NCT03468348

Brief Summary

The objective of this study is to evaluate the analgesic effect of oral dulexitine tablet (administered 2 h before surgery) as well as the ideal dose for acute postmastectomy pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 16, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

June 24, 2020

Status Verified

June 1, 2020

Enrollment Period

1.9 years

First QC Date

March 11, 2018

Last Update Submit

June 22, 2020

Conditions

Acute Pain

Keywords

duloxetinemastectomypostoperative pain

Outcome Measures

Primary Outcomes (1)

  • the first postoperative 24 h (patient controlled analgesia [PCA])morphine consumption

    the cumulative patient controlled analgesia morphine consumption required by the patients to relieve their pain in the first postoperative 24 h

    the first postoperative 24 hour

Secondary Outcomes (4)

  • The intensity of pain measured by visual analogue pain scale (VAS)

    The outcome will be assessed at 0 hour, 2 hour, 4 hour,8 hour, 16 hour and 24 hour postoperatively.

  • The quality of postoperative recovery, assessed by "The QoR-40 questionnaire" (the quality of recovery-40 questionnaire)

    the questionnair will be assessed once, 24 hour postoperatively

  • The level of consciousness assessed by "the Modified Ramsay Sedation score"

    the score will be measured at 8 hour, 16 hour and 24 hour postoperatively

  • The occurrence of vomiting

    The outcome will be obtained once 24 hour postoperatively

Study Arms (4)

placebo group

PLACEBO COMPARATOR
Drug: Duloxetine

duloxetine 30

ACTIVE COMPARATOR
Drug: Duloxetine

duloxetine 60

ACTIVE COMPARATOR
Drug: Duloxetine

duloxetine 90

ACTIVE COMPARATOR
Drug: Duloxetine

Interventions

DuloxetineDRUG

patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.

duloxetine 30duloxetine 60duloxetine 90placebo group

Eligibility Criteria

Age20 Years - 70 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult females scheduled for unilateral MRM with axillary evacuation for breast cancer,
  • American Society of Anesthesiologists physical status (ASA) class I and II

You may not qualify if:

  • Patients with a known allergy to Duloxetine or morphine,
  • A history of drug or alcohol abuse,
  • Patients with impaired kidney or liver functions,
  • Patients with chronic pain or regularly receiving analgesics,
  • Any psychiatric illness that would interfere with the perception and the assessment of pain.
  • Any reason that resulted in the protocol violation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diab

Asyut, Assuit, 71515, Egypt

Location

Related Publications (1)

  • Hetta DF, Elgalaly NA, Hetta HF, Fattah Mohammad MA. Preoperative Duloxetine to improve acute pain and quality of recovery in patients undergoing modified radical mastectomy: A dose-ranging randomized controlled trial. J Clin Anesth. 2020 Dec;67:110007. doi: 10.1016/j.jclinane.2020.110007. Epub 2020 Aug 22.

    PMID: 32847776DERIVED

MeSH Terms

Conditions

Acute PainPain, Postoperative

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

March 11, 2018

First Posted

March 16, 2018

Study Start

April 1, 2018

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

June 24, 2020

Record last verified: 2020-06

Locations

EG(1)