The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Mastectomy.

NCT ID: NCT05156775

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-05-29

Brief Summary

The aim of this study is to evaluate analgesic efficacy of ultrasound-guided rhomboid plane block or serratus plane block versus Intravenous opioid in patients undergoing modified radical mastectomy.

Detailed Description

Breast cancer is the most frequently diagnosed malignancy and is the leading cause of cancer-related death among the female population.

Modified radical mastectomy (MRM) is the standard surgical treatment for cancer breast, which is usually associated with moderate to severe acute postoperative pain. Adequate postoperative pain relief is important to improve functional outcomes and to accelerate recovery and decrease hospital stay.

The postoperative pain may last >3 to 6 months after surgery and may proceed to chronic pain, with an incidence of 20% to 30%. Because chronic pain has many negative effects on patients, it may decrease the overall quality of life and may be a potential source of chronic opioid use. Therefore, preventing chronic pain is essential in these patients. In this regard, good acute postoperative pain management strategies have a very important role.

Regional anesthesia techniques can provide good postoperative pain management and may cause less incidence of chronic pain.

Many analgesic techniques have been proposed to relieve acute postoperative pain, including intercostal block, local anesthetic (LA) infiltration, block, paravertebral block, serratus plane block (SPB), and rhomboid intercostal block (RIB) to relieve acute postoperative pain

Conditions

Mastectomy; Rhomboid Intercostal Block; Serratus Plane Block

Study Design

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

Study Groups

Intravenous analgesia group

35 Patients will receive intravenous morphine (mg) analgesia only.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Serratus Plane Block (SPB) group

35 Patients will receive ipsilateral serratus plane block using 30 ml bupivacaine 0.25% at the level of the 5th rib.

Group Type: EXPERIMENTAL

Serratus Plane Block (SPB)

Intervention Type: OTHER

While the patient is in the supine position, the arm will be abducted, the ultrasound probe will be placed over the mid-clavicular region of the thoracic cage in sagittal plane. Ribs will be counted until the fifth rib will be identified in the midaxillary line. the latissimus dorsi (superficial and posterior ), teres major (superior), and serratus muscle (deep and inferior)will be identified overlying the fifth rib. As an extra reference point, thoracodorsal artery will be used, this aids in the identification of the plane superficial to the serratus muscle, 30 ml 0.25 %bupivacaine will be injected between latissimus dorsi and serratus anterior muscles at the level of the 5th rib in the mid axillary line.

Rhomboid intercostal nerve block (RIB) group

35 Patients will receive ipsilateral rhomboid intercostal nerve block using 30 ml bupivacaine 0.25%.

Group Type: EXPERIMENTAL

Rhomboid intercostal nerve block (RIB)

Intervention Type: OTHER

In the rhomboid intercostal nerve block (RIB) group, the patient will be placed in a lateral position with the affected breast at the top. The ipsilateral arm will be extended to the same level as the ipsilateral chest and breast, and the scapula will be moved outward. On the oblique sagittal plane, a high frequency (6-12MHz) linear ultrasound probe will be placed on the medial edge of the scapula. The US landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. Under the aseptic condition, a 22-gauge needle will be inserted in the plan to the US probe at T5 to T6 levels. Then, 0.25% bupivacaine (30 mL) will be injected into the inter-fascial plane between the rhomboid major muscle and the intercostal muscle, the diffusion of bupivacaine in the fascia between the rhomboid muscle and the intercostal muscle will be visualized. Then, the patient will be positioned in supine position.

Interventions

Serratus Plane Block (SPB)

While the patient is in the supine position, the arm will be abducted, the ultrasound probe will be placed over the mid-clavicular region of the thoracic cage in sagittal plane. Ribs will be counted until the fifth rib will be identified in the midaxillary line. the latissimus dorsi (superficial and posterior ), teres major (superior), and serratus muscle (deep and inferior)will be identified overlying the fifth rib. As an extra reference point, thoracodorsal artery will be used, this aids in the identification of the plane superficial to the serratus muscle, 30 ml 0.25 %bupivacaine will be injected between latissimus dorsi and serratus anterior muscles at the level of the 5th rib in the mid axillary line.

Intervention Type: OTHER

Rhomboid intercostal nerve block (RIB)

In the rhomboid intercostal nerve block (RIB) group, the patient will be placed in a lateral position with the affected breast at the top. The ipsilateral arm will be extended to the same level as the ipsilateral chest and breast, and the scapula will be moved outward. On the oblique sagittal plane, a high frequency (6-12MHz) linear ultrasound probe will be placed on the medial edge of the scapula. The US landmarks, trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung will be identified. Under the aseptic condition, a 22-gauge needle will be inserted in the plan to the US probe at T5 to T6 levels. Then, 0.25% bupivacaine (30 mL) will be injected into the inter-fascial plane between the rhomboid major muscle and the intercostal muscle, the diffusion of bupivacaine in the fascia between the rhomboid muscle and the intercostal muscle will be visualized. Then, the patient will be positioned in supine position.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Female patients
• Scheduled for unilateral modified radical mastectomy.
• Age 18-65 years
• American Society of Anesthesiologists (ASA) physical status I- II

Exclusion Criteria

• Patient refusal
• Coagulation disorders
• Body mass index > 35 kg/m2
• Uncooperative or psychiatric patients
• Infection at the injection site
• Patients with a history of allergy to local anesthetics
• Patients with a history of treatment for chronic pain
• Previous history of breast surgery or other chest surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Dina Hamdy Alhassanin

Resident of Anesthesia, Surgical Intensive Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University Hospital

Tanta, Elgharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina H. Alhassanin, M.B.B.CH

Role: CONTACT

dina154456@med.tanta.edu.eg

1143441294 ext. +20

Facility Contacts

Dina H Alhassanin

Role: primary

dina154456@med.tanta.edu.eg

00201143441294

Other Identifiers

34981/10/21

Identifier Type: -

Identifier Source: org_study_id