Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

• Sponsor: Sanford Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03858231
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 62.1
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Injuries; Pain, Postoperative; Opioid Use	Drug: Norco 5Mg-325Mg Tablet; Drug: Ibuprofen 600 mg; Drug: Acetaminophen 325Mg Tab	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Oct 29, 2018
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Opioid	Drug: Norco 5Mg-325Mg Tablet; 1 tablet up to 4 times per day for 7 days
Active Comparator: Non-opioid	Drug: Ibuprofen 600 mg; 1 tablet up to 4 times per day for 7 days; Drug: Acetaminophen 325Mg Tab; 1 tablet up to 4 times per day for 7 days

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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".

2. 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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. Currently on daily use of ibuprofen, acetaminophen or other pain altering medication, including medications like Neurontin (gabapentin) and Ultram (tramadol)

7. Documented or suspected chronic pain syndrome

8. Any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen

9. History or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease)

10. With active peptic ulcer disease (history of severe heartburn)

11. Symptoms of infection with initial enrollment

12. Pregnant or nursing

13. Diagnosis of cognitive impairment

14. Unable or unwilling to provide informed consent for surgery or enrollment in this clinical study

15. 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.

16. Patient refusal

17. Currently taking Coumadin, Plavix, anticoagulation medications, or medications that increase bleeding

18. Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits.

19. Alcoholism

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanford Health	Fargo	North Dakota	United States	58122

Sponsors and Collaborators

• Sanford Health

Investigators

• Principal Investigator: Bruce Piatt, MD, Sanford Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanford Health
• ClinicalTrials.gov Identifier: NCT03858231
• Other Study ID Numbers: SH Opioid Knee
• First Posted: Feb 28, 2019
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Pain, Postoperative; Knee Injuries; Acetaminophen; Ibuprofen

Study Results

No Results Posted as of Apr 14, 2022