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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

Tracking Information
First Submitted Date  ICMJE August 23, 2015
First Posted Date  ICMJE August 28, 2015
Last Update Posted Date April 14, 2016
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
Fentanyl consumption. [ Time Frame: 2 days. ]
Fentanyl (µg) consumption administered by the patient (patient-controlled analgesia) 24 and 48 hours after surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02535000 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2015)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Official Title  ICMJE Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Intervertebral Disc Degeneration
Intervention  ICMJE
  • Drug: Duloxetine
    duloxetine 60 mg
    Other Name: Cymbalta
  • Drug: Placebo
    placebo
    Other Name: inactive substance
Study Arms  ICMJE
  • Experimental: Group C (control)
    subjects who will receive one capsule of placebo before the surgery and being repeated the next day
    Intervention: Drug: Placebo
  • Active Comparator: Group D (duloxetine)
    subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
    Intervention: Drug: Duloxetine
Publications * Coura LE, Manoel CH, Poffo R, Bedin A, Westphal GA. Randomised, controlled study of preoperative electroacupuncture for postoperative pain control after cardiac surgery. Acupunct Med. 2011 Mar;29(1):16-20. doi: 10.1136/aim.2010.003251.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 25, 2015)
60
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2016
Estimated Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02535000
Other Study ID Numbers  ICMJE 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party antonio bedin, Serviço de Anestesiologia de Joinville
Study Sponsor  ICMJE Serviço de Anestesiologia de Joinville
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Serviço de Anestesiologia de Joinville
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP