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Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery (Duloxetine)

Primary Purpose

Intervertebral Disc Degeneration

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Duloxetine
Placebo
Sponsored by
Serviço de Anestesiologia de Joinville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Intervertebral Disc Degeneration

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group C (control)

    Group D (duloxetine)

    Arm Description

    subjects who will receive one capsule of placebo before the surgery and being repeated the next day

    subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day

    Outcomes

    Primary Outcome Measures

    Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
    The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.

    Secondary Outcome Measures

    Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
    At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score.

    Full Information

    First Posted
    August 23, 2015
    Last Updated
    September 13, 2020
    Sponsor
    Serviço de Anestesiologia de Joinville
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02535000
    Brief Title
    Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
    Acronym
    Duloxetine
    Official Title
    Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2014 (Actual)
    Primary Completion Date
    October 20, 2015 (Actual)
    Study Completion Date
    October 30, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Serviço de Anestesiologia de Joinville

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intervertebral Disc Degeneration

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group C (control)
    Arm Type
    Experimental
    Arm Description
    subjects who will receive one capsule of placebo before the surgery and being repeated the next day
    Arm Title
    Group D (duloxetine)
    Arm Type
    Active Comparator
    Arm Description
    subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine
    Other Intervention Name(s)
    Cymbalta
    Intervention Description
    duloxetine 60 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    inactive substance
    Intervention Description
    placebo
    Primary Outcome Measure Information:
    Title
    Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
    Description
    The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.
    Time Frame
    up to 2 days.
    Secondary Outcome Measure Information:
    Title
    Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
    Description
    At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score.
    Time Frame
    up to 2 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28002096
    Citation
    Bedin A, Caldart Bedin RA, Vieira JE, Ashmawi HA. Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study. Clin J Pain. 2017 Oct;33(10):865-869. doi: 10.1097/AJP.0000000000000471.
    Results Reference
    result

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    Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery

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