Dexamedatomidine vs. Dexamethasone in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery

Armed Forces College of Medicine, Cairo, Egypt

Status: Unknown

Conditions: Postoperative Pain, Acute

Treatments: Drug: dexamedatomidine; Drug: dexamethasone; Procedure: General Anaesthesia; Procedure: Rhomboid Intercostal and Sub-Serratus block technique (RISS); Drug: saline

Study type: Interventional

Funder types: Other

Identifiers

NCT05385523

97

Details and patient eligibility

About

The aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine and dexamethasone to bupivacaine in rhomboidal intercostal and subserratus (RISS) block for patients undergoing modified radical mastectomy compared to bupivacaine only.

Full description

Rhomboid intercostal block (RIB); a new interfascial plane block involves the triangle of auscultation that's bounded medially by inferior a part of the trapezius, inferiorly by the superior border of latissimus dorsi, and laterally by the medial border of the scapula. The local anaesthetic spreads between the rhomboid major and therefore the intercostal fascia at the extent of T6-T7 and provides analgesia of T3-T8 dermatomes.

Aiming to expand dermatomal coverage, a new modification of Rhomboid Intercostal and Sub-Serratus block (RISS) is performed by advancing the ultrasound probe caudally and laterally distal to the inferior angle of the scapula, the second injection apply between the serratus and intercostal muscle fascia. The RISS block is a novel ultrasound-guided block that has been shown to provide analgesia from T2-T11 dermatomes.

Dexmedetomidine is a potent selective α 2 adrenoceptor agonist that was reported in many previous studies as an adjunct to regional and general anesthesia, with significant prolongation of the duration of sensory block, motor block and analgesia, and accelerate the time to onset of sensory and motor block when added to a local anesthetic.

Dexamethasone is a potent long-acting steroid that has shown efficacy as an adjuvant to local anesthetics in various studies. It enhances peripheral nerve blocks when added to local anesthetics, providing better quality of anesthesia as well as postoperative analgesia. The mechanism by which dexamethasone prolong the duration of local anesthetics are not completely understood; however, some studies demonstrated that dexamethasone exerts its action through reducing the release of inflammatory mediators and by inhibiting discharge of C-fibers.

Enrollment: 70 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult female patient
• Type of surgery; Modified Radical Mastectomy (MRM).
• Physical status ASA II, III.
• Age ≥ 21 and ≤ 65 Years.
• Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2.

Exclusion criteria

• Patient refusal.
• Patients suffering from coagulation disorders.
• Patients with histories of allergic reactions to local anesthetics or dexmedetomidine.
• Patients suffering from neuropsychiatric disorders.
• Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 3 patient groups

dexamedatomidine

Experimental group

Description:

Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.

Treatment:

Procedure: General Anaesthesia

Procedure: Rhomboid Intercostal and Sub-Serratus block technique (RISS)

Drug: dexamedatomidine

dexamethasone

Experimental group

Description:

Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.

Treatment:

Procedure: General Anaesthesia

Procedure: Rhomboid Intercostal and Sub-Serratus block technique (RISS)

Drug: dexamethasone

saline

Experimental group

Description:

Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.

Treatment:

Procedure: General Anaesthesia

Drug: saline

Procedure: Rhomboid Intercostal and Sub-Serratus block technique (RISS)