Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

Pain, Postoperative Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03858231
• Other study ID #: SH Opioid Knee
• Status: Recruiting
• Phase: Phase 4
• Start date: October 29, 2018
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Sanford Health
• Contact: Amy Tuchscherer
• Phone: (701) 417-6292
• Email: amy.tuchscherer[@]sanfordhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Injuries
• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Norco 5Mg-325Mg Tablet
1 tablet up to 4 times per day for 7 days
• Ibuprofen 600 mg
1 tablet up to 4 times per day for 7 days
• Acetaminophen 325Mg Tab
1 tablet up to 4 times per day for 7 days

Locations

Country	Name	City	State
United States	Sanford Health	Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Sanford Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change from Baseline Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks	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".	baseline, 2 weeks, and 6 weeks post-operatively
Secondary	Change from Baseline Patient Reported Outcome Measurement Information System (PROMIS) at 6 weeks	7 qualitative questions related to pain interference with responses ranging from "not at all" to "very much"	baseline, 2 weeks, and 6 weeks post-operatively