Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

NCT04143672 | Unknown DMC

• 1 other identifier: SNUH-HJ-1
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Postoperative Pain

Keywords

postoperative pain; pain sensitivity

Outcome Measures

Primary Outcomes (2)

• Total fentanyl consumption during 24 hours

  postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  postoperative 24 hours

• Total fentanyl consumption during 48 hours

  postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

  postoperative 48 hours

Secondary Outcomes (2)

• Postoperative pain score

  postoperative 24, 48 hours

• Patient satisfaction for postoperative pain management

  postoperative 48 hours

Study Arms (1)

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

Device: Electronic digital pressure algometer; Diagnostic Test: Pain sensitivity questionnaire

Interventions

Electronic digital pressure algometer 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.

Also known as: electronic digital pressure algometer (FGN-20B, Shimpo, Kyoto, Japan)

study group

Pain sensitivity questionnaire DIAGNOSTIC_TEST

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

study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jintae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jintae Kim, MD, PhD

CONTACT

82-2-2072-3295; jintae73@gmail.com

Hojin Lee, MD

CONTACT

82-2-2072-2467; zenerdiode03@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective observational study

Study Record Dates

• First Submitted: October 27, 2019
• First Posted: October 29, 2019
• Study Start: November 1, 2019
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 29, 2019

Record last verified: 2019-10