NCT06300099

Brief Summary

Modified radical mastectomy is the most commonly performed surgical approach for breast cancer. The procedure enables surgeons to remove the main tumor mass, adjacent glandular tissue and regional lymph nodes. Moreover, it provides a cosmetic outcome that clearly surpasses the standard radical mastectomy and allows subsequent breast reconstruction with favorable results. The present randomized study aims to compare the postoperative analgesic effects of dexamethasone and dexmedetomidine as adjuncts to serratus anterior plane block in women undergoing modified radical mastectomy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for phase_4 breast-cancer

Timeline
Completed

Started Apr 2024

Shorter than P25 for phase_4 breast-cancer

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 2, 2024

Last Update Submit

March 8, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • postoperative visual assessment scale for pain.

    Subjective pain assessment scale

    72 hours postoperative

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone injection

Drug: Dexamethasone

Dexmedetomidine

ACTIVE COMPARATOR

Dexmedetomidine injection.

Drug: Dexmedetomidine

Interventions

DexamethasoneDRUG

Dexamethasone as adjunct to serratus anterior plane block.

Dexamethasone
DexmedetomidineDRUG

Dexmedetomidine as adjunct to serratus anterior plane block.

Dexmedetomidine

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Consecutive American Society of Anesthesiologists (ASA) class I-II female patients with breast cancer indicated for modified radical mastectomy

You may not qualify if:

  • Allergy to the study medications . Patients will also be excluded if they have history of chronic pain conditions, opioid dependence or if they received prolonged analgesic therapy prior to surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DexamethasoneDexmedetomidine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 2, 2024

First Posted

March 8, 2024

Study Start

April 1, 2024

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share