Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

Phase 4

Recruiting

• Conditions: Knee Injuries; Pain, Postoperative; Opioid Use
• Interventions: Drug: Norco 5Mg-325Mg Tablet; Drug: Ibuprofen 600 mg; Drug: Acetaminophen 325Mg Tab

• Registration Number: NCT03858231
• Lead Sponsor: Sanford Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-29
• Study First Submitted: 2019-02-19
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-22
• Last Update Posted: 2024-02-26
• Primary Completion: 2025-12
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Opioid	Norco 5Mg-325Mg Tablet	-
Non-opioid	Acetaminophen 325Mg Tab	-
Non-opioid	Ibuprofen 600 mg	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Pain Assessment at 2 weeks	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
Change from Baseline Medication Use at 2 weeks	Daily for 14 days post-operatively	Patients will be asked how many study medication capsules have they taken.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks	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"
Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks	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".

Trial Locations

Locations (1)

Sanford Health; 🇺🇸 Fargo, North Dakota, United States