Modified Pectoral Nerve Block Versus Serratus Plane Block

NCT04895397 | Unknown

• 1 other identifier: soh-Med-21-02-05
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

In PECSII or modified PECSI block, local anesthetic (LA) is injected between pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) to block lateral and medial pectoral nerves and between pectoralis minor muscle (Pmm) and serratus anterior muscle in the anterior axillary line to block the intercostal nerves II-VI (Blanco et al., 2012). In Serratus anterior plane block (SAPB) local anesthetic (LA) is injected above the serratus muscle (between latissmus dorsi muscle and serratus muscle) or below the serratus muscle (between serratus muscle and 4th rib) in the mid-axillary line to block the intercostal nerves II-VI and spares the pectoral nerves (Blanco et al., 2013).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• assess analgesic effect of nerve block

  We assess the analgesic effect by VAS ( visual analogue scale )

  24hour post-operative

Study Arms (2)

Group A: (30 patients)

ACTIVE COMPARATOR

modified pectoral nerve block will be done.

Device: ultrasound guided Nerve Block procedure

Group B: (30 patients)

ACTIVE COMPARATOR

serratus plane block will be done.

Device: ultrasound guided Nerve Block procedure

Interventions

ultrasound guided Nerve Block procedure DEVICE

In group A patients, an ultrasound guided modified pectoral nerve block will be performed Under sterile conditions, US-guided PECSII block will be on the same side of surgery . The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally. the needle will be advanced in an in-plane technique targeting the space in which the artery is located. Afterward, 10 mL of bupivacaine, 0.25%, will be injected. the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected. Group B: In SAPB Group, a US-guided serratus block will be done The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane.

Group A: (30 patients); Group B: (30 patients)

Eligibility Criteria

• Age: 20 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Breast cancer surgery.
• Age 20 to 60 years.
• Female patients.
• At least 24 hours post-operative hospital admission.
• ASA (American society of anesthesiologist) physical status classification system І to Ш.

You may not qualify if:

• Morbid obesity (body mass index \> 40).
• Impossibility of anatomical structures identification by ultrasound in a satisfactory way (there can be no distinction in the interfacial plan between serratus and pectoral muscle).
• Opioids treatment before surgery or substance abuse.
• Sepsis and/or infection at the puncture site.
• Hemostasis disorders.
• Allergy to any of the drugs used in the study.
• Less than 24 hours postoperative hospital admission.
• Inability to communicate with the patient.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• mohammed hussein, lecturer

  Sohag University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

mohammed hussein, lecturer

CONTACT

01005872429; mohamedhussin@med.sohag.edu.eg

mohamed hussein, lecturer

CONTACT

01005872429; mohamedhussin@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Group A: (30 patients) modified pectoral nerve block will be done. Group B: (30 patients) serratus plane block will be done.

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 20, 2021
• Study Start: May 20, 2021
• Primary Completion: June 20, 2023
• Study Completion: August 20, 2023
• Last Updated: May 20, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share