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

Mastectomy Clinical Trial

Official title:

The Efficacy of Ultrasound-Guided Rhomboid Intercostal Block Versus Serratus Plane Block in Patients Undergoing Modified Radical Mastectomy: A Prospective Randomized Controlled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05156775
• Other study ID #: 34981/10/21
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: May 29, 2022

Study information

• Verified date: February 2022
• Source: Tanta University
• Contact: Dina H. Alhassanin, M.B.B.CH
• Phone: 1143441294
• Email: dina154456[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: May 29, 2022
• Est. primary completion date: May 29, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mastectomy
• Serratus Plane Block

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Egypt	Tanta University Hospital	Tanta	Elgharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post-operative pain assessed by visual analog scale (VAS)	Postoperative pain will be assessed using a visual analog scale after 15 minutes after admission to the Post-anesthesia care unit and, 2, 4, 6, 8, 12,16, and 24 hours postoperatively.; VAS ranged from 0 to 10 (the lowest is less pain)	24 hours Postoperative
Secondary	Heart rate	Heart rate (beats/min) will be recorded at baseline before induction, after induction, and before skin incision then every 15 minutes till the end of the operation	Intraoperative
Secondary	Mean arterial blood pressure	Mean arterial blood pressure will be recorded at baseline before induction, after induction, and before skin incision then every 15 minutes till the end of the operation	Intraoperative
Secondary	Time to first rescue analgesic request (minutes)	Time to the first rescue analgesic request (minutes) will be also recorded. Rescue analgesia in the form of 3 mg intravenous morphine (mg) will be given if the visual analog scale is = 4	24 hours Postoperative
Secondary	Intraoperative fentanyl consumption (µg).	Inadequate analgesia in the form of increase of heart rate or mean arterial blood pressure = 20% above the baseline will be managed using 1µg/ kg of IV fentanyl. The total intravenous fentanyl consumption will be recorded at the end of the operation	Intraoperative
Secondary	Adverse effects	Any intraoperative or postoperative complications such as nausea, vomiting, hematoma, hypotension (defined as any decrease in mean arterial blood pressure of >20% of the preoperative baseline value), Bradycardia (defined as a decrease in heart rate < 50 beat/min), or pneumothorax will be recorded. Bradycardia will be treated by atropine intravenous injection (0.01 mg/kg) which may be repeated if needed. Hypotension will be treated by250 ml intravenous saline, and a bolus dose of intravenous Ephedrine 5 mg, which may be repeated if no response.	intraoperative or 24 hours Postoperative