RECRUITING

Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

Conditions

Knee Injuries Pain, Postoperative Opioid Use

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy. This study will determine 1) whether the most commonly used non-narcotic medications provide pain relief comparable with the most commonly prescribed narcotic medications in patients undergoing arthroscopic knee surgery, and 2) whether patients' characteristics (gender, pre-operative knee symptoms, workers compensation status and employment status) affect pain level following surgery or medication usage.

Official Title

The Effects of Combination Therapy of Opioids Versus Non-Opioids on Postoperative Pain Management After Knee Arthroscopic Surgery: A Prospective Randomized Controlled Study

Quick Facts

Study Start:2018-10-29

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03858231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Subjects ≥ 18 years of age through ≤ 80 years of age 2. Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal.	1. Previously enrolled in this study (enrolled for contralateral knee in this study) 2. Knee arthroscopy patients scheduled for knee ligament reconstructions 3. Bilateral knee arthroscopy 4. History of chronic opioid use or long-term analgesic therapy 5. Documented or suspected substance abuse 6. Documented or suspected chronic pain syndrome 7. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen 8. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease) 9. With active peptic ulcer disease (history of severe heartburn) 10. Symptoms of infection with initial enrollment 11. Pregnant or nursing 12. Diagnosis of cognitive impairment 13. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study 14. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by Institutional Review Board) and agree to abide by the study restrictions. 15. Patient refusal 16. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding, with the exception of ASA 81mg. 17. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits. 18. Alcoholism

Inclusion Criteria

Exclusion Criteria

1. Subjects ≥ 18 years of age through ≤ 80 years of age
2. Subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal.

1. Previously enrolled in this study (enrolled for contralateral knee in this study)
2. Knee arthroscopy patients scheduled for knee ligament reconstructions
3. Bilateral knee arthroscopy
4. History of chronic opioid use or long-term analgesic therapy
5. Documented or suspected substance abuse
6. Documented or suspected chronic pain syndrome
7. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen
8. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
9. With active peptic ulcer disease (history of severe heartburn)
10. Symptoms of infection with initial enrollment
11. Pregnant or nursing
12. Diagnosis of cognitive impairment
13. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study
14. Inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by Institutional Review Board) and agree to abide by the study restrictions.
15. Patient refusal
16. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding, with the exception of ASA 81mg.
17. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits.
18. Alcoholism

Contacts and Locations

Study Contact

Amy Tuchscherer

CONTACT

(701) 417-6292

amy.tuchscherer@sanfordhealth.org

Katie Jensen

CONTACT

(605) 312-6983

Katie.E.Jensen@SanfordHealth.org

Principal Investigator

Bruce Piatt, MD

PRINCIPAL_INVESTIGATOR

Sanford Health

Study Locations (Sites)

Sanford Health

Fargo, North Dakota, 58122

United States

Collaborators and Investigators

Sponsor: Sanford Health

Bruce Piatt, MD, PRINCIPAL_INVESTIGATOR, Sanford Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-10-29

Study Completion Date2026-01

Study Record Updates

Study Start Date2018-10-29

Study Completion Date2026-01

Terms related to this study

Additional Relevant MeSH Terms

Knee Injuries
Pain, Postoperative
Opioid Use