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Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Electronic digital pressure algometer
Pain sensitivity questionnaire
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Postoperative Pain focused on measuring postoperative pain, pain sensitivity

Eligibility Criteria

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

Inclusion Criteria:

  • Age 18 years or above
  • Patients scheduled for open colorectal cancer surgery under general anesthesia
  • ASA status I-III
  • Ability to read and understand the information sheet, questionnaires, and the - consent form
  • Patients scheduled for using IV-PCA after surgery

Exclusion Criteria:

  • Unable to read and understand the information sheet, questionnaires, and the consent form
  • Severe medical or psychological diseases
  • Patients with preoperative chronic pain

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    study group

    Arm Description

    The following tests will be performed on the study subjects. Pain catastrophizing scale Hospital Anxiety and Depression scale-Anxiety Subscale (HADS-A) Pain sensitivity questionnaire Pain pressure threshold using electronic digital pressure algometer

    Outcomes

    Primary Outcome Measures

    Total fentanyl consumption during 24 hours
    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
    Total fentanyl consumption during 48 hours
    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

    Secondary Outcome Measures

    Postoperative pain score
    11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
    Patient satisfaction for postoperative pain management
    7-pointed likert scale (very satisfied-somewhat satisfied-satisfied-neutral-dissatisfied-somewhat dissatisfied-very dissatisfied)

    Full Information

    First Posted
    October 27, 2019
    Last Updated
    October 27, 2019
    Sponsor
    Seoul National University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04143672
    Brief Title
    Pain Sensitivity Questionnaire and Postoperative Opioid Requirement
    Official Title
    A Cohort Study on Association Between Pain Sensitivity by Pain Sensitivity Questionnaire and Postoperative Opioid Requirement
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    August 2020 (Anticipated)
    Study Completion Date
    October 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Seoul National University Hospital

    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
    This study aims to investigate the potential association between pain sensitivity questionnaire score, the severity of postoperative pain, and postoperative analgesic requirement in patients with open colorectal cancer surgery. This information may be used to guide the optimal postoperative pain management, and ultimately improve patient's quality of life.
    Detailed Description
    We plan to investigate the predictive ability of the PSQ as well as experimental parameters of pain sensitivity using electronic algometer and other known risk factors for postoperative pain in 100 patients scheduled for open colorectal cancer surgery. The following items are investigated before surgery; Age, sex, level of education, type of surgery, past surgical history, presence of chronic pain, the expected maximal pain score (VAS) after surgery, Pain catastrophizing scale, anxiety scale (HADS-A), Pain sensitivity questionnaire, and pain threshold measured by electronic algometer. The total opioid consumption is investigated for 24 and 48 hours after surgery. In addition, the severity of postoperative pain is measured by the 11-point VAS at 24 and 48 hours after surgery. Patient satisfaction with postoperative pain control is also investigated at 48 hours after surgery using the 7-point patient's satisfaction scale.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain
    Keywords
    postoperative pain, pain sensitivity

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Prospective observational study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    110 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    The following tests will be performed on the study subjects. Pain catastrophizing scale Hospital Anxiety and Depression scale-Anxiety Subscale (HADS-A) Pain sensitivity questionnaire Pain pressure threshold using electronic digital pressure algometer
    Intervention Type
    Device
    Intervention Name(s)
    Electronic digital pressure algometer
    Other Intervention Name(s)
    electronic digital pressure algometer (FGN-20B, Shimpo, Kyoto, Japan)
    Intervention Description
    Evaluation of pain threshold using an algometer is conducted one day before surgery. The pressure of the plunger of algometer is applied vertically to the patient's right thenar muscle belly at a speed of 10 N/sec by the tester. Then the tester removes the algometer when the patients start to feel pain and record the pressure recorded on the algometer.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Pain sensitivity questionnaire
    Intervention Description
    Evaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery.
    Primary Outcome Measure Information:
    Title
    Total fentanyl consumption during 24 hours
    Description
    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
    Time Frame
    postoperative 24 hours
    Title
    Total fentanyl consumption during 48 hours
    Description
    postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
    Time Frame
    postoperative 48 hours
    Secondary Outcome Measure Information:
    Title
    Postoperative pain score
    Description
    11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
    Time Frame
    postoperative 24, 48 hours
    Title
    Patient satisfaction for postoperative pain management
    Description
    7-pointed likert scale (very satisfied-somewhat satisfied-satisfied-neutral-dissatisfied-somewhat dissatisfied-very dissatisfied)
    Time Frame
    postoperative 48 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 18 years or above Patients scheduled for open colorectal cancer surgery under general anesthesia ASA status I-III Ability to read and understand the information sheet, questionnaires, and the - consent form Patients scheduled for using IV-PCA after surgery Exclusion Criteria: Unable to read and understand the information sheet, questionnaires, and the consent form Severe medical or psychological diseases Patients with preoperative chronic pain
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jintae Kim, MD, PhD
    Phone
    82-2-2072-3295
    Email
    jintae73@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hojin Lee, MD
    Phone
    82-2-2072-2467
    Email
    zenerdiode03@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jintae Kim, MD, PhD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

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