NCT05591417

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
3 days until next milestone

Study Start

First participant enrolled

October 27, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.9 years

First QC Date

October 19, 2022

Last Update Submit

October 25, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption in the first 24 hours postoperatively.

    Assessment of total postoperative morphine consumption

    First 24 hours postoperatively

Study Arms (4)

Intravenous morphine

ACTIVE COMPARATOR

Patients will receive intravenous morphine 0.1 mg/kg

Drug: Intravenous morphine

Bilevel erector spinae plane block

EXPERIMENTAL

Patients will receive erector spinae plane block at 2 levels

Procedure: Bilevel Erector spinae plane block

Bilevel erector spinae plane block with dexamethasone

EXPERIMENTAL

Patients will receive erector spinae plane block at 2 levels with dexamethasone

Procedure: Bilateral Erector spinae plane block with dexamethasone

Bilevel erector spinae plane block with dexmedetomidine

EXPERIMENTAL

Patients will receive erector spinae plane block at 2 levels with dexmedetomidine

Procedure: Bilateral Erector spinae plane block with dexmedetomidine

Interventions

Bilevel Erector spinae plane blockPROCEDURE

Patients will receive bilevel erector spinae plane block with bupivacaine

Also known as: BileveL ESPB
Bilevel erector spinae plane block
Bilateral Erector spinae plane block with dexamethasonePROCEDURE

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

Also known as: Bilevel ESPB with dexamethasone
Bilevel erector spinae plane block with dexamethasone
Bilateral Erector spinae plane block with dexmedetomidinePROCEDURE

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

Also known as: Bilevel ESPB with dexmedetomidine
Bilevel erector spinae plane block with dexmedetomidine
Intravenous morphineDRUG

Intravenous morphine 0.1 mg/kg

Also known as: Morphine
Intravenous morphine

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

DexamethasoneDexmedetomidineMorphine

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic Hydrocarbons

Study Officials

  • Walaa Y Elsabeeny, MD

    Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Anesthesia and Pain management

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

October 27, 2022

Primary Completion

September 25, 2024

Study Completion

September 30, 2024

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

EG(1)