Pain Profile and Pain Medication Use After THA and TKA

NCT03714711 | Withdrawn DMC

• 1 other identifier: Pro00100351
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The over-prescription and overuse of opioid medications in the United States has recently been recognized as an epidemic. A new law in North Carolina (STOP Act) is aimed to limit opioid prescriptions following any surgical procedure including total hip (THA) and total knee arthroplasty (TKA). However, there is limited evidence regarding patient's pain and actual opioid consumption following THA and TKA that can be used by practitioners as guidance adapting to the new law. The purpose of this study is to investigate patient's pain and pain medication use in the perioperative period (0-6 weeks) following THA and TKA to establish a pain profile and thereby investigating risk factor for increased postoperative pain and opioid pain medication requirements. This study aims to stratify a predication model of postoperative pain and opioid medication requirement after THA and TKA to identify patients with a high propensity for pain, improve preoperative patient education on postoperative pain expectations, thereby helping practitioners implement new postoperative prescriptions limits for THA and TKA patient.

Conditions

Pain, Postoperative

Keywords

total hip replacement; total knee replacement

Outcome Measures

Primary Outcomes (1)

• Change in Patient Pain level

  Change in Patients' pain level on visual analog scale from 0-10; 0 no pain, 10 worst pain imaginable

  1 - 6 weeks on average

Secondary Outcomes (12)

• Change in opioid consumption

  daily for 6 weeks after surgery

• Change in satisfaction level

  daily for 6 weeks after surgery

• EQ5D

  Once before surgery, up to 10 minutes

• EQ5D

  6 weeks postoperative

• EQ5D

  1 year postoperative

Study Arms (2)

Total hip arthroplasty

Patient who are scheduled to undergo total hip replacement.

Procedure: total hip arthroplasty

Total knee arthroplasty

Patient who are scheduled to undergo total knee replacement.

Procedure: total knee arthroplasty

Interventions

total hip arthroplasty PROCEDURE

Total hip replacement

Total hip arthroplasty

total knee arthroplasty PROCEDURE

Total knee replacement

Total knee arthroplasty

Eligibility Criteria

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

Study Population

Patients undergoing primary total hip or knee arthroplasty

You may qualify if:

• Patients older than 18 years of age undergoing primary total hip or total knee replacement
• Able to give consent to participate in the study
• Patients have a cell phone capable of text messaging

You may not qualify if:

• Patients from states in the US without a narcotic prescription database (Missouri)
• Patients with previous joint surgery

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Arthroplasty, Replacement, Hip; Arthroplasty, Replacement, Knee

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Thorsten Seyler, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: October 22, 2018
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share