NCT04278703

Brief Summary

The purpose of this study is to evaluate the effectiveness of a post-operative opioid pain 18 management protocol for anterior cruciate ligament reconstruction (ACLR).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

February 18, 2020

Last Update Submit

February 18, 2020

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • Post-operative pain

    Post-operative pain as reported by patients on a 0-10 VAS pain scale. 0 is no pain and 10 is worst pain imaginable

    14 days post-operative

Study Arms (3)

15 opioid tablets perscribed

ACTIVE COMPARATOR

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

Drug: Oxycodone

25 opioid tablets perscribed

ACTIVE COMPARATOR

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

Drug: Oxycodone

35 opioid tablets perscribed

ACTIVE COMPARATOR

For this treatment arm, patients will be given a prescription of 15 tablets of Oxycodone which they may take to alleviate post-operative pain

Drug: oxycodone

Interventions

oxycodoneDRUG

Patients will be given a prescription for 15 opioid tablets for post-operative pain

15 opioid tablets perscribed

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- All patients undergoing primary ACLR for ACL tear, including patients with concomitant 76 meniscectomy or meniscal repair.

You may not qualify if:

  • Concomitant procedure other than meniscectomy or meniscal repair.
  • ACL revision
  • History of chronic pre-operative opioid use
  • History of substance abuse
  • Workmen's compensation claims
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Orthopaedics at Egg Harbor Township

Egg Harbor, New Jersey, 08234, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

CodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2020

First Posted

February 20, 2020

Study Start

February 15, 2019

Primary Completion

January 1, 2021

Study Completion

March 1, 2021

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations

US(1)