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Clinical Trials/NCT05385523
NCT05385523
Completed
Not Applicable

Comparison Between Analgesic Effect of Adding Dexamedatomidine or Dexamethasone to Bupvicaine in Rhomboidal Intercostal Plain Block and Subserratus Block in Breast Surgery

Armed Forces College of Medicine, Cairo, Egypt1 site in 1 country70 target enrollmentJuly 20, 2022

Overview

Phase
Not Applicable
Intervention
Rhomboid Intercostal and Sub-Serratus block technique (RISS)
Conditions
Postoperative Pain, Acute
Sponsor
Armed Forces College of Medicine, Cairo, Egypt
Enrollment
70
Locations
1
Primary Endpoint
Time of first request of analgesia.
Status
Completed
Last Updated
7 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2022
End Date
June 15, 2023
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Armed Forces College of Medicine, Cairo, Egypt
Responsible Party
Principal Investigator
Principal Investigator

bassant mohamed

Professor

Armed Forces College of Medicine, Cairo, Egypt

Eligibility Criteria

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.

Arms & Interventions

dexamedatomidine

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

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

dexamedatomidine

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

Intervention: General Anaesthesia

dexamedatomidine

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

Intervention: dexamedatomidine

dexamethasone

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

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

dexamethasone

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

Intervention: General Anaesthesia

dexamethasone

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

Intervention: dexamethasone

saline

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

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

saline

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

Intervention: General Anaesthesia

saline

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

Intervention: saline

Outcomes

Primary Outcomes

Time of first request of analgesia.

Time Frame: 24 hours

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

Secondary Outcomes

  • heart rate(24 hours)
  • Total amount of morphine consumption(24 hours)
  • mean arterial blood pressure(24 hours)
  • Numerical rating scale(24 hours)

Study Sites (1)

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