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Completed

NCT Number: NCT06478654

Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries

The aim of this study is to evaluate The Effectiveness of Ultrasound Guided Modified Pectoral Nerve Block (PECS II) versus Thoracic Erector Spinae Plane Block (ESPB) for postoperative Analgesia in cases of aesthetic breast surgeries.

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Key information

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yasmeen mohamed

Cairo, Egypt

About this study

Preoperative settings:

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females aged ≥21 years' old.
  • BMI ≤35.
  • Patients with ASA I & II.
  • Scheduled for one of the aesthetic breast surgeries.

Exclusion criteria

  • Patients refusal.
  • 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.

Treatment and study plan

Bilateral Modified Pectoral Nerve Block (PECS II).

Procedure

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).

Procedure

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.

Primary outcomes

  1. the time interval from end of the block technique to first supplemental dose of analgesia in hours.

    Time frame: 24 hours

    Postoperative pain will be evaluated by Numeric Rating Scale for pain (NRS Pain) which is a 11 point scale divided as 0=no pain,1-3(mild pain), 4-7(moderate pain) and 7-10(severe pain), 0-10 scale will be recorded by the main investigator at PACU, 2, 4, 8, 12,18 and 24 hours postoperatively.

    First rescue analgesia will be given with Injection Morphine sulfate (0.1mg/kg) IV when numerical rating scale score is equal to or more than 4. If the patient requires second dose of rescue analgesia only half of the original dose of morphine is given taking into consideration the adverse effect of morphine

Secondary outcomes

  1. Total morphine doses in mg.

    Time frame: 24 hours

    Total morphine consumption in 24 hours postoperative will be calculated

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Ultrasound Guided Bilateral Modified Pectoral Nerve (PECS II) Block Vs Bilateral Thoracic Erector Spinae Plane (ESP) Block for Postoperative Analgesia for Aesthetic Breast Surgeries

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jun 27, 2024
Registry last updated
Dec 3, 2024

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.

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