U/S Guided SAB VS U/S Guided SAB With Modified Pectoral Nerve Block in Modified Radical Mastectomy

NCT ID: NCT05006612

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-14
• Study Completion Date: 2021-08-23

Brief Summary

We hypothesize that ultrasound guided serratus anterior plane block Combined With Modified Pectoral Nerve Block is going to be more effective than Ultrasound guided Serratus anterior plane block alone in patients undergoing MRM as modified Pecs block involves the block of medial and lateral pectoral nerves which are spared in case of serratus block alone, resulting in reducing myofascial pain and opioid consumption.

Detailed Description

Ultrasound guided Serratus anterior plane block was introduced in 2013 for analgesia of breast and lateral thoracic wall surgery. At the axillary fossa, the intercostobrachialis nerve, lateral cutaneous branches of the intercostal nerves (T3-T9), long thoracic nerve, and thoracodorsal nerve are located in a compartment between the serratus anterior and the latissimus dorsi muscles, between the posterior and midaxillary lines at this plane local anesthetic will be injected . Complications of serratus anterior plane block include local anesthetic toxicity and pneumothorax , unfortunately medial and lateral pectoral nerves are preserved which are responsible for the myofacial pain .

The pectoral nerves (Pecs) block types I and II (Modified Pectoral block) , is less invasive technique described by Blanco et al where local anesthetic is deposited into the plane between the pectoralis major muscle(PMm) and the pectoralis minor muscle (Pmm) (Pecs I block)and above the serratus anterior muscle at the third rib (Pecs IIblock).,Blocking intercostobrachial, third to sixth intercostals the long thoracic nerves in addition to medial and lateral pectoral nerves.

Addition of Modified Pecs block to Serratus anterior plane block will enhance the control of pain as it block the medial and lateral pectoral nerves which are responsible for the myofacial pain and which are spared in case of Serratus block alone .

Conditions

U/S Guided SAB VS U/S Guided SAB Combined With Modified Pectoral Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group 1 ((Serratus Anterior Plane Block SAPB)

N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 30 ml levobupivacaine 0.25%.

Group Type: ACTIVE_COMPARATOR

Serratus Anterior Plane Block

Intervention Type: PROCEDURE

SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle.

SAPB combined with Modified Pectoral Nerve Block :

SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle.

Group 2 ((Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block)

N=3o Patients will receive Ultrasound guided Serratus Anterior Plane Block with injection of 20 ml levobupivacaine 0.25%and Modified Pectoral Nerve Block with injection of 10 ml levobupivacaine 0.25%between the two pectoralis muscles, after that, the probe was turned toward the axilla, and as the serratus anterior muscle was recognized above the third and fourth ribs, 10 mL of levobupivacaine 0.25% was injected above this muscle

Group Type: ACTIVE_COMPARATOR

Serratus Anterior Plane Block

Intervention Type: PROCEDURE

SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle.

SAPB combined with Modified Pectoral Nerve Block :

SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle.

Interventions

Serratus Anterior Plane Block

SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle.

SAPB combined with Modified Pectoral Nerve Block :

SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle.

Intervention Type: PROCEDURE

Other Intervention Names

Serratus Anterior Plane Block SAPB combined with Modified Pectoral Nerve Block

Eligibility Criteria

Inclusion Criteria

• Female patients
• Type of surgery; Modified Radical Mastectomy (MRM)
• Physical status ASA I, II, III.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion Criteria

• Age <18 years or >65 years
• BMI <20 kg/m2 and >35 kg/m2
• Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
• History of psychological disorders and/or chronic pain.
• Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
• Patient refusal.
• Severe respiratory or cardiac disorders.
• Advanced liver or kidney disease.
• Pregnancy.
• Physical status ASA IV and Male patients.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Samuel Bekhet Moawad

UNKNOWN

Sponsor Role: collaborator

Ahmed Shaker Ragab

UNKNOWN

Sponsor Role: collaborator

Michael Wahib Wadid

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abdalla

Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmed Abdalla Mohamed

Cairo, , Egypt

Countries

Egypt

Other Identifiers

MS-201-2021

Identifier Type: -

Identifier Source: org_study_id