Trial Outcomes & Findings for Opiates Prescribing for Knee Arthroscopies and ACL Reconstruction (NCT NCT03876743)
NCT ID: NCT03876743
Last Updated: 2020-10-14
Results Overview
2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
2 hours post-op
Results posted on
2020-10-14
Participant Flow
Participant milestones
| Measure |
Group 1 (Filled)-Knee Arthroscopy
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2 (as Needed)-Knee Arthroscopy
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: 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 1 (60)-ACL Reconstruction
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2(30)-ACL Reconstruction
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
51
|
46
|
50
|
|
Overall Study
COMPLETED
|
48
|
47
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
4
|
7
|
Reasons for withdrawal
| Measure |
Group 1 (Filled)-Knee Arthroscopy
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2 (as Needed)-Knee Arthroscopy
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: 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 1 (60)-ACL Reconstruction
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2(30)-ACL Reconstruction
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
4
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 (Filled)-Knee Arthroscopy
n=54 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2 (as Needed)-Knee Arthroscopy
n=51 Participants
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: 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 1 (60)-ACL Reconstruction
n=46 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30)-ACL Reconstruction
n=50 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Total
n=201 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=54 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=201 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=54 Participants
|
51 Participants
n=51 Participants
|
46 Participants
n=46 Participants
|
50 Participants
n=50 Participants
|
200 Participants
n=201 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=54 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=50 Participants
|
1 Participants
n=201 Participants
|
|
Age, Continuous
|
43.8 Years
STANDARD_DEVIATION 12.5 • n=54 Participants
|
43.2 Years
STANDARD_DEVIATION 13.2 • n=51 Participants
|
33.2 Years
STANDARD_DEVIATION 8.9 • n=46 Participants
|
31.3 Years
STANDARD_DEVIATION 10.0 • n=50 Participants
|
38.1 Years
STANDARD_DEVIATION 12.6 • n=201 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=54 Participants
|
20 Participants
n=51 Participants
|
22 Participants
n=46 Participants
|
23 Participants
n=50 Participants
|
96 Participants
n=201 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=54 Participants
|
31 Participants
n=51 Participants
|
24 Participants
n=46 Participants
|
27 Participants
n=50 Participants
|
105 Participants
n=201 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
29.2 kg/m^2
STANDARD_DEVIATION 7.6 • n=54 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 7.9 • n=51 Participants
|
26.4 kg/m^2
STANDARD_DEVIATION 4.1 • n=46 Participants
|
28.1 kg/m^2
STANDARD_DEVIATION 6.0 • n=50 Participants
|
28.4 kg/m^2
STANDARD_DEVIATION 6.7 • n=201 Participants
|
|
Are you an active smoker?
Yes
|
5 Participants
n=54 Participants
|
7 Participants
n=51 Participants
|
1 Participants
n=46 Participants
|
4 Participants
n=50 Participants
|
17 Participants
n=201 Participants
|
|
Are you an active smoker?
No
|
49 Participants
n=54 Participants
|
44 Participants
n=51 Participants
|
45 Participants
n=46 Participants
|
46 Participants
n=50 Participants
|
184 Participants
n=201 Participants
|
|
If no, have you ever consistently smoked cigarettes (daily for >1 month)?
Yes
|
2 Participants
n=49 Participants • Among participants who are not current smokers
|
7 Participants
n=44 Participants • Among participants who are not current smokers
|
4 Participants
n=45 Participants • Among participants who are not current smokers
|
2 Participants
n=46 Participants • Among participants who are not current smokers
|
15 Participants
n=184 Participants • Among participants who are not current smokers
|
|
If no, have you ever consistently smoked cigarettes (daily for >1 month)?
No
|
47 Participants
n=49 Participants • Among participants who are not current smokers
|
37 Participants
n=44 Participants • Among participants who are not current smokers
|
41 Participants
n=45 Participants • Among participants who are not current smokers
|
44 Participants
n=46 Participants • Among participants who are not current smokers
|
169 Participants
n=184 Participants • Among participants who are not current smokers
|
|
What is your employment status?
Employed
|
48 Participants
n=54 Participants
|
40 Participants
n=51 Participants
|
39 Participants
n=46 Participants
|
36 Participants
n=50 Participants
|
163 Participants
n=201 Participants
|
|
What is your employment status?
Unemployed
|
2 Participants
n=54 Participants
|
6 Participants
n=51 Participants
|
6 Participants
n=46 Participants
|
12 Participants
n=50 Participants
|
26 Participants
n=201 Participants
|
|
What is your employment status?
Disabled
|
1 Participants
n=54 Participants
|
2 Participants
n=51 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=50 Participants
|
4 Participants
n=201 Participants
|
|
What is your employment status?
Retired
|
3 Participants
n=54 Participants
|
3 Participants
n=51 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=50 Participants
|
8 Participants
n=201 Participants
|
|
Is this injury part of a workers compensation claim?
Yes
|
0 Participants
n=54 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=46 Participants
|
1 Participants
n=50 Participants
|
3 Participants
n=201 Participants
|
|
Is this injury part of a workers compensation claim?
No
|
54 Participants
n=54 Participants
|
50 Participants
n=51 Participants
|
45 Participants
n=46 Participants
|
49 Participants
n=50 Participants
|
198 Participants
n=201 Participants
|
|
Are you actively participating in sporting activities?
Yes
|
14 Participants
n=54 Participants
|
16 Participants
n=51 Participants
|
26 Participants
n=46 Participants
|
32 Participants
n=50 Participants
|
88 Participants
n=201 Participants
|
|
Are you actively participating in sporting activities?
No
|
40 Participants
n=54 Participants
|
35 Participants
n=51 Participants
|
20 Participants
n=46 Participants
|
18 Participants
n=50 Participants
|
113 Participants
n=201 Participants
|
|
At what level (i.e. professional, collegiate, recreational)?
Professional
|
0 Participants
n=54 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=46 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=201 Participants
|
|
At what level (i.e. professional, collegiate, recreational)?
Collegiate
|
2 Participants
n=54 Participants
|
3 Participants
n=51 Participants
|
3 Participants
n=46 Participants
|
2 Participants
n=50 Participants
|
10 Participants
n=201 Participants
|
|
At what level (i.e. professional, collegiate, recreational)?
Recreational
|
12 Participants
n=54 Participants
|
13 Participants
n=51 Participants
|
25 Participants
n=46 Participants
|
29 Participants
n=50 Participants
|
79 Participants
n=201 Participants
|
|
At what level (i.e. professional, collegiate, recreational)?
N/A
|
40 Participants
n=54 Participants
|
35 Participants
n=51 Participants
|
18 Participants
n=46 Participants
|
17 Participants
n=50 Participants
|
110 Participants
n=201 Participants
|
|
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/Oxycodone) ?
Yes
|
0 Participants
n=54 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=201 Participants
|
|
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/Oxycodone) ?
No
|
54 Participants
n=54 Participants
|
51 Participants
n=51 Participants
|
46 Participants
n=46 Participants
|
50 Participants
n=50 Participants
|
201 Participants
n=201 Participants
|
|
Do you have a personal history of illicit substance abuse?
Yes
|
0 Participants
n=54 Participants
|
0 Participants
n=51 Participants
|
0 Participants
n=46 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=201 Participants
|
|
Do you have a personal history of illicit substance abuse?
No
|
54 Participants
n=54 Participants
|
51 Participants
n=51 Participants
|
46 Participants
n=46 Participants
|
50 Participants
n=50 Participants
|
201 Participants
n=201 Participants
|
|
Do you have a family history of illicit substance abuse?
Yes
|
4 Participants
n=54 Participants
|
4 Participants
n=51 Participants
|
7 Participants
n=46 Participants
|
6 Participants
n=50 Participants
|
21 Participants
n=201 Participants
|
|
Do you have a family history of illicit substance abuse?
No
|
50 Participants
n=54 Participants
|
47 Participants
n=51 Participants
|
39 Participants
n=46 Participants
|
44 Participants
n=50 Participants
|
180 Participants
n=201 Participants
|
|
What is the highest level of education you have attained?
Completed High School
|
12 Participants
n=54 Participants
|
7 Participants
n=51 Participants
|
6 Participants
n=46 Participants
|
11 Participants
n=50 Participants
|
36 Participants
n=201 Participants
|
|
What is the highest level of education you have attained?
Undergraduate
|
25 Participants
n=54 Participants
|
26 Participants
n=51 Participants
|
24 Participants
n=46 Participants
|
29 Participants
n=50 Participants
|
104 Participants
n=201 Participants
|
|
What is the highest level of education you have attained?
Graduate
|
17 Participants
n=54 Participants
|
18 Participants
n=51 Participants
|
16 Participants
n=46 Participants
|
10 Participants
n=50 Participants
|
61 Participants
n=201 Participants
|
|
What is your average yearly household income?
Less than $20,000
|
2 Participants
n=54 Participants
|
6 Participants
n=51 Participants
|
4 Participants
n=46 Participants
|
4 Participants
n=50 Participants
|
16 Participants
n=201 Participants
|
|
What is your average yearly household income?
$20,000 -$34,999
|
3 Participants
n=54 Participants
|
1 Participants
n=51 Participants
|
1 Participants
n=46 Participants
|
2 Participants
n=50 Participants
|
7 Participants
n=201 Participants
|
|
What is your average yearly household income?
$35,000 -$49,999
|
10 Participants
n=54 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=46 Participants
|
8 Participants
n=50 Participants
|
26 Participants
n=201 Participants
|
|
What is your average yearly household income?
$50,000 -$74,999
|
8 Participants
n=54 Participants
|
10 Participants
n=51 Participants
|
11 Participants
n=46 Participants
|
13 Participants
n=50 Participants
|
42 Participants
n=201 Participants
|
|
What is your average yearly household income?
$75,000 - $99,999
|
8 Participants
n=54 Participants
|
8 Participants
n=51 Participants
|
7 Participants
n=46 Participants
|
9 Participants
n=50 Participants
|
32 Participants
n=201 Participants
|
|
What is your average yearly household income?
$100,000 -$149,999
|
4 Participants
n=54 Participants
|
11 Participants
n=51 Participants
|
8 Participants
n=46 Participants
|
8 Participants
n=50 Participants
|
31 Participants
n=201 Participants
|
|
What is your average yearly household income?
$150,000 - $199,999
|
9 Participants
n=54 Participants
|
1 Participants
n=51 Participants
|
3 Participants
n=46 Participants
|
2 Participants
n=50 Participants
|
15 Participants
n=201 Participants
|
|
What is your average yearly household income?
$200,000 or more
|
10 Participants
n=54 Participants
|
10 Participants
n=51 Participants
|
8 Participants
n=46 Participants
|
4 Participants
n=50 Participants
|
32 Participants
n=201 Participants
|
PRIMARY outcome
Timeframe: 2 hours post-op2 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Score
|
5.2 score on a scale
Standard Deviation 1.8
|
5.3 score on a scale
Standard Deviation 2.2
|
5.0 score on a scale
Standard Deviation 2.7
|
5.6 score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 24 hours post-op24 hours post-op
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Opiate Count
|
1.4 pills
Standard Deviation 1.8
|
1.6 pills
Standard Deviation 1.6
|
2.5 pills
Standard Deviation 2.2
|
3.6 pills
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: 24 hours post-opNumber of Participants with Side Effects, 24 hours post-op
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Side Effects, 24 Hours Post-op
|
7 Participants
|
5 Participants
|
23 Participants
|
24 Participants
|
PRIMARY outcome
Timeframe: 48 hours post-op48 hours post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
3.0 score on a scale
Standard Deviation 2.1
|
3.5 score on a scale
Standard Deviation .4
|
4.2 score on a scale
Standard Deviation 2.2
|
4.6 score on a scale
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 48 hours post-op48 hours post-op
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Opiate Count
|
2.1 pills
Standard Deviation 2.8
|
2.5 pills
Standard Deviation 2.8
|
4.8 pills
Standard Deviation 4.4
|
6.0 pills
Standard Deviation 3.9
|
PRIMARY outcome
Timeframe: 48 hours post-op48 hours post-op
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Side Effects
|
7 Participants
|
5 Participants
|
24 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: 7 days post-op7 days post-op; minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value is better
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
2.0 score on a scale
Standard Deviation 1.8
|
2.4 score on a scale
Standard Deviation 2.3
|
2.9 score on a scale
Standard Deviation 2.0
|
2.6 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 7 days post-opNumber Pills Taken
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Opiate Count
|
3.5 Pills Hydrocodone/Acetaminophen 10/325mg
Standard Deviation 6.3
|
4.5 Pills Hydrocodone/Acetaminophen 10/325mg
Standard Deviation 6.0
|
9.5 Pills Hydrocodone/Acetaminophen 10/325mg
Standard Deviation 10.0
|
12.2 Pills Hydrocodone/Acetaminophen 10/325mg
Standard Deviation 14.2
|
PRIMARY outcome
Timeframe: 7 days post-opPotential side effects included lightheadedness, nausea, drowsiness, gastrointestinal symptoms, constipation
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Number of Participants With Side Effects
|
7 Participants
|
5 Participants
|
24 Participants
|
25 Participants
|
PRIMARY outcome
Timeframe: Within 3 months after surgeryNumber of participants requesting opioid refills within 3 months after surgery
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Refill Requests
|
1 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 1 day postoperativeNumber of patients who took any opiates between surgery and 1 day postoperative
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Still Taking Opiates?
Yes
|
38 Participants
|
30 Participants
|
38 Participants
|
39 Participants
|
|
Still Taking Opiates?
No
|
10 Participants
|
17 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 2 days postoperativeNumber of patients who took any opiates between 1 day and 2 days postoperative
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Still Taking Opiates?
Yes
|
25 Participants
|
19 Participants
|
33 Participants
|
33 Participants
|
|
Still Taking Opiates?
No
|
23 Participants
|
28 Participants
|
10 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 7 days postoperativelyNumber of patients who took any opiates between 2 days and 7 days postoperative
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Still Taking Opiates?
Yes
|
18 Participants
|
17 Participants
|
29 Participants
|
31 Participants
|
|
Still Taking Opiates?
No
|
30 Participants
|
30 Participants
|
14 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: 21 days postoperativelyNumber of patients who took any opiates between 7 days and 21 days postoperative
Outcome measures
| Measure |
Group 1-Knee Arthroscopy
n=48 Participants
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: Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
|
Group 2-Knee Arthroscopy
n=47 Participants
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: 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 1-ACL Reconstruction
n=43 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1-ACL reconstruction: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2-ACL Reconstruction
n=42 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2-ACL reconstruction: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|---|---|
|
Still Taking Opiates?
Yes
|
3 Participants
|
0 Participants
|
5 Participants
|
5 Participants
|
|
Still Taking Opiates?
No
|
45 Participants
|
47 Participants
|
38 Participants
|
37 Participants
|
Adverse Events
Group 1-Knee Arthroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2-Knee Arthroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 1-ACL Reconstruction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2-ACL Reconstruction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melissa Shauver; Research Project Manager
Northwestern University
Phone: 3124726024
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place