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Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Duloxetine and Pregabalin
pregabalin
sham
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Pain

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria:

  • Patients aged from 18 to40 years.
  • ASA I-II.
  • undergoing elective mega -liposuction surgery
  • BMI from 18 to 50 kg/m2

    2. Exclusion criteria:

  • Patient refusal
  • Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs ASA III-IV.
  • Patients aged less than 18 or more than 40.
  • Body mass index >50.
  • Suffered from severe psychiatric disease or drug addiction;
  • Chronic opioid consumption,
  • a history of regular sedatives or anticonvulsants intake, serious organ disease or dysfunction
  • inability to use a PCA device
  • History of parenteral or oral analgesic intake within the last 48hours.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Sham Comparator

    Arm Label

    Patients in group I (PD group)

    patients in group II (P group)

    patients in group III (C groups)

    Arm Description

    Outcomes

    Primary Outcome Measures

    total morphine consumption by( mg ) over 5 day
    Postoperative morphine consumption mg

    Secondary Outcome Measures

    time to 1st request of rescue analgesia.
    Time to 1st request of rescue analgesia.
    Postoperative pain score
    visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain )
    total intraoperative fentanyl consumption (microgram) during surgery
    fentanyl used

    Full Information

    First Posted
    April 22, 2021
    Last Updated
    April 26, 2021
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04862845
    Brief Title
    Combination of Duloxetine and Pregabalin to Improve Postoperative Pain
    Official Title
    Effect of Combination of Duloxetine and Pregabalin to Improve Pain After Liposuction Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2021 (Anticipated)
    Primary Completion Date
    May 15, 2023 (Anticipated)
    Study Completion Date
    June 15, 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Postoperative pain is mediated by different mechanisms at multiple neural sites. Thus, multimodal analgesics can reduce the postoperative pain. Although Opioids are considered the analgesics of choice to treat moderate to severe pain, their use carries the risk of side effects and hyperalgesia. Multimodal analgesia can be achieved by combining different analgesics and different methods of administration, to provide better analgesia synergistically compared with conventional analgesia. Therefore,lower doses for each drug can be provided with fewer overall side-effects obtained from individual compounds. Recently, antidepressants such as duloxetine, a selective serotonin and norepinephrine reuptake inhibitor (SSNRI), have accomplished pain relief in persistent and chronic pain as in fibromyalgia, postherpetic neuralgia, diabetic neuropathy, osteoarthritis and musculoskeletal pain. The analgesic effect of duloxetine is attributed to its ability to enhance both serotonin and norepinephrine neurotransmission in descending inhibitory pain pathways. Moreover, some studies have promoted its use to improve the quality of recovery after surgery and reduce the acute postoperative pain after knee replacement surgery , mastectomy , hysterectomy , and after spine surgery. In addition it can improve postoperative quality of recovery through mood improvement that can be helpful in the postoperative period. The main objective of the present study was to examine perioperativelythe analgesic efficacy with the combination of duloxetine and prgabalinon postoperative pain when given as part of a multimodal pain strategy in patients undergoing surgery on liosuction. In addition to evaluating the patient's satisfaction and the adverse effects related to the combination of both medications.

    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
    Diagnostic
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients in group I (PD group)
    Arm Type
    Active Comparator
    Arm Title
    patients in group II (P group)
    Arm Type
    Active Comparator
    Arm Title
    patients in group III (C groups)
    Arm Type
    Sham Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine and Pregabalin
    Intervention Description
    will be received pregabalin with duloxetine 90 minutes preoperatively, then pregabalin every 12 hours with duloxetine once daily postoperatively until the fifth postoperative day.
    Intervention Type
    Drug
    Intervention Name(s)
    pregabalin
    Intervention Description
    received pregabalin with a placebo capsule at 90 minutes preoperatively, then every 12 hours postoperatively with a placebo capsule once daily until the fifth postoperative day.
    Intervention Type
    Drug
    Intervention Name(s)
    sham
    Intervention Description
    received two placebo capsules at 90 minutes preoperatively then placebo capsules every 12 hours, with one capsule daily postoperatively until the fifth postoperative day.
    Primary Outcome Measure Information:
    Title
    total morphine consumption by( mg ) over 5 day
    Description
    Postoperative morphine consumption mg
    Time Frame
    5 days
    Secondary Outcome Measure Information:
    Title
    time to 1st request of rescue analgesia.
    Description
    Time to 1st request of rescue analgesia.
    Time Frame
    24 hours
    Title
    Postoperative pain score
    Description
    visual analog scale (VAS) score of pain (0 being 'no pain' and '10' being the maximal worst pain )
    Time Frame
    24 hous
    Title
    total intraoperative fentanyl consumption (microgram) during surgery
    Description
    fentanyl used
    Time Frame
    24 hous

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria: Patients aged from 18 to40 years. ASA I-II. undergoing elective mega -liposuction surgery BMI from 18 to 50 kg/m2 2. Exclusion criteria: Patient refusal Contraindication or chronic use (consistent use for longer than 3 months) to any of the study drugs ASA III-IV. Patients aged less than 18 or more than 40. Body mass index >50. Suffered from severe psychiatric disease or drug addiction; Chronic opioid consumption, a history of regular sedatives or anticonvulsants intake, serious organ disease or dysfunction inability to use a PCA device History of parenteral or oral analgesic intake within the last 48hours.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Amr wahdan
    Phone
    01001422499
    Email
    amr_amw010@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Combination of Duloxetine and Pregabalin to Improve Postoperative Pain

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