NCT05429489

Brief Summary

This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

June 27, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
Last Updated

January 23, 2024

Status Verified

January 1, 2024

Enrollment Period

1.5 years

First QC Date

June 17, 2022

Last Update Submit

January 20, 2024

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

  • Total analgesic requisite

    total postoperative morphine consumption

    First 24 hours postoperatively

Study Arms (3)

Bilevel erector spinae plane block

EXPERIMENTAL

Bilevel erector spinae block at 3rd and 5th thoracic vertebral levels

Procedure: Bilevel erector spinae plane block

Single level erector spinae plane block

EXPERIMENTAL

single level erector spinae plane block at 5th thoracic vertebral levels

Procedure: Single level erector spinae plane block

Intravenous morphine

ACTIVE COMPARATOR

Intravenous morphine 0.1 mg/ kg

Drug: Intravenous morphine

Interventions

Bilevel erector spinae plane blockPROCEDURE

Bilevel erector spinae plane block at 3rd and 5th thoracic vertebral levels

Bilevel erector spinae plane block
Single level erector spinae plane blockPROCEDURE

Single level erector spinae plane block at 5th thoracic vertebrae

Single level erector spinae plane block
Intravenous morphineDRUG

Intravenous morphine 0.1 mg/kg

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
  • Diagnosed with breast cancer

You may not qualify if:

  • Patient refusal
  • coagulation defects
  • bone metastases
  • abnormal kidney and/or liver function tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walaa Y Elsabeeny

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Study Officials

  • Walaa Y Elsabeeny, MD

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, 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

June 17, 2022

First Posted

June 23, 2022

Study Start

June 27, 2022

Primary Completion

December 27, 2023

Study Completion

January 10, 2024

Last Updated

January 23, 2024

Record last verified: 2024-01

Locations

EG(1)