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Oxycodone for Anterior Cruciate Ligament Rupture

Phase 4
Waitlist Available
Led By John Xerogeanes, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative days 0-6, 6 weeks post-surgery
Awards & highlights

Study Summary

This trial aimed to evaluate the effect of a multimodal pain management protocol, including the use of acetaminophen and celecoxib, on postoperative pain and opioid consumption in patients undergoing primary total knee arthroplasty.

Eligible Conditions
  • Anterior Cruciate Ligament Rupture

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative days 0-6, 6 weeks post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative days 0-6, 6 weeks post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pain Level: Numeric Rating Scale
Secondary outcome measures
Change in Pain catastrophizing scale (PCS)
Change in Pain threshold testing
Change in Quality of life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D
Other outcome measures
Change in Pain Catastrophizing Scale (PCS)
Change in Pain Threshold Testing
Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D

Side effects data

From 2022 Phase 4 trial • 393 Patients • NCT04122443
8%
Drowsiness
3%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ibuprofen and Then Acetaminophen (Stage 2)
Ibuprofen and Then Oxycodone/Acetaminophen (Stage 2)
Ibuprofen (Stage 1)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Oxycodone ArmExperimental Treatment1 Intervention
Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications. All participants will also receive the following as part of standard of care: Oral non-opioid (1000 mg acetaminophen), every 8 hours. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. Intraoperative education on post-surgical pain management.
Group II: Placebo ArmPlacebo Group1 Intervention
Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets. All participants will also receive the following as part of standard of care: Oral non-opioid (1000 mg acetaminophen), every 8 hours. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block. Intraoperative education on post-surgical pain management.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxycodone
2014
Completed Phase 4
~2210

Find a Location

Who is running the clinical trial?

Orthopedic Research and Education FoundationOTHER
19 Previous Clinical Trials
11,302 Total Patients Enrolled
Emory UniversityLead Sponsor
1,636 Previous Clinical Trials
2,560,475 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Rupture
50 Patients Enrolled for Anterior Cruciate Ligament Rupture
John Xerogeanes, MDPrincipal Investigator - Emory University
Emory University Hospital, Emory University Hospital Midtown
Emory University School Of Medicine (Medical School)
Children'S Hsp-Pittsburgh (Residency)
2 Previous Clinical Trials
165 Total Patients Enrolled
1 Trials studying Anterior Cruciate Ligament Rupture
50 Patients Enrolled for Anterior Cruciate Ligament Rupture

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Are Opioids Needed After ACL Reconstruction
John Xerogeanes 2020. "Are Opioids Needed After ACL Reconstruction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04285853.
~21 spots leftby Apr 2025
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