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Combined Intrathecal Morphine and Dexmedetomidine Analgesia (ITMandDEX)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Dexmedetomidine (Precedex)
Bupivacaine
Morphine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring analgesia, intrathecal, opioids, morphine, dexmedetomidine

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy)

Exclusion Criteria:

  • known allergy to study drugs
  • Significant cardiac, respiratory, renal or hepatic disease.
  • 2nd or 3rd degree heart block.
  • Coagulation disorders.
  • Low back pain or other back problems.
  • Drug or alcohol abuse.
  • BMI>30kg\m2.
  • Psychiatric illnesses that would interfere with perception and assessment of pain.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Intrathecal Bupivacaine

    Intrathecal Morphine

    Intrathecal Morphine-Dex

    Arm Description

    intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9%

    intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume

    intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .

    Outcomes

    Primary Outcome Measures

    total dose of intravenous PCA morphine consumption in the first 48 h postoperative
    Calculating the cumulative intravenous PCA morphine dose

    Secondary Outcome Measures

    Noninvasive blood pressure
    non invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
    Heart rate
    non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative
    peripheral arterial oxygen saturation
    assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative
    postoperative VAS scores
    assessment of pain scores on admission to surgical intensive care unit and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
    time to first request for analgesia
    measuring the time in hours of first request for intravenous PCA morphine

    Full Information

    First Posted
    April 26, 2015
    Last Updated
    May 5, 2015
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02435537
    Brief Title
    Combined Intrathecal Morphine and Dexmedetomidine Analgesia
    Acronym
    ITMandDEX
    Official Title
    Safety and Efficacy of Dexmedetomidine Addition to Intrathecal Morphine for Postoperative Analgesia in Cancer Patients Undergoing Major Abdominal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2013 (undefined)
    Primary Completion Date
    March 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The current study investigated the effect of adding dexmedetomidine to intrathecal morphine for postoperative analgesia in cancer patients undergoing major abdominal surgery.
    Detailed Description
    Opioids, administered intrathecal or epidural, are widely used for postoperative, and chronic nociceptive pain secondary to cancers. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24 h after operation is a widely used technique.The Human studies on the antinociceptive effects of co-administrated intrathecal morphine and dexmedetomidine in postoperative pain are still lacking. In this study, the investigators aimed to compare the synergistic interaction and side-effects of combined intrathecal morphine and dexmedetomidine with either drug alone for postoperative analgesia in cancer patients undergoing major abdominal surgery. Patients were randomly allocated into three groups of 30 patients each to receive either; hyperbaric bupivacaine 0.5% (Group I/Bupivacaine Group), bupivacaine and 0.5 mg morphine (Group II/Morphine Group), bupivacaine and 0.5 mg morphine plus 5 µg of dexmedetomidine (Group III/Morphine-DEX Group). The assigned drugs were dissolved in 1ml physiological saline and administered intrathecal with bupivacaine before induction of general anesthesia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    analgesia, intrathecal, opioids, morphine, dexmedetomidine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intrathecal Bupivacaine
    Arm Type
    Active Comparator
    Arm Description
    intrathecal injection of 10 mg hyperbaric bupivacaine 0.5% in 2 ml volume and 1ml of saline 0.9%
    Arm Title
    Intrathecal Morphine
    Arm Type
    Active Comparator
    Arm Description
    intrathecal injection of 10mg bupivacaine 0.5% in 2ml volume intrathecal injection of 0.5 mg morphine in 1ml volume
    Arm Title
    Intrathecal Morphine-Dex
    Arm Type
    Active Comparator
    Arm Description
    intrathecal 10mg bupivacaine 0.5% in 2 ml volume intrathecal 0.5 mg morphine intrathecal 5 µg of dexmedetomidine in 1ml volume .
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine (Precedex)
    Other Intervention Name(s)
    Precedex
    Intervention Description
    intrathecal administration
    Intervention Type
    Drug
    Intervention Name(s)
    Bupivacaine
    Other Intervention Name(s)
    Buvicaine
    Intervention Description
    intrathecal 10 mg bupivacaine
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Other Intervention Name(s)
    morphine sulphate
    Intervention Description
    intrathecal 0.5mg morphine
    Primary Outcome Measure Information:
    Title
    total dose of intravenous PCA morphine consumption in the first 48 h postoperative
    Description
    Calculating the cumulative intravenous PCA morphine dose
    Time Frame
    48 hours
    Secondary Outcome Measure Information:
    Title
    Noninvasive blood pressure
    Description
    non invasive systolic and diastolic blood pressure intra-operative and postoperative in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
    Time Frame
    48 hours
    Title
    Heart rate
    Description
    non invasive assessment of heart rate in the 6th, 12th, 18th, 24th, 36th, and 48th postoperative. intraoperative and postoperative
    Time Frame
    48 hours
    Title
    peripheral arterial oxygen saturation
    Description
    assessment of pulse oximetry intraoperative and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative
    Time Frame
    48 hours
    Title
    postoperative VAS scores
    Description
    assessment of pain scores on admission to surgical intensive care unit and in the 6th, 12th, 18th, 24th, 36th, and 48th h postoperative.
    Time Frame
    48 hours
    Title
    time to first request for analgesia
    Description
    measuring the time in hours of first request for intravenous PCA morphine
    Time Frame
    48hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - major abdominal cancer surgery (e.g. hemi-colectomy or cystectomy) Exclusion Criteria: known allergy to study drugs Significant cardiac, respiratory, renal or hepatic disease. 2nd or 3rd degree heart block. Coagulation disorders. Low back pain or other back problems. Drug or alcohol abuse. BMI>30kg\m2. Psychiatric illnesses that would interfere with perception and assessment of pain.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Saher AB Mohamed, MD
    Organizational Affiliation
    Assisstant professor in Anesthesia and intensive care department, South Egypt Cancer institute, Assiut university, Egypt
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hala s Abdel-Ghaffar, MD
    Organizational Affiliation
    Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    27002003
    Citation
    Abdel-Ghaffar HS, Mohamed SA, Fares KM. Combined Intrathecal Morphine and Dexmedetomidine for Postoperative Analgesia in Patients Undergoing Major Abdominal Cancer Surgery. Pain Med. 2016 Nov;17(11):2109-2118. doi: 10.1093/pm/pnw031. Epub 2016 Mar 21.
    Results Reference
    derived

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    Combined Intrathecal Morphine and Dexmedetomidine Analgesia

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