Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries
NCT ID: NCT06478654
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2024-03-01
2024-10-01
Brief Summary
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Detailed Description
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All the patients will be fasting for solid food for at least 6 hours and for clear fluids for 4 hours before surgery and will be instructed about Numeric Rating Scale (NRS) and its interpretation.
Intravenous access will be inserted, premedication with midazolam 3 mg will be done. On arrival to operating room, routine monitoring including electrocardiography (ECG), non-invasive arterial blood pressure(NIBP) and pulse oximetry will be used. The mean arterial blood pressure (MAP)and heart rate (HR) will be recorded before induction of general anaesthesia (baseline).
Intraoperative \& postoperative settings :
A prophylactic antibiotic will be given after skin sensetivity test then General Intravenous anaesthesia induction will be done. Patient inductions by Propofol (2 mg/kg), Atracurium 0.5 mg/kg and Fentanyl 1 µg/kg. Endotracheal intubation will be settled then Patients will be mechanically ventilated and ventilator parameters will be set to keep end tidal CO2 between 30-35 mmHg guided by Capnogram. Anaesthesia will be maintained with Isoflurane 1,5 to 2 vol%. Patient will be given 50% oxygen/air mixture, and Incremental doses of fentanyl (0.5µg/kg) will be given every 1 hour. The depth of anaesthesia will be adjusted to keep changes of hemodynamics; (MAP) and (HR); within the range of ±20% of the baseline.
Under complete aseptic conditions, The blocks will be performed by a consultant anesthesiologist with a 5-year of experience in regional nerve blocks.
The blocks will be performed with a 20gauge, echogenic needle (Pajunk, 120mm, Germany).
The patients will be randomly divided into two groups,then the desired block will be done.
Surgical procedure will be started after performing the desired block.
At the end of surgery, Patients will be extubated after reversal of muscle relaxant by neostigmine 0.05 mg/kg with atropine 0.02 mg/kg. Patients will be transported to Post Anaesthesia care unit (PACU). HR, systolic, diastolic and mean pressures will be observed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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PECS II group
PECS II group will receive Bilateral Modified Pectoral Nerve Block (PECS II) Group Under all aseptic precautions and sonar guided.
10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine.
Bilateral Modified Pectoral Nerve Block (PECS II).
The procedure will be done bilateral with the patient lying in the supine position and the ipsilateral arm will be abducted and externally rotated, and the elbow flexed 90°.
The block will be managed by in-plane technique. After confirming the location of the needle with 2-3 mL of saline, 10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine
ESP group
ESP group will receive Bilateral Thoracic Erector spinae plane block (ESPB) Group.
Under all aseptic precautions and sonar guided. We will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine
Bilateral Thoracic Erector spinae plane block (ESPB).
Under all aseptic precautions and sonar guided, ESP block will be managed at T4 or T5 bilateral using a high-frequency linear ultrasound probeWe will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine.
Interventions
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Bilateral Modified Pectoral Nerve Block (PECS II).
The procedure will be done bilateral with the patient lying in the supine position and the ipsilateral arm will be abducted and externally rotated, and the elbow flexed 90°.
The block will be managed by in-plane technique. After confirming the location of the needle with 2-3 mL of saline, 10 mL of 0.25% bupivacaine will be injected. Then, the needle will be advanced to the interfascial plane between the pectoralis minor and serratus anterior muscle, and 20 mL of 0.25% bupivacaine will be administered with the same procedure. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine
Bilateral Thoracic Erector spinae plane block (ESPB).
Under all aseptic precautions and sonar guided, ESP block will be managed at T4 or T5 bilateral using a high-frequency linear ultrasound probeWe will inject 20ml of bupivacaine 0.25% into interfacial plane below to erector spinae, a manifest linear pattern will be visualized uplifting the muscle. The Block will be repeated on the other side using similar technique taking into consideration the toxic dose of bupivacaine.
Eligibility Criteria
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Inclusion Criteria
* BMI ≤35.
* Patients with ASA I \& II.
* Scheduled for one of the aesthetic breast surgeries.
Exclusion Criteria
* Contraindications to regional anaesthesia as bleeding disorders, spine deformity and local infection.
* Patients with unstable cardiovascular disease.
* Emergency surgery.
* Patients with chronic pain.
* History of allergy to the medications used in the study.
21 Years
FEMALE
Yes
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Principal Investigators
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Yasmeen Mohamed
Role: PRINCIPAL_INVESTIGATOR
Ainshams university, faculty of medicine
Locations
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Yasmeen mohamed
Cairo, , Egypt
Countries
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Other Identifiers
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FMASU MS77/2024
Identifier Type: -
Identifier Source: org_study_id