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
About this trial
This is an interventional screening trial for Postoperative Pain focused on measuring postoperative pain, pain sensitivity
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
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
NCT ID
NCT04143672
First Posted
October 27, 2019
Last Updated
October 27, 2019
Sponsor
Seoul National University Hospital
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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