Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Device: Electronic digital pressure algometer; Diagnostic Test: Pain sensitivity questionnaire

• Registration Number: NCT04143672
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Status Verified: 2019-10
• Study First Submitted: 2019-10-27
• Study First Submitted QC: 2019-10-27
• Last Update Submitted: 2019-10-27
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29
• Study Start: 2019-11
• Primary Completion: 2020-08
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
study group	Pain sensitivity questionnaire	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
study group	Electronic digital pressure algometer	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

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption during 24 hours	postoperative 24 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia
Total fentanyl consumption during 48 hours	postoperative 48 hours	postoperative fentanyl consumption (mcg) via IV patient controlled analgesia

Secondary Outcome Measures

Name	Time	Method
Postoperative pain score	postoperative 24, 48 hours	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	postoperative 48 hours	7-pointed likert scale (very satisfied-somewhat satisfied-satisfied-neutral-dissatisfied-somewhat dissatisfied-very dissatisfied)