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The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients scheduled for total knee replacement surgery.
  2. ASA Physical status I,II,III.

Exclusion Criteria

  1. Patients' refusal.
  2. Uncooperative patients / Not able to understand pain assessment test.
  3. Patients with history of allergy to the used drugs.
  4. Significant liver disease.
  5. Pregnancy.
  6. Any contraindication for epidural anesthesia
  7. Failed technique.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    controlled group

    dexamethasone group

    Arm Description

    Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).

    Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)

    Outcomes

    Primary Outcome Measures

    duration of postoperative analgesia (NRS)
    first patient request for analgesia or NRS 4 or more

    Secondary Outcome Measures

    Full Information

    First Posted
    July 25, 2017
    Last Updated
    August 1, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03231215
    Brief Title
    The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery
    Official Title
    The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 3, 2016 (Actual)
    Primary Completion Date
    June 2017 (Actual)
    Study Completion Date
    July 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the efficacy of dexamethasone when added to epidural bupivacaine on the duration of postoperative analgesia in patients underwent total knee replacement surgery.
    Detailed Description
    Fifty patients underwent total knee replacement were included in the study. The patients (11 male and 39 female) were classified into two equal groups:- The patients received 15 mL plain bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups was 17 ml. Postoperative records: Pain score (NRS) at base line, then every 4 hrs for 24 hrs. Frequency of rescue analgesia. Postoperative side effects like nausea, vomiting, and over sedation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    controlled group
    Arm Type
    Placebo Comparator
    Arm Description
    Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).
    Arm Title
    dexamethasone group
    Arm Type
    Active Comparator
    Arm Description
    Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)
    Intervention Type
    Drug
    Intervention Name(s)
    Dexamethasone
    Other Intervention Name(s)
    Decadrone
    Intervention Description
    dexamethasone + plain Bupivacaine injected epidurally.
    Primary Outcome Measure Information:
    Title
    duration of postoperative analgesia (NRS)
    Description
    first patient request for analgesia or NRS 4 or more
    Time Frame
    24 hrs postoperative

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for total knee replacement surgery. ASA Physical status I,II,III. Exclusion Criteria Patients' refusal. Uncooperative patients / Not able to understand pain assessment test. Patients with history of allergy to the used drugs. Significant liver disease. Pregnancy. Any contraindication for epidural anesthesia Failed technique.

    12. IPD Sharing Statement

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    The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery

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