Pain Sensitivity Questionnaire and Postoperative Opioid Requirement

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Device: Electronic digital pressure algometer; Diagnostic test: Pain sensitivity questionnaire

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: study group; The following tests will be performed on the study subjects.; Pain catastrophizing scale; Hospital Anxiety and Depression scale-Anxiety Subscale (HADS-A); Pain sensitivity questionnaire; Pain pressure threshold using electronic digital pressure algometer

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.; Other Names: electronic digital pressure algometer (FGN-20B, Shimpo, Kyoto, Japan); Diagnostic test: Pain sensitivity questionnaire; Evaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Patient satisfaction for postoperative pain management	7-pointed likert scale (very satisfied-somewhat satisfied-satisfied-neutral-dissatisfied-somewhat dissatisfied-very dissatisfied)	postoperative 48 hours

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Jintae Kim, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: October 27, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 27, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: postoperative pain; pain sensitivity
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Hypersensitivity; Pain, Postoperative
• Other Study ID Numbers: SNUH-HJ-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No