NCT05442268

Brief Summary

The aim of this study is to evaluate the role of duloxetine in controlling pain after radical mastectomy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 28, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2022

Completed
15 days until next milestone

Study Start

First participant enrolled

July 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

June 28, 2022

Last Update Submit

July 16, 2022

Conditions

Modified Radical MastectomyPostoperative Analgesia

Outcome Measures

Primary Outcomes (1)

  • Total morphine consumption

    Postoperative Total morphine consumption will be recorded

    48 hours postoperatively

Secondary Outcomes (5)

  • First analgesic request

    24 hours postoperatively

  • Post-operative pain

    48 hours postoperatively.

  • Heart rate

    48 hours postoperatively

  • Mean arterial blood pressure

    48 hours postoperatively

  • Adverse effects

    48 hours postoperatively

Study Arms (2)

Acetaminophen group

EXPERIMENTAL

patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively.

Procedure: Acetaminophen group

Duloxetine group

EXPERIMENTAL

Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen (every 6 hours postoperatively)

Procedure: Duloxetine group

Interventions

Acetaminophen groupPROCEDURE

patients will receive intravenous 500 mg acetaminophen(every 6 hours postoperatively

Acetaminophen group
Duloxetine groupPROCEDURE

Patients will receive duloxetine 30 mg every 12 hours for 3 days before surgery, 30 mg 2 hours preoperatively and 30 mg 12 hours postoperatively and intravenous 500 mg acetaminophen every 6 hours postoperatively

Duloxetine group

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult female patients aged (18 - 60) years undergoing modified radical mastectomy. American Society of Anesthesiologists Classification I-II-III

You may not qualify if:

  • Known Allergies to duloxetine.
  • Abnormal liver or renal function tests.
  • Narrow angle glaucoma.
  • Being a chronic opioid abuser (more than 3 months)
  • Being on chronic gabapentin or pregabalin (more than 3 months)
  • Being on Monoamine oxidase inhibitor, tricyclic antidepressant, or fluvoxamine.
  • Pregnant female
  • Patients with psychiatric disorders or seizure disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University hospitals

Tanta, Elgarbia, Egypt

RECRUITING

Central Study Contacts

Dina Elfeky, M.B.B.CH.

CONTACT

0 111 747 2680dena154452@med.tanta.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

June 28, 2022

First Posted

July 1, 2022

Study Start

July 16, 2022

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

July 20, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will share

Data will be available under a reasonable request from the corresponding author

Shared Documents
STUDY PROTOCOL
Time Frame
one year after the end of the study

Locations

EG(1)