NCT05361837

Brief Summary

This study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

April 27, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
5 days until next milestone

Study Start

First participant enrolled

May 10, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

April 27, 2022

Last Update Submit

May 12, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (2)

  • First time to receive analgesia

    first time to receive morphine analgesia in hours

    First 24 hours postoperatively

  • Total analgesic requisite

    total amount of morphine consumption in the first 24 hours postoperatively in mg

    First 24 hours postoperatively

Secondary Outcomes (4)

  • Pain scores

    First 24 hours postoperatively

  • Side effects

    First 24 hours postoperatively

  • Perioperative heart rate values

    First 24 hours

  • Mean arterial blood pressure

    First 24 hours

Study Arms (4)

Single level serratus anterior plane block

ACTIVE COMPARATOR

the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics only

Procedure: Single level serratus anterior plane block

Single level serratus anterior plane block with dexmedetomidine

EXPERIMENTAL

the allocated patients will receive single injection serratus anterior plane block at the level of third rib with local anesthetics and dexmedetomidine

Procedure: Single level serratus anterior plane block with dexmedetomidine

Bilevel serratus anterior plane block

EXPERIMENTAL

the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics only

Procedure: Bilevel serratus anterior plane block

Bilevel serratus anterior plane block with dexmedetomidine

EXPERIMENTAL

the allocated patients will receive injection serratus anterior plane block at 2 levels, the level of third rib and the level of the fifth rib with local anesthetics and dexmedetomidine

Procedure: Bilevel serratus anterior plane block with dexmedetomidine

Interventions

Single level serratus anterior plane blockPROCEDURE

Serratus anterior plane block with local anesthetics at the third rib

Single level serratus anterior plane block
Single level serratus anterior plane block with dexmedetomidinePROCEDURE

Serratus anterior plane block with local anesthetics and dexmedetomidine at the third rib

Single level serratus anterior plane block with dexmedetomidine
Bilevel serratus anterior plane blockPROCEDURE

Serratus anterior plane block with local anesthetics at the third and fifth rib

Bilevel serratus anterior plane block
Bilevel serratus anterior plane block with dexmedetomidinePROCEDURE

Serratus anterior plane block with local anesthetics and dexmedetomidine at the third and fifth rib

Bilevel serratus anterior plane block with dexmedetomidine

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:

  • patients scheduled for modified radical mastectomy,
  • Age 18-65 years,
  • ASA I-II

You may not qualify if:

  • patient refusal,
  • coagulation defects,
  • abnormal kidney or liver functions,
  • local infection at site of injection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Walaa Y Elsabeeny, MD

    Assistant Professor of Anesthesia and Pain management

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Walaa Y Elsabeeny, MD

CONTACT

201007798466walaa.elsabeeny@nci.cu.edu.eg

Nahla N Shehab, MD

CONTACT

01221682808nahla.shehab2@gmail.com

Study Design

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

Study Record Dates

First Submitted

April 27, 2022

First Posted

May 5, 2022

Study Start

May 10, 2022

Primary Completion

August 15, 2024

Study Completion

August 25, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations

EG(1)