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

N

National Cancer Institute, Egypt

Status

Completed

Conditions

Analgesia

Treatments

Drug: Intravenous morphine
Procedure: Bilateral Erector spinae plane block with dexamethasone
Procedure: Bilateral Erector spinae plane block with dexmedetomidine
Procedure: Bilevel Erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT05591417
AP2207-30110

Details and patient eligibility

About

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.

Full description

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.

Enrollment

68 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

68 participants in 4 patient groups

Intravenous morphine
Active Comparator group
Description:
Patients will receive intravenous morphine 0.1 mg/kg
Treatment:
Drug: Intravenous morphine
Bilevel erector spinae plane block
Experimental group
Description:
Patients will receive erector spinae plane block at 2 levels
Treatment:
Procedure: Bilevel Erector spinae plane block
Bilevel erector spinae plane block with dexamethasone
Experimental group
Description:
Patients will receive erector spinae plane block at 2 levels with dexamethasone
Treatment:
Procedure: Bilateral Erector spinae plane block with dexamethasone
Bilevel erector spinae plane block with dexmedetomidine
Experimental group
Description:
Patients will receive erector spinae plane block at 2 levels with dexmedetomidine
Treatment:
Procedure: Bilateral Erector spinae plane block with dexmedetomidine

Trial contacts and locations

1

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Central trial contact

Walaa Y Elsabeeny, MD; Reham M Fahmy, M.Sc

Data sourced from clinicaltrials.gov

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