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Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

Primary Purpose

Knee Injuries, Pain, Postoperative, Opioid Use

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Norco 5Mg-325Mg Tablet

Ibuprofen 600 mg

Acetaminophen 325Mg Tab

About this trial

This is an interventional treatment trial for Knee Injuries

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
Currently on daily use of ibuprofen, acetaminophen or other pain altering medication, including medications like Neurontin (gabapentin) and Ultram (tramadol)
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
Patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits.
Alcoholism

Sites / Locations

Sanford HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Opioid

Non-opioid

Arm Description

Outcomes

Primary Outcome Measures

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

Change from Baseline Medication Use at 2 weeks

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

Secondary Outcome Measures

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".

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"

Full Information

NCT ID

NCT03858231

First Posted

February 19, 2019

Last Updated

June 14, 2023

Sponsor

Sanford Health

1. Study Identification

Unique Protocol Identification Number

NCT03858231

Brief Title

Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 29, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanford Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Knee Injuries, Pain, Postoperative, Opioid Use

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

148 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Opioid

Arm Type

Active Comparator

Arm Title

Non-opioid

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Norco 5Mg-325Mg Tablet

Intervention Description

1 tablet up to 4 times per day for 7 days

Intervention Type

Drug

Intervention Name(s)

Ibuprofen 600 mg

Intervention Description

1 tablet up to 4 times per day for 7 days

Intervention Type

Drug

Intervention Name(s)

Acetaminophen 325Mg Tab

Intervention Description

1 tablet up to 4 times per day for 7 days

Primary Outcome Measure Information:

Title

Change from Baseline Pain Assessment at 2 weeks

Description

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

Time Frame

Daily for 2 weeks post-operatively

Title

Change from Baseline Medication Use at 2 weeks

Description

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

Time Frame

Daily for 14 days post-operatively

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

baseline, 2 weeks, and 6 weeks post-operatively

Title

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

Description

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

Time Frame

baseline, 2 weeks, and 6 weeks post-operatively

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy Tuchscherer

Phone

(701) 417-6292

amy.tuchscherer@sanfordhealth.org

First Name & Middle Initial & Last Name or Official Title & Degree

Katie Jensen

Phone

(605) 312-6983

Katie.E.Jensen@SanfordHealth.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Piatt, MD

Organizational Affiliation

Sanford Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sanford Health

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58122

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kathy Mcevoy

Phone

701-417-6928

kathryn.mcevoy@sanfordhealth.org

First Name & Middle Initial & Last Name & Degree

Katie Jensen

Phone

(605) 312-6983

Katie.E.Jensen@SanfordHealth.org

First Name & Middle Initial & Last Name & Degree

Bruce Piatt, MD

12. IPD Sharing Statement

Learn more about this trial

Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery

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