Clinical trial NCT06478654: Modified Pectoral Nerve Block Vs Thoracic Erector Spinae Plane Block for Analgesia for Aesthetic Breast Surgeries
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: the time interval from end of the block technique to first supplemental dose of analgesia in hours.
timeFrame: 24 hours
Secondary outcomes:
measure: Total morphine doses in mg.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Yasmeen mohamed
Study officials:
affiliation: Ainshams university, faculty of medicine
name: Yasmeen Mohamed
role: PRINCIPAL_INVESTIGATOR
References: