NCT03858231

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P50-P75 for phase_4

Timeline
20mo left

Started Oct 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress82%
Oct 2018Jan 2028

Study Start

First participant enrolled

October 29, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

9.1 years

First QC Date

February 19, 2019

Last Update Submit

February 7, 2026

Conditions

Knee InjuriesPain, PostoperativeOpioid Use

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Pain Assessment at 2 weeks

    Visual Analog Scale from 0 to 10 with 0 being no pain and 10 being worst possible, unbearable, excruciating pain

    Daily for 2 weeks post-operatively

  • Change from Baseline Medication Use at 2 weeks

    Patients will be asked how many study medication capsules have they taken.

    Daily for 14 days post-operatively

Secondary Outcomes (2)

  • Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks

    baseline, 2 weeks, and 6 weeks post-operatively

  • Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks

    baseline, 2 weeks, and 6 weeks post-operatively

Study Arms (2)

Opioid

ACTIVE COMPARATOR
Drug: Norco 5Mg-325Mg Tablet

Non-opioid

ACTIVE COMPARATOR
Drug: Ibuprofen 600 mgDrug: Acetaminophen 325Mg Tab

Interventions

Norco 5Mg-325Mg TabletDRUG

1 tablet up to 4 times per day for 7 days

Opioid
Ibuprofen 600 mgDRUG

1 tablet up to 4 times per day for 7 days

Non-opioid
Acetaminophen 325Mg TabDRUG

1 tablet up to 4 times per day for 7 days

Non-opioid

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previously enrolled in this study (enrolled for contralateral knee in this study)
  • Knee arthroscopy patients scheduled for knee ligament reconstructions
  • Bilateral knee arthroscopy
  • History of chronic opioid use or long-term analgesic therapy
  • Documented or suspected substance abuse
  • Documented or suspected chronic pain syndrome
  • Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen
  • History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)
  • With active peptic ulcer disease (history of severe heartburn)
  • Symptoms of infection with initial enrollment
  • Pregnant or nursing
  • Diagnosis of cognitive impairment
  • Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study
  • 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.
  • Patient refusal
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanford Health

Fargo, North Dakota, 58122, United States

RECRUITING

MeSH Terms

Conditions

Knee InjuriesPain, Postoperative

Interventions

oxycodone-acetaminophenIbuprofenAcetaminophen

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsAcetanilidesAnilidesAmidesAniline CompoundsAmines

Study Officials

  • Bruce Piatt, MD

    Sanford Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Tuchscherer

CONTACT

(701) 417-6292amy.tuchscherer@sanfordhealth.org

Katie Jensen

CONTACT

(605) 312-6983Katie.E.Jensen@SanfordHealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 28, 2019

Study Start

October 29, 2018

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

January 1, 2028

Last Updated

February 10, 2026

Record last verified: 2026-02

Locations

US(1)