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NCT Number: NCT03858231

Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

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.

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Key information

Conditions

Knee Injuries Leg Injuries Neurologic Manifestations Opioid Use Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding, with the exception of ASA 81mg.
  • Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits.
  • Alcoholism

Treatment and study plan

Norco 5Mg-325Mg Tablet

Drug

1 tablet up to 4 times per day for 7 days

Ibuprofen 600 mg

Drug

1 tablet up to 4 times per day for 7 days

Acetaminophen 325Mg Tab

Drug

1 tablet up to 4 times per day for 7 days

Primary outcomes

  1. Change from Baseline Pain Assessment at 2 weeks

    Time frame: Daily for 2 weeks post-operatively

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

  2. Change from Baseline Medication Use at 2 weeks

    Time frame: Daily for 14 days post-operatively

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

Secondary outcomes

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

    Time frame: baseline, 2 weeks, and 6 weeks post-operatively

    Sub-scales are listed as follows: 5 qualitative questions related to knee symptoms ranging from "never" to "always", 2 qualitative questions related to knee stiffness ranging from "none" to "extreme", 9 qualitative questions related to pain ranging from "none" to "extreme", 17 qualitative questions related to function and daily living ranging from "none" to "extreme", 5 qualitative questions related to function and sports and recreational activities ranging from "none" to "extreme", and 4 qualitative questions related to quality of life ranging from "never or not at all" to "constantly, totally, or extreme".

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

    Time frame: baseline, 2 weeks, and 6 weeks post-operatively

    7 qualitative questions related to pain interference with responses ranging from "not at all" to "very much"

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Tuchscherer

CONTACT

[email protected]

(701) 417-6292

Katie Jensen

CONTACT

[email protected]

(605) 312-6983

Sponsors and collaborators

Lead sponsor

Sanford Health

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Feb 28, 2019
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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