NOCTURNAL PAIN After Knee Arthroplasty : Incidence and Risk Factor: an Observational Study (NOCTURN-PAIN)

In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain. The purpose of our study is to determine the impact of this problem and to better understand its risk factors.

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative; Knee Osteoarthritis; Prosthesis (Internal) Complications; Nocturnal Frequency

Detailed Description

In prosthetic knee surgery, there is a certain number of patients with post-operative nocturnal pain.

The purpose of our study is to determine the impact of this problem and to better understand its risk factors.

This is a poorly studied issue and the study could better detect, evaluate and treat painful patients after knee replacement surgery.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1200
    • Recruiting
    • Cliniques universitaires Saint-Luc
    • Contact: Jérémy Daxhelet, MD; Email: jeremy.daxhelet@uclouvain.be
    • Principal Investigator: Emmanuel Thienpont, MD, PhD

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult Patients undergoing elective primary Total knee arthroplasty or unicompartimental knee arthroplasty due to knee joint osteoarthritis coming to elective surgery at Cliniques universitaires Saint-Luc, Brussels

Description

Inclusion Criteria:

• Undergoing elective primary Total knee arthroplasty or unicompartmental knee arthroplasty due to knee joint osteoarthritis
• Older than 18 years
• Willing and able to complete pre and postoperative surveys

Exclusion Criteria:

• History of drug abuse
• Previous knee arthroplasty
• Mental disorders
• Rheumatoid arthritis
• Chronic renal disease
• Chronic hematological diseases (sickle cell disease, haemochromatosis...)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nocturnal pain	response to question (yes-no) "Does the pain in the operated knee wake you up at night or prevent you from sleeping?"	from day 1 of surgery until 1 year post surgery

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Emmanuel Thienpont, MD, PhD, Cliniques universitaires Saint-Luc

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2019
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): June 30, 2020

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2019
• Last Update Submitted That Met QC Criteria: July 10, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Lower Urinary Tract Symptoms; Urological Manifestations; Postoperative Complications; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Pain, Postoperative; Osteoarthritis, Knee; Nocturia
• Other Study ID Numbers: 2019/17AVR/182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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