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Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery

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ClinicalTrials.gov Identifier: NCT02535000
Recruitment Status : Unknown
Verified April 2016 by antonio bedin, Serviço de Anestesiologia de Joinville.
Recruitment status was:  Active, not recruiting
First Posted : August 28, 2015
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
antonio bedin, Serviço de Anestesiologia de Joinville

Brief Summary:
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.

Condition or disease Intervention/treatment Phase
Intervertebral Disc Degeneration Drug: Duloxetine Drug: Placebo Phase 4

Detailed Description:
Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Study Start Date : January 2014
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group C (control)
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Drug: Placebo
placebo
Other Name: inactive substance

Active Comparator: Group D (duloxetine)
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Drug: Duloxetine
duloxetine 60 mg
Other Name: Cymbalta




Primary Outcome Measures :
  1. Fentanyl consumption. [ Time Frame: 2 days. ]
    Fentanyl (µg) consumption administered by the patient (patient-controlled analgesia) 24 and 48 hours after surgery.


Secondary Outcome Measures :
  1. Pain intensity. [ Time Frame: 2 days. ]
    Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study

Exclusion Criteria:

  • Patients allergics to duloxetine, or cetoralac to fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.

Publications:
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Responsible Party: antonio bedin, MD, Serviço de Anestesiologia de Joinville
ClinicalTrials.gov Identifier: NCT02535000     History of Changes
Other Study ID Numbers: 1
First Posted: August 28, 2015    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Duloxetine Hydrochloride
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents