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Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Morphine
Oxycodone
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Adverse Drug Reaction, Morphine, Oxycodone, Abdominal hysterectomy

Eligibility Criteria

30 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients scheduled for abdominal hysterectomy
  • Signing for informed consent

Exclusion Criteria:

  • Patients used with MAO inhibitor drugs (<14 days before surgery)
  • History of substance abuse
  • Hypersensitivity to opioids and others drugs of multimodal analgesia (metamizol and lidocaine)
  • Pretreatment of any opioid (<7/2 lives of the drug in question)
  • Chronic pain of any etiology (> 6 months)
  • Diagnosis of bowel obstruction
  • Renal or hepatic insufficiency
  • Asthma, chronic obstructive pulmonary disease (COPD), and/ or hypothyroidism.
  • Patients requiring general anesthesia for surgical complications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Morphine

    Oxycodone

    Arm Description

    Multimodal analgesia to morphine

    Multimodal analgesia to oxycodone

    Outcomes

    Primary Outcome Measures

    Adverse drug reactions (questionnaire)
    Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis

    Secondary Outcome Measures

    Postoperative pain (Numeric Pain Rating Scale)
    systemic blood pressure (mmHg) (physiological parameter)
    Monitor Nihon Kohden BSM-2301K
    Heart rate (physiological parameter)
    Monitor Nihon Kohden BSM-2301K
    Oxygen saturation (physiological parameter)
    Monitor Nihon Kohden BSM-2301K

    Full Information

    First Posted
    October 14, 2016
    Last Updated
    October 14, 2016
    Sponsor
    Hospital Civil de Guadalajara
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02936934
    Brief Title
    Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    December 2016 (Anticipated)
    Study Completion Date
    February 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Civil de Guadalajara

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The objective of this study is compare adverse reactions associated with oxycodone and morphine for the treatment of postoperative pain after abdominal hysterectomy
    Detailed Description
    A randomized single-blind study, was performed to compare the adverse reactions associated with oxycodone and morphine in patients undergoing abdominal hysterectomy. process: A clinical history of patients candidates to participate in the study will be developed. If you meet the selection criteria will be held the invitation to participate in the study, reading the letter under information Patients who agree to participate in the study will be managet during the surgical procedure: 15 mg mixed blockade with bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg intravenously during surgery metamizol 3) After the surgical procedure (immediate postoperative) • the patient to group A or B (randomization) is assigned, masking infusions and allocation will be conducted by an outside person who will test an additional record the names of the patients and the drug administered. A bolus of oxycodone or morphine 10% calculated dose for intravenous infusion 0.075mg intravenous palonosetron prophylaxis of emesis Detection and assessment of severity of adverse drug reactions will be conducted by an interview that will be at 0,1,2,6,12 and 24 hours after the onset of analgesia. Instrument designed for the detection of RAM will be used and classify its severity according to common terminology criteria for adverse events (CTCAE). Futhermore, measuring systemic blood pressure, heart rate, oxygen saturation will be performed through the use of Nihon Kohden monitor (model BSN-2301K). Pain assessment will be made by the numerical scale (NRS). The researcher responsible for the detection and assessment of adverse reactions to opioids and others determinations, remain mowed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Postoperative
    Keywords
    Adverse Drug Reaction, Morphine, Oxycodone, Abdominal hysterectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Morphine
    Arm Type
    Active Comparator
    Arm Description
    Multimodal analgesia to morphine
    Arm Title
    Oxycodone
    Arm Type
    Experimental
    Arm Description
    Multimodal analgesia to oxycodone
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Intervention Description
    Interventions pre-specified to be administered to participants: Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery Intravenous infusion: 200μg / kg of morphine + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration:24hours
    Intervention Type
    Drug
    Intervention Name(s)
    Oxycodone
    Intervention Description
    Interventions pre-specified to be administered to participants: Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery Intravenous infusion: 150μg / kg of oxycodone + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration: 24hours.
    Primary Outcome Measure Information:
    Title
    Adverse drug reactions (questionnaire)
    Description
    Nausea, vomiting, respiratory depression, dizziness, headache, sedation, pruritus and anaphylaxis
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    Postoperative pain (Numeric Pain Rating Scale)
    Time Frame
    24 hours
    Title
    systemic blood pressure (mmHg) (physiological parameter)
    Description
    Monitor Nihon Kohden BSM-2301K
    Time Frame
    24 hours
    Title
    Heart rate (physiological parameter)
    Description
    Monitor Nihon Kohden BSM-2301K
    Time Frame
    24 hours
    Title
    Oxygen saturation (physiological parameter)
    Description
    Monitor Nihon Kohden BSM-2301K
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for abdominal hysterectomy Signing for informed consent Exclusion Criteria: Patients used with MAO inhibitor drugs (<14 days before surgery) History of substance abuse Hypersensitivity to opioids and others drugs of multimodal analgesia (metamizol and lidocaine) Pretreatment of any opioid (<7/2 lives of the drug in question) Chronic pain of any etiology (> 6 months) Diagnosis of bowel obstruction Renal or hepatic insufficiency Asthma, chronic obstructive pulmonary disease (COPD), and/ or hypothyroidism. Patients requiring general anesthesia for surgical complications
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    VIRGINIA A SANCHEZ, MD
    Phone
    3319837964
    Email
    aleyda_sanmis7@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Comparison of Adverse Drug Reactions Associated for Oxycodone and Morphine in Postoperative Pain After Abdominal Hysterectomy

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