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Completed

NCT Number: NCT05591417

Dexmedetomidine vs Dexamethasone as Adjuvant to Bupivacaine in Bilevel Erector Spinae Plane Block in Breast Surgeries

High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Walaa Y Elsabeeny

Cairo, 11796, Egypt

About this study

High percent of patients experience chronic pain following breast cancer surgeries thus proper perioperative pain control is crucial to lessen the incidence of such pain. Several techniques are adopted to control perioperative pain, these techniques include drugs as opioids and adjuvants as well as regional blocks. Erector spinae plane block is a regional technique that is used efficiently to control perioperative pain during and following breast cancer surgeries. Adding adjuvant drugs as dexmedetomidine or dexamethasone can augment the local anesthetic effect for the regional block used.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female patients scheduled for Modified Radical Mastectomy MRM
  • Physical status ASA II, III.
  • Age (18-65) years
  • Body mass index (BMI): (20-35) kg/m2.

Exclusion criteria

  • Patient refusal.
  • Age <18 years or >65 years.
  • BMI <20 kg/m2 and >35 kg/m2.
  • Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids, dexamethasone, dexmedetomedine).

Treatment and study plan

Bilevel erector spinae plane block

Procedure

Patients will receive bilevel erector spinae plane block with bupivacaine

Other names: BileveL ESPB

Bilateral Erector spinae plane block with dexamethasone

Procedure

Patients will receive bilevel erector spinae plane block with bupivacaine and dexamethasone

Other names: Bilevel ESPB with dexamethasone

Bilateral Erector spinae plane block with dexmedetomidine

Procedure

Patients will receive bilevel erector spinae plane block with bupivacaine and dexmedetomidine

Other names: Bilevel ESPB with dexmedetomidine

intravenous morphine

Drug

Intravenous morphine 0.1 mg/kg

Other names: Morphine

Primary outcomes

  1. Total morphine consumption in the first 24 hours postoperatively.

    Time frame: First 24 hours postoperatively

    Assessment of total postoperative morphine consumption

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

Comparison of Dexmedetomidine and Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Bilevel Erector Spinae Plane Block in Modified Radical Mastectomy

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2022
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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