Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

NCT ID: NCT03858231

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-29

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Injuries Pain, Postoperative Opioid Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Opioid

Group Type ACTIVE_COMPARATOR

Norco 5Mg-325Mg Tablet

Intervention Type DRUG

1 tablet up to 4 times per day for 7 days

Non-opioid

Group Type ACTIVE_COMPARATOR

Ibuprofen 600 mg

Intervention Type DRUG

1 tablet up to 4 times per day for 7 days

Acetaminophen 325Mg Tab

Intervention Type DRUG

1 tablet up to 4 times per day for 7 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Norco 5Mg-325Mg Tablet

1 tablet up to 4 times per day for 7 days

Intervention Type DRUG

Ibuprofen 600 mg

1 tablet up to 4 times per day for 7 days

Intervention Type DRUG

Acetaminophen 325Mg Tab

1 tablet up to 4 times per day for 7 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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.

Exclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanford Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bruce Piatt, MD

Role: PRINCIPAL_INVESTIGATOR

Sanford Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sanford Health

Fargo, North Dakota, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amy Tuchscherer

Role: CONTACT

(701) 417-6292

Katie Jensen

Role: CONTACT

(605) 312-6983

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kathy Mcevoy

Role: primary

701-417-6928

Katie Jensen

Role: backup

(605) 312-6983

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SH Opioid Knee

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

NSAID vs. Narcotics
NCT02915055 COMPLETED
Acute Pain and Inflammation After Surgery
NCT00774540 COMPLETED PHASE4
CBD Knee Scope Study
NCT05934500 NOT_YET_RECRUITING EARLY_PHASE1
Dronabinol After Arthroscopic Surgery
NCT05335252 RECRUITING PHASE3
Post-operative Efficacy and Safety Study
NCT00904085 COMPLETED PHASE3