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

NCT06478654 | Completed

• 1 other identifier: FMASU MS77/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• the time interval from end of the block technique to first supplemental dose of analgesia in 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

  24 hours

Secondary Outcomes (1)

• Total morphine doses in mg.

  24 hours

Study Arms (2)

PECS II group

EXPERIMENTAL

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.

Procedure: Bilateral Modified Pectoral Nerve Block (PECS II).

ESP group

EXPERIMENTAL

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

Procedure: Bilateral Thoracic Erector spinae plane block (ESPB).

Interventions

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

PECS II group

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.

ESP group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Yasmeen mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Yasmeen Mohamed

  Ainshams university, faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2024
• First Posted: June 27, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: October 1, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Before 1/2025
• Access Criteria: Free

Locations

EG (1)