Postoperative PainNCT04143672
Pain Sensitivity Questionnaire and Postoperative Opioid Requirement
A study testing Electronic digital pressure algometer and Pain sensitivity questionnaire in people with Postoperative Pain, run by Seoul National University Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Electronic digital pressure algometer and Pain sensitivity questionnaire
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to read and understand the information sheet, questionnaires, and the consent form
- Severe medical or psychological diseases
- Patients with preoperative chronic pain
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Cohort Study on Association Between Pain Sensitivity by Pain Sensitivity Questionnaire and Postoperative Opioid Requirement
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.
Read the 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.
- Conditions
- Postoperative Pain
- Being tested
- Electronic digital pressure algometer, Pain sensitivity questionnaire
- Keywords
- postoperative pain, pain sensitivity
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic digital pressure algometerDevice
Also called electronic digital pressure algometer (FGN-20B, Shimpo, Kyoto, Japan)
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.
Pain sensitivity questionnaireDiagnostic test
Evaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery.
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | The following tests will be performed on the study subjects.
1. Pain catastrophizing scale
2. Hospital Anxiety and Depression scale-Anxiety Subscale (HADS-A)
3. Pain sensitivity questionnaire
4. Pain pressure threshold using electronic digital pressure algometer Receives: Device: Electronic digital pressure algometer; Diagnostic Test: Pain sensitivity questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fentanyl consumption during 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Measured: postoperative 24 hours
Total fentanyl consumption during 48 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Measured: postoperative 48 hours
Secondary outcomes (2)
Postoperative pain score
11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
Measured: postoperative 24, 48 hours
Patient satisfaction for postoperative pain management
7-pointed likert scale (very satisfied-somewhat satisfied-satisfied-neutral-dissatisfied-somewhat dissatisfied-very dissatisfied)
Measured: postoperative 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study startNov 2019 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective observational study
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jintae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143672
- Sponsor's protocol ID
- SNUH-HJ-1
- Status last verified
- Oct 2019
- First submitted
- 27 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cohort Study on Association Between Pain Sensitivity by Pain Sensitivity Questionnaire and Postoperative Opioid Requirement
- ClinicalTrials.gov ID
- NCT04143672
- Acronym / sponsor ID
- SNUH-HJ-1
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, pain sensitivity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Nov 2019 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective observational study
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: Electronic digital pressure algometer, Diagnostic Test: Pain sensitivity questionnaireThe following tests will be performed on the study subjects. 1. Pain catastrophizing scale 2. Hospital Anxiety and Depression scale-Anxiety Subscale (HADS-A) 3. Pain sensitivity questionnaire 4. Pain pressure threshold using electronic digital pressure algometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to read and understand the information sheet, questionnaires, and the consent form
- Severe medical or psychological diseases
- Patients with preoperative chronic pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic digital pressure algometerAlso: electronic digital pressure algometer (FGN-20B, Shimpo, Kyoto, Japan)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. | Device | study group |
| Pain sensitivity questionnaireEvaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery. | Diagnostic test | study group |
Primary outcome
Total fentanyl consumption during 24 hours
Time frame: postoperative 24 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Total fentanyl consumption during 48 hours
Time frame: postoperative 48 hours
postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
2 secondary outcomes
Postoperative pain score
Time frame: postoperative 24, 48 hours
Patient satisfaction for postoperative pain management
Time frame: postoperative 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jintae Kim, MD, PhD principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Electronic digital pressure algometer and Pain sensitivity questionnaire in people with Postoperative Pain, run by Seoul National University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jintae Kim, MD, PhD (82-2-2072-3295, jintae73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fentanyl consumption during 24 hours (time frame: postoperative 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.