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

Not Applicable

• Conditions: Mastectomy; Rhomboid Intercostal Block; Serratus Plane Block
• Interventions: Other: Serratus Plane Block (SPB); Other: Rhomboid intercostal nerve block (RIB)

• Registration Number: NCT05156775
• Lead Sponsor: Tanta University

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

Study Timeline

• Study First Submitted: 2021-11-27
• Study First Submitted QC: 2021-12-11
• Study First Posted: 2021-12-14
• Study Start: 2022-01-01
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02
• Primary Completion: 2022-05-29
• Study Completion: 2022-05-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serratus Plane Block (SPB) group	Serratus Plane Block (SPB)	35 Patients will receive ipsilateral serratus plane block using 30 ml bupivacaine 0.25% at the level of the 5th rib.
Rhomboid intercostal nerve block (RIB) group	Rhomboid intercostal nerve block (RIB)	35 Patients will receive ipsilateral rhomboid intercostal nerve block using 30 ml bupivacaine 0.25%.

Primary Outcome Measures

Name	Time	Method
The total rescue morphine (mg) consumption in the first 24 post-operative hours.	24 hours postoperative	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.

Secondary Outcome Measures

Name	Time	Method
Post-operative pain assessed by visual analog scale (VAS)	24 hours Postoperative	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)
Heart rate	Intraoperative	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
Time to first rescue analgesic request (minutes)	24 hours Postoperative	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
Mean arterial blood pressure	Intraoperative	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
Adverse effects	intraoperative or 24 hours Postoperative	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 fentanyl consumption (µg).	Intraoperative	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

Trial Locations

Locations (1)

Tanta University Hospital; 🇪🇬 Tanta, Elgharbia, Egypt