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Local Ketamine Instillation for Postoperative Analgesia

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
intra-wound instillation of ketamine
intra-wound instillation of normal saline
systemic administration of ketamine
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative analgesia, ketamine, total thyroidectomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with thyroid cancer scheduled for total thyroidectomy.

Exclusion Criteria:

  1. BMI>35
  2. Unstable ischaemic cardiac disease
  3. Increased intracranial pressure
  4. Increased intraocular pressure
  5. Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study.
  6. Severe psychiatric disease
  7. Unwillingness or inability to use PCA-device
  8. Inability to use VAS scale

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    local ketamine group

    control group

    systemic ketamine group

    Arm Description

    intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

    intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.

    Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.

    Outcomes

    Primary Outcome Measures

    total opioid consumption
    the total amount of morphine consumed during follow up period

    Secondary Outcome Measures

    first request of analgesia
    time to first request of rescue analgesic drug
    VAS
    effect of study drugs on postoperative pain measured by VAS score

    Full Information

    First Posted
    December 24, 2015
    Last Updated
    January 1, 2017
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02642497
    Brief Title
    Local Ketamine Instillation for Postoperative Analgesia
    Official Title
    Efficacy of Postoperative Analgesia Offered by Local Ketamine Wound Instillation Following Total Thyroidctomy; a Randomized, Double-blind, Controlled-clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2015 (undefined)
    Primary Completion Date
    February 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims at exploring the analgesic efficacy, and safety of Ketamine instillation into the wound of total thyroidectomy compared to placebo,and to systemic ketamine administration (I.M. injection of the same dose) with respect to postoperative VAS, first request of analgesia, total opioid consumption, and with respect to possible side effects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    postoperative analgesia, ketamine, total thyroidectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    90 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    local ketamine group
    Arm Type
    Active Comparator
    Arm Description
    intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.
    Arm Title
    control group
    Arm Type
    Placebo Comparator
    Arm Description
    intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure, with closure of suction drain tube for 30 min. postoperatively.
    Arm Title
    systemic ketamine group
    Arm Type
    Active Comparator
    Arm Description
    Intra-muscular injection of ketamine at a dose of 1 mg/kg before wound closure.
    Intervention Type
    Drug
    Intervention Name(s)
    intra-wound instillation of ketamine
    Intervention Description
    intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
    Intervention Type
    Drug
    Intervention Name(s)
    intra-wound instillation of normal saline
    Other Intervention Name(s)
    placebo
    Intervention Description
    intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
    Intervention Type
    Drug
    Intervention Name(s)
    systemic administration of ketamine
    Intervention Description
    intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.
    Primary Outcome Measure Information:
    Title
    total opioid consumption
    Description
    the total amount of morphine consumed during follow up period
    Time Frame
    24 hours
    Secondary Outcome Measure Information:
    Title
    first request of analgesia
    Description
    time to first request of rescue analgesic drug
    Time Frame
    24 hours
    Title
    VAS
    Description
    effect of study drugs on postoperative pain measured by VAS score
    Time Frame
    24 hours
    Other Pre-specified Outcome Measures:
    Title
    possible side effects
    Description
    occurrence of possible side effects during follow up
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with thyroid cancer scheduled for total thyroidectomy. Exclusion Criteria: BMI>35 Unstable ischaemic cardiac disease Increased intracranial pressure Increased intraocular pressure Hypersensitivity or allergy to ketamine, local anesthetic, morphine, or other drugs used in the study. Severe psychiatric disease Unwillingness or inability to use PCA-device Inability to use VAS scale

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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