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Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine

Primary Purpose

Inguinal Hernia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring nalbuphine, morphine, IV, Intrathecal

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: patients of aged 15-70years old males Scheduled patients for inguinal hernia repair surgery with under spinal anesthesia. ASA grade 1,2 normal cardiac and renal function Exclusion Criteria: Patient refusal Allergy to the studied drugs. Patients with contraindications to spinal anesthesia ASA grade 3,4

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    group (1)

    group (2)

    Arm Description

    who given intrathecal morphine thin IV nalbuphine and asize of 80 patients

    who given intrathecal morphine onInguinal hernia druing spinal anathesia

    Outcomes

    Primary Outcome Measures

    Effect of IV nalbuphine on postoperative nausea and vomiting following intrathecal morphine in patients undergoing inguinal hernia repair
    investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery. A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea to 3 sever vomating). A verbal descriptive scale (VDS) was used to assess the severity of PONV b. Secondary (subsidiary): postoperative pain and puririts. [ Time Frame: 24 hours ] c. Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 3).

    Secondary Outcome Measures

    Full Information

    First Posted
    January 20, 2023
    Last Updated
    May 5, 2023
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05704673
    Brief Title
    Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine
    Official Title
    Effect of IV Nalbuphine on Postoperative Nausea and Vomiting Following Intrathecal Morphine in Patients Undergoing Inguinal Hernia Repair
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    June 2024 (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

    5. Study Description

    Brief Summary
    the study aimed to investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
    Detailed Description
    Bupivacaine hydrochloride is a commonly used local anesthetic in spinal anesthesia, however, the duration of spinal analgesia by bupivacaine is limited to about 75- 150 minutes.2 Therefore, various additives have been used with bupivacaine to prolong its effects and improve the quality of analgesia.(1) Opioids are the most popular used adjuvants added to bupivacaine in spinal blockade to obtain a sufficient intraoperative visceral analgesia and increase the duration and quality of postoperative analgesia, with less sympathetic block and hemodynamic effect .(2) morphine is commonly used for analgesia, but is frequently associated with postoperative nausea and vomiting (PONV) and pruritus, These side effects may lead to patient discomfort and prolonged hospital stay thus limiting the usefulness of IT morphine. Nalbuphine is a mu receptor antagonist and a ĸappa receptor agonist.10 When added as an adjunct to intrathecal local anesthetics, it provides good analgesia with decreased incidence and severity of mu receptor side effects(3) Morphine binds most readily to the mu-opioid receptor and less well to the kappa-opioid receptor. So, the undesirable adverse events of morphine are thought to result from agonism at the mu-opioid receptor.5 Many drugs have been tried with morphine to potentiate its analgesic effects or to reduce the adverse events.6 Nalbuphine is a mixed opioid agonist-antagonist that acts mainly through kappa-opioid receptors, and it may attenuate mu-opioid receptor related side effects.3 Moreover, recent studies suggested that the analgesic effects of morphine and nalbuphine may be additive. The addition of nalbuphine to intrathecal bupivacaine plus morphine significantly reduced the incidence and severity of postoperative nausea and vomiting and pruritus without affecting analgesic potency..(4)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inguinal Hernia
    Keywords
    nalbuphine, morphine, IV, Intrathecal

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group (1)
    Arm Type
    Active Comparator
    Arm Description
    who given intrathecal morphine thin IV nalbuphine and asize of 80 patients
    Arm Title
    group (2)
    Arm Type
    Placebo Comparator
    Arm Description
    who given intrathecal morphine onInguinal hernia druing spinal anathesia
    Intervention Type
    Drug
    Intervention Name(s)
    nalbuphine on N and V and pain with intrathecal morphine onInguinal hernia repair surgery. randomized, prospective, double blinded and placebo-controlled trial study.
    Other Intervention Name(s)
    nalbuphine, intrathecal morphine
    Intervention Description
    investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery.
    Primary Outcome Measure Information:
    Title
    Effect of IV nalbuphine on postoperative nausea and vomiting following intrathecal morphine in patients undergoing inguinal hernia repair
    Description
    investigate the effect of Iv nalbuphine on postoperative nausea and vomiting and pain with intrathecal morphine on inguinal hernia repair surgery. A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea to 3 sever vomating). A verbal descriptive scale (VDS) was used to assess the severity of PONV b. Secondary (subsidiary): postoperative pain and puririts. [ Time Frame: 24 hours ] c. Visual analogue scale (VAS) pain scores (no pain = 0, worst possible pain = 3).
    Time Frame
    1. a. Primary (main): postoperative nausea and vomiting [ Time Frame: 24 hours ] A verbal descriptive scale (VDS) was used to assess the severity of PONV. ( no nausea=0, severe nausea= 3 by postoperative nausea and vomiting scale which range (o no nasuea

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    males
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: patients of aged 15-70years old males Scheduled patients for inguinal hernia repair surgery with under spinal anesthesia. ASA grade 1,2 normal cardiac and renal function Exclusion Criteria: Patient refusal Allergy to the studied drugs. Patients with contraindications to spinal anesthesia ASA grade 3,4
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rehab Marzouk, master
    Phone
    01022290058
    Email
    e01022290058@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Prof. Fatma Asker, Professor
    Phone
    01005803969
    Email
    F.askar@aun.edu.eg

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    29856176
    Citation
    Ibrahim AS, Aly MG, Thabet ME, Abdelaziz MR. Effect of adding nalbuphine to intrathecal bupivacaine with morphine on postoperative nausea and vomiting and pruritus after elective cesarean delivery: a randomized double blinded study. Minerva Anestesiol. 2019 Mar;85(3):255-262. doi: 10.23736/S0375-9393.18.12751-9. Epub 2018 May 30.
    Results Reference
    result

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    Effect of IV Nalbuphine on Nausea and Vomiting Following Intrathecal Morphine

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