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N/A N=201 Randomized Single-blind Other

Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

Knee Injuries · ACL Injury

Enrolled (actual)
201
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Numeric Pain Rating Scale (NPRS) Pain Score — 5.2; 5.3; 5.0; 5.6 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Group 1-Knee Arthroscopy (Other); Group 2-Knee Arthroscopy (Other); Group 1-ACL reconstruction (Other); Group 2-ACL reconstruction (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Northwestern University
Primary completion
Mar 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Numeric Pain Rating Scale (NPRS) Pain Score
5.2; 5.3; 5.0; 5.6
PRIMARY
Opiate Count
3.5; 4.5; 9.5; 12.2
PRIMARY
Side Effects, 24 Hours Post-op
7; 5; 23; 24
PRIMARY
Numeric Pain Rating Scale (NPRS) Pain Scores
2.0; 2.4; 2.9; 2.6
PRIMARY
Opiate Count
3.5; 4.5; 9.5; 12.2
PRIMARY
Side Effects
7; 5; 24; 25
PRIMARY
Numeric Pain Rating Scale (NPRS) Pain Scores
2.0; 2.4; 2.9; 2.6
PRIMARY
Opiate Count
3.5; 4.5; 9.5; 12.2
PRIMARY
Number of Participants With Side Effects
7; 5; 24; 25
PRIMARY
Refill Requests
1; 0; 5; 7
PRIMARY
Still Taking Opiates?
3; 0; 5; 5; 45; 47
PRIMARY
Still Taking Opiates?
3; 0; 5; 5; 45; 47
PRIMARY
Still Taking Opiates?
3; 0; 5; 5; 45; 47
PRIMARY
Still Taking Opiates?
3; 0; 5; 5; 45; 47

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.

Eligibility Criteria

Inclusion Criteria

  • 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
  • 18 years old or greater
  • Ability to read and speak English

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03876743). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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