NCT03876743

Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction

Completed NA Results posted Last updated 14 October 2020

What this trial tests

NA trial testing Group 1-Knee Arthroscopy in Knee Injuries in 201 participants. Completed in 8 July 2020.

Timeline

26 March 2018

Primary endpoint
23 March 2020

8 July 2020

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	201
Start date	26 March 2018
Primary completion	23 March 2020
Estimated completion	8 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Group 1-Knee Arthroscopy
• Group 2-Knee Arthroscopy
• Group 1-ACL reconstruction
• Group 2-ACL reconstruction

Conditions studied

• Knee Injuries — all drugs for Knee Injuries →
• ACL Injury — all drugs for ACL Injury →

Sponsor

Northwestern University

Who can join

Adults 18 to 89, any sex, with Knee Injuries or ACL Injury. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numeric Pain Rating Scale (NPRS) Pain Score Primary · 2 hours post-op

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

Group	Value	95% CI
Group 1-Knee Arthroscopy	5.2	± 1.8
Group 2-Knee Arthroscopy	5.3	± 2.2
Group 1-ACL Reconstruction	5.0	± 2.7
Group 2-ACL Reconstruction	5.6	± 2.2

Opiate Count Primary · 24 hours post-op

24 hours post-op

Group	Value	95% CI
Group 1-Knee Arthroscopy	1.4	± 1.8
Group 2-Knee Arthroscopy	1.6	± 1.6
Group 1-ACL Reconstruction	2.5	± 2.2
Group 2-ACL Reconstruction	3.6	± 2.4

Side Effects, 24 Hours Post-op Primary · 24 hours post-op

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

Group	Value	95% CI
Group 1-Knee Arthroscopy	7
Group 2-Knee Arthroscopy	5
Group 1-ACL Reconstruction	23
Group 2-ACL Reconstruction	24

Numeric Pain Rating Scale (NPRS) Pain Scores Primary · 48 hours post-op

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

Group	Value	95% CI
Group 1-Knee Arthroscopy	3.0	± 2.1
Group 2-Knee Arthroscopy	3.5	± .4
Group 1-ACL Reconstruction	4.2	± 2.2
Group 2-ACL Reconstruction	4.6	± 2.2

Opiate Count Primary · 48 hours post-op

48 hours post-op

Group	Value	95% CI
Group 1-Knee Arthroscopy	2.1	± 2.8
Group 2-Knee Arthroscopy	2.5	± 2.8
Group 1-ACL Reconstruction	4.8	± 4.4
Group 2-ACL Reconstruction	6.0	± 3.9

Side Effects Primary · 48 hours post-op

48 hours post-op

Group	Value	95% CI
Group 1-Knee Arthroscopy	7
Group 2-Knee Arthroscopy	5
Group 1-ACL Reconstruction	24
Group 2-ACL Reconstruction	25

Numeric Pain Rating Scale (NPRS) Pain Scores Primary · 7 days post-op

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

Group	Value	95% CI
Group 1-Knee Arthroscopy	2.0	± 1.8
Group 2-Knee Arthroscopy	2.4	± 2.3
Group 1-ACL Reconstruction	2.9	± 2.0
Group 2-ACL Reconstruction	2.6	± 1.8

Opiate Count Primary · 7 days post-op

Number Pills Taken

Group	Value	95% CI
Group 1-Knee Arthroscopy	3.5	± 6.3
Group 2-Knee Arthroscopy	4.5	± 6.0
Group 1-ACL Reconstruction	9.5	± 10.0
Group 2-ACL Reconstruction	12.2	± 14.2

Number of Participants With Side Effects Primary · 7 days post-op

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

Group	Value	95% CI
Group 1-Knee Arthroscopy	7
Group 2-Knee Arthroscopy	5
Group 1-ACL Reconstruction	24
Group 2-ACL Reconstruction	25

Refill Requests Primary · Within 3 months after surgery

Number of participants requesting opioid refills within 3 months after surgery

Group	Value	95% CI
Group 1-Knee Arthroscopy	1
Group 2-Knee Arthroscopy	0
Group 1-ACL Reconstruction	5
Group 2-ACL Reconstruction	7

Still Taking Opiates? Primary · 1 day postoperative

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

Group	Value	95% CI
Group 1 (Filled)-Knee Arthroscopy	38
Group 2 (as Needed)-Knee Arthroscopy	30
Group 1 (60)-ACL Reconstruction	38
Group 2(30)-ACL Reconstruction	39
Group 1 (Filled)-Knee Arthroscopy	10
Group 2 (as Needed)-Knee Arthroscopy	17
Group 1 (60)-ACL Reconstruction	5
Group 2(30)-ACL Reconstruction	3

Still Taking Opiates? Primary · 2 days postoperative

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

Group	Value	95% CI
Group 1 (Filled)-Knee Arthroscopy	25
Group 2 (as Needed)-Knee Arthroscopy	19
Group 1 (60)-ACL Reconstruction	33
Group 2(30)-ACL Reconstruction	33
Group 1 (Filled)-Knee Arthroscopy	23
Group 2 (as Needed)-Knee Arthroscopy	28
Group 1 (60)-ACL Reconstruction	10
Group 2(30)-ACL Reconstruction	9

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Can We Eliminate Opioid Medications for Postoperative Pain Control? A Prospective, Surgeon-Blinded, Randomized Controlled Trial in Knee Arthroscopic Surgery.
   Hartwell MJ, Selley RS, Terry MA, Tjong VK. · · 2020 · cited 17× · PMID 32755488 · DOI 10.1177/0363546520941861
2. Reduced Opioid Prescription After Anterior Cruciate Ligament Reconstruction Does Not Affect Postoperative Pain or Prescription Refills: A Prospective, Surgeon-Blinded, Randomized, Controlled Trial.
   Hartwell MJ, Selley RS, Alvandi BA, Dayton SR, et al · · 2021 · cited 9× · PMID 34195628 · DOI 10.1016/j.asmr.2020.12.012