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Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement

Primary Purpose

Intrathecal Morphine, Intrathecal Morphine-dexmedetomidine Combination, Postoperative Pain Control

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexmedetomidine
Morphine
Dexmedetomidine
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrathecal Morphine

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia

Exclusion Criteria:

  1. Patients who had bleeding disorders
  2. Patients who had heart, liver, or renal failure
  3. Patients who had systemic infections or infections of their injection sites
  4. Patients with a known allergy to study
  5. Patients who had 2nd or 3rd-degree heart block
  6. Those with low back pain or other back problems
  7. History of drug or alcohol abuse
  8. Body mass index (BMI) > 30 kg\m2
  9. Patients with 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

    Placebo Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group morphine

    Group morphine-Dex

    Group Dex

    Arm Description

    Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.

    Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.

    Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.

    Outcomes

    Primary Outcome Measures

    The onset of pain
    The onset of pain is defined as VAS ≥ 4 within 24 hours

    Secondary Outcome Measures

    Postoperative pain severity
    VAS ≥ 4 within 24 hours
    The amount of additional analgesic required
    Patients with VAS ≥ 4 will be received 3 mg morphine IV. Patients who complained of pain (VAS < 3) and needed analgesics will be treated with intravenous infusion every six to eight hours with Diclofenac Na(75mg).
    Postoperative complications
    the incidence of PONV, respiratory depression, and itching.

    Full Information

    First Posted
    June 26, 2022
    Last Updated
    June 30, 2022
    Sponsor
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05439564
    Brief Title
    Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
    Official Title
    Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2022 (Anticipated)
    Primary Completion Date
    December 30, 2022 (Anticipated)
    Study Completion Date
    January 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Total knee replacement is one of the most painful orthopedic surgical procedures. Patients who undergo total knee replacement are usually older and have limited cardiac and pulmonary reserves. The increased sensitivity of elderly patients to drugs makes it necessary to choose postoperative analgesia agents and methods that have minimal side effects. Intrathecal injection of morphine to provide postoperative analgesia during the initial 24-h after the operation is a widely used technique, however, opioid therapy is limited because of the side effects (hypotension, pruritus, nausea, urinary retention, respiratory depression) and intolerance. Alpha-2 adrenergic agonists (clonidine and dexmedetomidine) have pharmacologic characteristics (sedation, hypnosis, anxiolysis, sympatholytic, and analgesia) that make them suitable as adjuvants to multimodal analgesia. Their anti-nociceptive effect is attributed to the stimulation of a2- adrenoceptors located in the central nervous system. The rationale for combining analgesics that produce similar therapeutic effects or synergistic interactions is to accentuate the analgesic efficacy and decrease the side effects by permitting dose reduction of each agent. Human studies on the antinociceptive effects of co-administrated intrathecal morphine (ITM) and dexmedetomidine in postoperative pain are still few. On the other hand, Abdel-Ghaffar et al., results do not support improved analgesia with the combination of intrathecal morphine and dexmedetomidine, despite the absence of significant adverse effects. We hypothesized that the addition of dexmedetomidine to ITM would improve the quality of perioperative pain control and decrease the side effects of postoperative systemic opioid use.
    Detailed Description
    105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia will be included in this study. 105 Patients will be randomly allocated into three equal groups (35 patients each): Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine. Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine. Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine Measurements: Demographic data as age, BMI, ASA status, duration of surgery During surgery, systolic blood pressure (SBP), diastolic blood pressure (DBP), and heart rate (HR) will be recorded at the 1st, 5th, 15th, 30th, and 60th minutes. Postoperative pain severity assessed by the visual analog score for pain at rest (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively at 30 min and 2, 4, 6, 12, and 24 h postoperative. Accordingly, the patient is requested to verbally express his degree of pain using this scale. Patients with the visual analog score≥ 4 will be received 3 mg morphine IV and will be recorded. Patients who complained of pain (the visual analog score< 3) and needed analgesics will be treated intravenous infusion every six to eight hours with Diclofenac Na(75mg). The total dose of morphine used postoperatively will be observed and recorded for the 1st, 2nd, 6th, 12th, and 24th postoperative hours. The period from the moment the intrathecal injection will be made postoperatively until the first analgesic became necessary will be recorded Any recorded postoperative complication as sedation, nausea and vomiting, respiratory depression. The patient's level of sedation will be assessed at the same time points using Ramsay Sedation Scale (score 3-4 mean adequate sedation). (17)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intrathecal Morphine, Intrathecal Morphine-dexmedetomidine Combination, Postoperative Pain Control, Total Knee Replacement

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    105 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group morphine
    Arm Type
    Placebo Comparator
    Arm Description
    Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
    Arm Title
    Group morphine-Dex
    Arm Type
    Active Comparator
    Arm Description
    Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
    Arm Title
    Group Dex
    Arm Type
    Active Comparator
    Arm Description
    Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Other Intervention Name(s)
    morphine
    Intervention Description
    Group morphine-Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine plus 5 mcg of dexmedetomidine.
    Intervention Type
    Drug
    Intervention Name(s)
    Morphine
    Intervention Description
    Group morphine (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 0.1 mg of morphine.
    Intervention Type
    Drug
    Intervention Name(s)
    Dexmedetomidine
    Intervention Description
    Group Dex (35 patients): patients will be received given 0.5% heavy bupivacaine (3.5 ml) plus 5 mcg of dexmedetomidine.
    Primary Outcome Measure Information:
    Title
    The onset of pain
    Description
    The onset of pain is defined as VAS ≥ 4 within 24 hours
    Time Frame
    upto 24 hours postoperative
    Secondary Outcome Measure Information:
    Title
    Postoperative pain severity
    Description
    VAS ≥ 4 within 24 hours
    Time Frame
    upto 24 hours postoperative
    Title
    The amount of additional analgesic required
    Description
    Patients with VAS ≥ 4 will be received 3 mg morphine IV. Patients who complained of pain (VAS < 3) and needed analgesics will be treated with intravenous infusion every six to eight hours with Diclofenac Na(75mg).
    Time Frame
    upto 24 hours postoperative
    Title
    Postoperative complications
    Description
    the incidence of PONV, respiratory depression, and itching.
    Time Frame
    upto 24 hours postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 105 patients, aged >50 years, with ASA Physical Status Class II and III, scheduled for TKR under spinal anesthesia Exclusion Criteria: Patients who had bleeding disorders Patients who had heart, liver, or renal failure Patients who had systemic infections or infections of their injection sites Patients with a known allergy to study Patients who had 2nd or 3rd-degree heart block Those with low back pain or other back problems History of drug or alcohol abuse Body mass index (BMI) > 30 kg\m2 Patients with psychiatric illnesses that would interfere with perception and assessment of pain.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intrathecal Morphine Versus Morphine-dexmedetomidine Combination for Postoperative Pain Control After Total Knee Replacement

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