NCT02351440

Brief Summary

The objective of this study is to determine the effect of preoperative duloxetine on postoperative quality of recovery after ambulatory surgery, specifically laparoscopic gynecological surgery.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

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

January 27, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

August 21, 2018

Status Verified

August 1, 2018

Enrollment Period

1.4 years

First QC Date

January 27, 2015

Last Update Submit

August 20, 2018

Conditions

Quality of RecoveryGynecologic SurgeryLaparoscopy

Keywords

duloxetine

Outcome Measures

Primary Outcomes (1)

  • QOR-40 global score

    24 hours

Secondary Outcomes (1)

  • intraoperative opioid consumption

    1 hour

Study Arms (2)

Duloxetine

EXPERIMENTAL

duloxetine 60mg PO

Drug: duloxetine

Placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

duloxetineDRUG

patients will be randomized to receive either duloxetine or placebo

Also known as: Cymbalta
Duloxetine
placeboDRUG

placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • outpatient gynecological laparoscopy
  • ASA PS 1 and 2
  • fluent in English

You may not qualify if:

  • history of allergy to duloxetine, history of chronic opioid use, pregnant patients, preoperative SSRI or SNRI use, prolonged QT interval on ECG

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prentice Womens Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Anesthesiology

Study Record Dates

First Submitted

January 27, 2015

First Posted

January 30, 2015

Study Start

April 1, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

August 21, 2018

Record last verified: 2018-08

Locations

US(1)