NCT03876743

Brief Summary

The purpose of the study is to determine if opiates are required to achieve adequate analgesia after knee arthroscopy and ACL reconstruction in outpatient surgery. The investigators hypothesize that patients are frequently prescribed more opiates than are needed after surgery, resulting in excess medications that are at risk for misuse, diversion and contribution to the opioid epidemic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 20, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

March 26, 2018

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed
Last Updated

October 14, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

March 20, 2018

Results QC Date

July 29, 2020

Last Update Submit

September 18, 2020

Conditions

Knee InjuriesACL Injury

Outcome Measures

Primary Outcomes (14)

  • Numeric Pain Rating Scale (NPRS) Pain Score

    2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better

    2 hours post-op

  • Opiate Count

    24 hours post-op

    24 hours post-op

  • Side Effects, 24 Hours Post-op

    Number of Participants with Side Effects, 24 hours post-op

    24 hours post-op

  • Numeric Pain Rating Scale (NPRS) Pain Scores

    48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better

    48 hours post-op

  • Opiate Count

    48 hours post-op

    48 hours post-op

  • Side Effects

    48 hours post-op

    48 hours post-op

  • Numeric Pain Rating Scale (NPRS) Pain Scores

    7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better

    7 days post-op

  • Opiate Count

    Number Pills Taken

    7 days post-op

  • Number of Participants With Side Effects

    Potential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation

    7 days post-op

  • Refill Requests

    Number of participants requesting opioid refills within 3 months after surgery

    Within 3 months after surgery

  • Still Taking Opiates?

    Number of patients who took any opiates between surgery and 1 day postoperative

    1 day postoperative

  • Still Taking Opiates?

    Number of patients who took any opiates between 1 day and 2 days postoperative

    2 days postoperative

  • Still Taking Opiates?

    Number of patients who took any opiates between 2 days and 7 days postoperative

    7 days postoperatively

  • Still Taking Opiates?

    Number of patients who took any opiates between 7 days and 21 days postoperative

    21 days postoperatively

Study Arms (4)

Group 1-Knee Arthroscopy

EXPERIMENTAL

Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.

Other: Group 1-Knee Arthroscopy

Group 2-Knee Arthroscopy

EXPERIMENTAL

Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.

Other: Group 2-Knee Arthroscopy

Group 1-ACL reconstruction

EXPERIMENTAL

Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.

Other: Group 1-ACL reconstruction

Group 2-ACL reconstruction

EXPERIMENTAL

Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.

Other: Group 2-ACL reconstruction

Interventions

Group 1-Knee ArthroscopyOTHER

Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.

Group 1-Knee Arthroscopy
Group 2-Knee ArthroscopyOTHER

Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.

Group 2-Knee Arthroscopy
Group 1-ACL reconstructionOTHER

Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.

Group 1-ACL reconstruction
Group 2-ACL reconstructionOTHER

Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.

Group 2-ACL reconstruction

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients presenting to Northwestern Memorial Hospital (NMH) or to a Northwestern orthopaedic surgery faculty member's clinic undergoing knee arthroscopy with meniscus repair and/or debridement
  • years old or greater
  • Ability to read and speak English

You may not qualify if:

  • Revision surgery
  • Oncologic surgery
  • Arthroscopic knee surgery that involves procedures other than ACL or the meniscus (i.e PCL, LCL, MPFL)
  • Patients currently taking narcotics, chronic pain management patients, history of substance abuse
  • Adults unable to consent
  • Individuals who are not yet adults (infants, children, teenagers)
  • Pregnant women
  • Prisoners
  • Patients currently taking narcotics, chronic pain management patients, history of substance abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern Medicine Department of Orthopaedic Surgery

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Hartwell MJ, Selley RS, Terry MA, Tjong VK. Can We Eliminate Opioid Medications for Postoperative Pain Control? A Prospective, Surgeon-Blinded, Randomized Controlled Trial in Knee Arthroscopic Surgery. Am J Sports Med. 2020 Sep;48(11):2711-2717. doi: 10.1177/0363546520941861. Epub 2020 Aug 5.

    PMID: 32755488DERIVED

MeSH Terms

Conditions

Knee InjuriesAnterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Results Point of Contact

Title
Melissa Shauver; Research Project Manager
Organization
Northwestern University
melissa.shauver1@nm.org
3124726024

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 20, 2018

First Posted

March 15, 2019

Study Start

March 26, 2018

Primary Completion

March 23, 2020

Study Completion

July 8, 2020

Last Updated

October 14, 2020

Results First Posted

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)