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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Bilateral Thoracic Erector spinae plane block (ESPB).; Procedure: Bilateral Modified Pectoral Nerve Block (PECS II).

• Registration Number: NCT06478654
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Status Verified: 2024-02
• Study Start: 2024-03-01
• Study First Submitted: 2024-06-23
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-06-27
• Primary Completion: 2024-09-01
• Study Completion: 2024-10-01
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II	Bilateral Thoracic Erector spinae plane block (ESPB).	Group II 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
Group I	Bilateral Modified Pectoral Nerve Block (PECS II).	Group I 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.

Primary Outcome Measures

Name	Time	Method
the time interval from end of the block technique to first supplemental dose of analgesia in hours.	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 Outcome Measures

Name	Time	Method
Total morphine doses in mg.	24 hours	Total morphine consumption in 24 hours postoperative will be calculated

Trial Locations

Locations (1)

Yasmeen mohamed; 🇪🇬 Cairo, Egypt