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

Not Applicable

• Conditions: Postoperative Pain, Acute
• Interventions: Procedure: Rhomboid Intercostal and Sub-Serratus block technique (RISS); Procedure: General Anaesthesia; Drug: dexamedatomidine; Drug: saline; Drug: dexamethasone

• Registration Number: NCT05385523
• Lead Sponsor: Armed Forces College of Medicine, Cairo, Egypt

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2022-05
• Study First Submitted: 2022-05-18
• Study Start: 2022-05-20
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-23
• Last Update Submitted: 2022-05-25
• Last Update Posted: 2022-05-31
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dexamedatomidine	dexamedatomidine	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
dexamedatomidine	Rhomboid Intercostal and Sub-Serratus block technique (RISS)	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
dexamethasone	Rhomboid Intercostal and Sub-Serratus block technique (RISS)	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
saline	General Anaesthesia	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
dexamedatomidine	General Anaesthesia	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 1 Mcg/kg dexamedatomidine in 2 mL.
saline	Rhomboid Intercostal and Sub-Serratus block technique (RISS)	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
dexamethasone	General Anaesthesia	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.
saline	saline	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine+ 2 mL normal saline.
dexamethasone	dexamethasone	Patients will receive general anaesthesia and RISS block with 20 ml of 0.25% bupivacaine + 8mg dexamethasone in 2 mL.

Primary Outcome Measures

Name	Time	Method
Time of first request of analgesia.	24 hours	calculated from the time of complete injection of local anesthetics till the numerical rating scale (is more than or equals 3

Secondary Outcome Measures

Name	Time	Method
Total amount of morphine consumption	24 hours
mean arterial blood pressure	24 hours
heart rate	24 hours
Numerical rating scale	24 hours	The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").