Effect of Preoperative Duloxetine on Quality of Recovery After Outpatient Laparoscopic Surgery
NCT ID: NCT02351440
Last Updated: 2018-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2016-04-30
2017-08-31
Brief Summary
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Detailed Description
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In addition, pain after ambulatory surgery remains an unsolved problem in The United States and Europe.5,6 It is associated with delayed hospital discharge and it can result to an increased opioid consumption with adverse side effects. The concept of multimodal analgesic technique was introduced more than 15 years ago and several techniques have been studied over the years including NSAIDs, acetaminophen, membrane stabilizers, ketamine, and local and regional anesthetic techniques.7,8 Both serotonin and norepinephrine have involvement in modulation of pain mechanisms in the central nervous system. Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor that has been used for mitigation of pain in such conditions as chronic musculoskeletal pain, diabetic peripheral neuropathic pain, post-herpetic neuralgia, and fibromyalgia.9,10 Duloxetine was also found to reduce postoperative morphine requirements in patients undergoing knee replacement surgery.11 The MQOR 40 is a validated instrument that was specifically design to evaluate patient recovery after anesthesia and surgery.12 This instrument can be particularly valid to examine interventions which affect different spheres of patient recovery as is the case of duloxetine.
A suicidal behavior questionnaire (SBQ-R) will be used to screen for suicidal risk among potential subjects. If any subject exhibits suicidal ideation as a result of scoring high on the questionnaire, there surgeon and/or primary care provider will be notified by the principal investigator.
The objective of this study is to determine the effect of preoperative duloxetine on postoperative quality of recovery after ambulatory surgery.
Significance: Use of preoperative duloxetine may improve patient's quality of recovery, decrease postoperative pain, opioid consumption and opioid related side effects after ambulatory surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Duloxetine
duloxetine 60mg PO
duloxetine
patients will be randomized to receive either duloxetine or placebo
Placebo
placebo
placebo
placebo
Interventions
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duloxetine
patients will be randomized to receive either duloxetine or placebo
placebo
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ASA PS 1 and 2
* fluent in English
Exclusion Criteria
18 Years
65 Years
FEMALE
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Meghan Rodes
Assistant Professor, Department of Anesthesiology
Locations
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Prentice Womens Hospital
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00096889
Identifier Type: -
Identifier Source: org_study_id
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