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Systemic Nalbuphine Versus Intravenous Regional Anesthesia

Primary Purpose

Postoperative Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Systemic nalbuphine
Local nalbuphine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients scheduled for elective unilateral hand surgery.

Exclusion Criteria:

  • Patient refusal.
  • Allergy to study medications
  • Body mass index > 35 kg/ m2
  • Patients with sickle cell or Reynaud diseases
  • Patients with a history of psychiatric illness or on chronic opioids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Systemic nalbuphine group

    Local nalbuphine group

    Arm Description

    53 patients will receive nalbuphine systemically

    53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA)

    Outcomes

    Primary Outcome Measures

    Duration of postoperative Analgesia
    minutes

    Secondary Outcome Measures

    Diclofenac analgesic consumption
    mg
    Cortisol level
    Level of cortisone in blood (nmol/L)
    Severity of postoperative Pain
    Visual Analogue Scale (VAS)

    Full Information

    First Posted
    May 8, 2017
    Last Updated
    February 24, 2022
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03150732
    Brief Title
    Systemic Nalbuphine Versus Intravenous Regional Anesthesia
    Official Title
    Comparison of Systemic Nalbuphine Versus Intravenous Regional Anesthesia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 10, 2022 (Anticipated)
    Primary Completion Date
    December 10, 2022 (Anticipated)
    Study Completion Date
    June 10, 2023 (Anticipated)

    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

    5. Study Description

    Brief Summary
    Comparison of systemic nalbuphine versus intravenous regional anesthesia in patients undergoing hand surgery.

    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
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Two groups
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    106 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Systemic nalbuphine group
    Arm Type
    Active Comparator
    Arm Description
    53 patients will receive nalbuphine systemically
    Arm Title
    Local nalbuphine group
    Arm Type
    Active Comparator
    Arm Description
    53 patients will receive nalbuphine with local intravenous regional anesthesia (IVRA)
    Intervention Type
    Drug
    Intervention Name(s)
    Systemic nalbuphine
    Intervention Description
    Patients will receive systemic nalbuphine 10 mg
    Intervention Type
    Drug
    Intervention Name(s)
    Local nalbuphine
    Intervention Description
    Patients will receive local nalbuphine 10 mg
    Primary Outcome Measure Information:
    Title
    Duration of postoperative Analgesia
    Description
    minutes
    Time Frame
    Postoperative 24 hours
    Secondary Outcome Measure Information:
    Title
    Diclofenac analgesic consumption
    Description
    mg
    Time Frame
    Postoperative 24 hours
    Title
    Cortisol level
    Description
    Level of cortisone in blood (nmol/L)
    Time Frame
    Preoperative and at 4 hours after skin incision
    Title
    Severity of postoperative Pain
    Description
    Visual Analogue Scale (VAS)
    Time Frame
    Postoperative 24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients scheduled for elective unilateral hand surgery. Exclusion Criteria: Patient refusal. Allergy to study medications Body mass index > 35 kg/ m2 Patients with sickle cell or Reynaud diseases Patients with a history of psychiatric illness or on chronic opioids
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Eman Ismail
    Phone
    +20882413201
    Email
    emanismail97@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Systemic Nalbuphine Versus Intravenous Regional Anesthesia

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