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

NCT05385523 | Completed DMC

• 1 other identifier: 97
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain, Acute

Outcome Measures

Primary Outcomes (1)

• Time of first request of analgesia.

  calculated from the time of complete injection of local anesthetics till the numerical rating scale (is more than or equals 3

  24 hours

Secondary Outcomes (4)

• Total amount of morphine consumption

  24 hours

• mean arterial blood pressure

  24 hours

• heart rate

  24 hours

• Numerical rating scale

  24 hours

Study Arms (3)

dexamedatomidine

EXPERIMENTAL

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

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

dexamethasone

EXPERIMENTAL

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

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

saline

EXPERIMENTAL

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

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

Interventions

Rhomboid Intercostal and Sub-Serratus block technique (RISS) PROCEDURE

The patient will be placed in lateral position. A linear ultrasound transducer of frequency 6-12 MHz will be placed medial to the lower border of the scapula in a sagittal plane. A 38-mm 22-gauge will be inserted under real-time in-plane from craniocaudal between the rhomboid major and intercostal muscles. After negative aspiration, single injection of 10 ml of the local anesthetic mixture will be administered at the T6 7 level. The spread of local anesthetic solution under the rhomboid muscle will be visualized by ultrasonography. Then the ultrasound probe will be moved caudally and laterally to identify the tissue plane between the serratus anterior and external intercostal muscle for the sub-serratus block at T 8-9 level. The needle will be advanced from its previous position and a further of 10 ml of the local anesthetic mixture will be injected.

dexamedatomidine; dexamethasone; saline

General Anaesthesia PROCEDURE

Fentanyl (1 μg/kg), propofol (2-3mg/kg) and atracurium (0.3-0.5 mg/kg) will be injected intravenously 3-5 minutes after oxygenation. A single-lumen endotracheal tube will be used to complete ventilation. The ventilator ventilation mode is volume control mode, and the patient's end-expiratory carbon dioxide level is maintained at 35-40 mmHg throughout the anesthesia process. During the anesthesia maintenance phase, 2% sevoflurane mixed with 60% oxygen. After general anaesthesia induction, all patients will receive RISS block with different local anesthetic drug mixture according to randomization.

dexamedatomidine; dexamethasone; saline

dexamedatomidine DRUG

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

dexamedatomidine

dexamethasone DRUG

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

dexamethasone

saline DRUG

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

saline

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Armed Forces College of Medicine, Cairo, Egypt: lead

Study Sites (1)

AFCM Egypt

Cairo, Cairo Governorate, Egypt

Location

Related Publications (3)

• Elsharkawy H, Ince I, Pawa A. Rhomboid intercostal and sub-serratus (RISS) plane block for analgesia after lung transplant. J Clin Anesth. 2019 Sep;56:85-87. doi: 10.1016/j.jclinane.2019.01.042. Epub 2019 Jan 28. No abstract available.

  PMID: 30703673 BACKGROUND

• Kaur H, Singh G, Rani S, Gupta KK, Kumar M, Rajpal AS, Aggarwal S. Effect of dexmedetomidine as an adjuvant to levobupivacaine in supraclavicular brachial plexus block: A randomized double-blind prospective study. J Anaesthesiol Clin Pharmacol. 2015 Jul-Sep;31(3):333-8. doi: 10.4103/0970-9185.161668.

  PMID: 26330711 BACKGROUND

• Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538.

  PMID: 28033159 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, General; Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Bassant Abdelhamid, MD

  AFCM Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: July 20, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 15, 2023
• Last Updated: October 2, 2025

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)