Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

NCT ID: NCT04143672

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2020-10-31

Brief Summary

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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

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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

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Postoperative Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective observational study
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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study group

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

Group Type EXPERIMENTAL

Electronic digital pressure algometer

Intervention Type DEVICE

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 questionnaire

Intervention Type DIAGNOSTIC_TEST

Evaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery.

Interventions

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Electronic digital pressure algometer

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 DEVICE

Pain sensitivity questionnaire

Evaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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electronic digital pressure algometer (FGN-20B, Shimpo, Kyoto, Japan)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jintae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Central Contacts

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Jintae Kim, MD, PhD

Role: CONTACT

82-2-2072-3295

Hojin Lee, MD

Role: CONTACT

82-2-2072-2467

Other Identifiers

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SNUH-HJ-1

Identifier Type: -

Identifier Source: org_study_id

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