Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

Postoperative Pain Clinical Trial

Official title:

A Cohort Study on Association Between Pain Sensitivity by Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04143672
• Other study ID #: SNUH-HJ-1
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: October 2020

Study information

• Verified date: October 2019
• Source: Seoul National University Hospital
• Contact: Jintae Kim, MD, PhD
• Phone: 82-2-2072-3295
• Email: jintae73[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This information may be used to guide the optimal postoperative pain management, and ultimately improve patient's quality of life.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: October 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypersensitivity
• Pain, Postoperative
• Postoperative Pain

Intervention

Device:
• 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.

Diagnostic Test:
• Pain sensitivity questionnaire
Evaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fentanyl consumption during 24 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	postoperative 24 hours
Primary	Total fentanyl consumption during 48 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia	postoperative 48 hours
Secondary	Postoperative pain score	11-pointed NRS pain score at resting/coughing/movement NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"	postoperative 24, 48 hours
Secondary	Patient satisfaction for postoperative pain management	7-pointed likert scale (very satisfied-somewhat satisfied-satisfied-neutral-dissatisfied-somewhat dissatisfied-very dissatisfied)	postoperative 48 hours