lateral to medial. After confirmation of correct placement by saline hydrodissection, 35 mL of 0.25% bupivacaine will be injected slowly, and longitudinal spread will be observed. Block success will be assessed using the pinprick test. |
Investigators will perform the block before the patient receives general anesthesia and investigators will check it with the pinprick test.
|
|
Active Comparator: SAPB + PECS II Technique
Standard monitoring will be applied.
Patients will be placed in the supine position with the ipsilateral arm abducted.
Using the same ultrasound equipment, the PECS II block will be performed first.
The needle will be advanced in-plane between the pectoralis minor and serratus anterior muscles, and 15 mL of 0.25% bupivacaine will be injected after hydrodissection.
Both blocks will be performed through a single skin puncture (single needle entry site); without withdrawing the needle from the skin, it will be redirected under ultrasound guidance to access the second target fascial plane.
Subsequently, the SAPB will be performed by advancing the probe to the 5th or 6th rib level.
The needle will be placed beneath the serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be injected following confirmation of the correct fascial plane.
Block efficacy will again be assessed using the pinprick test.
|
Investigators will perform both blocks with a single injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the Numerical Rating Scale
Time Frame: 24 hours or until the patient is discharged
|
The Numerical Rating Scale is a subjective pain assessment tool in which patients rate their pain intensity on a scale from 0 to 10, where 0 indicates no pain (the best/most favorable score) and 10 represents the worst pain imaginable (the worst/least favorable score)
|
24 hours or until the patient is discharged
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Nausea and Vomiting Scale
Time Frame: 24 hours or until the patient is discharged
|
Nausea and vomiting were assessed using the Nausea and Vomiting Scale, scored between 0 and 4 (0 = no symptoms [best/most favorable score], 1 = mild nausea, 2 = moderate nausea, 3 = frequent vomiting, approximately four episodes, 4 = continuous vomiting [worst/least favorable score]).
|
24 hours or until the patient is discharged
|
|
Apfel Risk Score
Time Frame: 24 hours or until the patient is discharged
|
The Apfel Risk Score is a simplified risk assessment tool used to predict postoperative nausea and vomiting (PONV).
It consists of four independent risk factors: female gender, non-smoking status, history of PONV or motion sickness, and planned postoperative opioid use.
The risk of PONV increases proportionally with the number of risk factors present.
|
24 hours or until the patient is discharged
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Çiğdem Ünal Kantekin, Associate Professor of Medicin, Kayseri City Hospital
Study record dates
Study Major Dates
Study Start (Actual)
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
- KayseriCH-AR-ERC-01
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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