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

NCT05156775 | Unknown

• 1 other identifier: 34981/10/21
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Mastectomy; Rhomboid Intercostal Block; Serratus Plane Block

Outcome Measures

Primary Outcomes (1)

• The total rescue morphine (mg) consumption in the first 24 post-operative hours.

  Rescue analgesia in the form of 3 mg intravenous morphine (mg) will be given if the visual analog scale is ≥ 4 repeated with 10 minutes lockout interval till the visual analog scale becomes less than 3 guided with the occurrence of complications as nausea, vomiting, and respiratory depression.

  24 hours postoperative

Secondary Outcomes (6)

• Post-operative pain assessed by visual analog scale (VAS)

  24 hours Postoperative

• Heart rate

  Intraoperative

• Mean arterial blood pressure

  Intraoperative

• Time to first rescue analgesic request (minutes)

  24 hours Postoperative

• Intraoperative fentanyl consumption (µg).

  Intraoperative

Study Arms (3)

Intravenous analgesia group

NO INTERVENTION

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

Serratus Plane Block (SPB) group

EXPERIMENTAL

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

Other: Serratus Plane Block (SPB)

Rhomboid intercostal nerve block (RIB) group

EXPERIMENTAL

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

Other: Rhomboid intercostal nerve block (RIB)

Interventions

Serratus Plane Block (SPB) 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.

Serratus Plane Block (SPB) group

Rhomboid intercostal nerve block (RIB) 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.

Rhomboid intercostal nerve block (RIB) group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospital

Tanta, Elgharbia, 31511, Egypt

RECRUITING

Central Study Contacts

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

CONTACT

1143441294; dina154456@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesia, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: November 27, 2021
• First Posted: December 14, 2021
• Study Start: January 1, 2022
• Primary Completion: May 29, 2022
• Study Completion: May 29, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: One year after the end of the study

Locations

EG (1)