Trial Outcomes & Findings for Opiate Prescribing Guidelines Following Hip Arthroscopy (NCT NCT04169113)
NCT ID: NCT04169113
Last Updated: 2020-10-05
Results Overview
minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
111 participants
Primary outcome timeframe
Baseline (pre-operative)
Results posted on
2020-10-05
Participant Flow
Participant milestones
| Measure |
Group 1 (60) - Hip Arthroscopy
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
59
|
|
Overall Study
COMPLETED
|
47
|
53
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1 - Hip Arthroscopy
n=52 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 - Hip Arthroscopy
n=59 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=52 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=111 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=52 Participants
|
59 Participants
n=59 Participants
|
111 Participants
n=111 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=52 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=111 Participants
|
|
Age, Continuous
|
37.8 Years
STANDARD_DEVIATION 11.2 • n=52 Participants
|
36.9 Years
STANDARD_DEVIATION 11.8 • n=59 Participants
|
37.3 Years
STANDARD_DEVIATION 11.5 • n=111 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=52 Participants
|
35 Participants
n=59 Participants
|
73 Participants
n=111 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=52 Participants
|
24 Participants
n=59 Participants
|
38 Participants
n=111 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Are you an active smoker?
Yes
|
2 Participants
n=52 Participants
|
2 Participants
n=59 Participants
|
4 Participants
n=111 Participants
|
|
Are you an active smoker?
No
|
50 Participants
n=52 Participants
|
57 Participants
n=59 Participants
|
107 Participants
n=111 Participants
|
|
If no, have you ever consistently smoked cigarettes (daily for > 1 month)?
Yes
|
6 Participants
n=52 Participants
|
10 Participants
n=59 Participants
|
16 Participants
n=111 Participants
|
|
If no, have you ever consistently smoked cigarettes (daily for > 1 month)?
No
|
46 Participants
n=52 Participants
|
49 Participants
n=59 Participants
|
95 Participants
n=111 Participants
|
|
What is your employment status?
Employed
|
39 Participants
n=52 Participants
|
48 Participants
n=59 Participants
|
87 Participants
n=111 Participants
|
|
What is your employment status?
Unemployed
|
11 Participants
n=52 Participants
|
11 Participants
n=59 Participants
|
22 Participants
n=111 Participants
|
|
What is your employment status?
Disabled
|
2 Participants
n=52 Participants
|
0 Participants
n=59 Participants
|
2 Participants
n=111 Participants
|
|
Is this injury part of a workers compensation claim?
Yes
|
1 Participants
n=52 Participants
|
1 Participants
n=59 Participants
|
2 Participants
n=111 Participants
|
|
Is this injury part of a workers compensation claim?
No
|
51 Participants
n=52 Participants
|
58 Participants
n=59 Participants
|
109 Participants
n=111 Participants
|
|
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/codone)?
Yes
|
1 Participants
n=52 Participants
|
0 Participants
n=59 Participants
|
1 Participants
n=111 Participants
|
|
Are you currently using narcotic pain medications (ex. Norco, Vicodin, Oxycontin/codone)?
No
|
51 Participants
n=52 Participants
|
59 Participants
n=59 Participants
|
110 Participants
n=111 Participants
|
|
Do you have a personal history of illicit substance abuse?
Yes
|
1 Participants
n=52 Participants
|
0 Participants
n=59 Participants
|
1 Participants
n=111 Participants
|
|
Do you have a personal history of illicit substance abuse?
No
|
51 Participants
n=52 Participants
|
59 Participants
n=59 Participants
|
110 Participants
n=111 Participants
|
|
Do you have a family history of substance abuse (ex. prescription or illicit drugs, alcohol)?
Yes
|
9 Participants
n=52 Participants
|
8 Participants
n=59 Participants
|
17 Participants
n=111 Participants
|
|
Do you have a family history of substance abuse (ex. prescription or illicit drugs, alcohol)?
No
|
43 Participants
n=52 Participants
|
51 Participants
n=59 Participants
|
94 Participants
n=111 Participants
|
|
What is the highest level of education you attained?
Completed High School
|
5 Participants
n=52 Participants
|
12 Participants
n=59 Participants
|
17 Participants
n=111 Participants
|
|
What is the highest level of education you attained?
Undergraduate
|
31 Participants
n=52 Participants
|
30 Participants
n=59 Participants
|
61 Participants
n=111 Participants
|
|
What is the highest level of education you attained?
Graduate
|
16 Participants
n=52 Participants
|
17 Participants
n=59 Participants
|
33 Participants
n=111 Participants
|
|
What is your average yearly household income?
Less than $20,000
|
4 Participants
n=52 Participants
|
3 Participants
n=59 Participants
|
7 Participants
n=111 Participants
|
|
What is your average yearly household income?
$20,000 -$34,999
|
1 Participants
n=52 Participants
|
3 Participants
n=59 Participants
|
4 Participants
n=111 Participants
|
|
What is your average yearly household income?
$35,000 -$49,999
|
4 Participants
n=52 Participants
|
5 Participants
n=59 Participants
|
9 Participants
n=111 Participants
|
|
What is your average yearly household income?
$50,000 -$74,999
|
5 Participants
n=52 Participants
|
8 Participants
n=59 Participants
|
13 Participants
n=111 Participants
|
|
What is your average yearly household income?
$75,000 - $99,999
|
8 Participants
n=52 Participants
|
10 Participants
n=59 Participants
|
18 Participants
n=111 Participants
|
|
What is your average yearly household income?
$100,000 -$149,999
|
11 Participants
n=52 Participants
|
8 Participants
n=59 Participants
|
19 Participants
n=111 Participants
|
|
What is your average yearly household income?
$150,000 - $199,999
|
6 Participants
n=52 Participants
|
10 Participants
n=59 Participants
|
16 Participants
n=111 Participants
|
|
What is your average yearly household income?
$200,000 or more
|
12 Participants
n=52 Participants
|
12 Participants
n=59 Participants
|
24 Participants
n=111 Participants
|
|
What is your average yearly household income?
missing
|
1 Participants
n=52 Participants
|
0 Participants
n=59 Participants
|
1 Participants
n=111 Participants
|
|
Body Mass Index
|
26.2 kg/m2
STANDARD_DEVIATION 5.5 • n=52 Participants
|
27.8 kg/m2
STANDARD_DEVIATION 6.1 • n=59 Participants
|
27.1 kg/m2
STANDARD_DEVIATION 5.9 • n=111 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-operative)minimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=52 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=59 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
4.2 score on a scale
Standard Deviation 2.6
|
4.0 score on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 2 hours post-operativeminimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
5.0 score on a scale
Standard Deviation 2.1
|
4.7 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 24 hours post-operativeminimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
3.9 score on a scale
Standard Deviation 2.5
|
3.8 score on a scale
Standard Deviation 2.3
|
PRIMARY outcome
Timeframe: 48 hours post-operativeminimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
3.2 score on a scale
Standard Deviation 2.4
|
3.3 score on a scale
Standard Deviation 2.1
|
PRIMARY outcome
Timeframe: 7 days post-operativeminimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
2.3 score on a scale
Standard Deviation 2.4
|
2.2 score on a scale
Standard Deviation 1.6
|
PRIMARY outcome
Timeframe: 24 hours post-operativeNumber of prescribed narcotic pills taken in the preceding time period
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Taken
|
3.0 tablets
Standard Deviation 2.2
|
2.4 tablets
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 48 hours post-operativeNumber of prescribed narcotic medication tablets taken in the preceding time period
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Taken
|
5.2 tablets
Standard Deviation 5.7
|
4.9 tablets
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: 7 days post-operativeNumber of prescribed narcotic medication tablets taken in the preceding time period
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Taken
|
10.4 tablets
Standard Deviation 15.9
|
8.8 tablets
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: 21 days post-operativeNumber of prescribed narcotic medication tablets taken in the preceding time period
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Taken
|
10.5 tablets
Standard Deviation 16.5
|
9.2 tablets
Standard Deviation 11.1
|
PRIMARY outcome
Timeframe: 24 hours post-operativeNumber of prescribed narcotic medication tablets remaining from initial amount prescribed
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Remaining
|
57.0 tablets
Standard Deviation 2.2
|
27.6 tablets
Standard Deviation 2.5
|
PRIMARY outcome
Timeframe: 48 hours post-operativeNumber of prescribed narcotic medication tablets remaining from initial amount prescribed
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Remaining
|
54.8 tablets
Standard Deviation 5.7
|
25.1 tablets
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: 7 days post-operativeNumber of prescribed narcotic medication tablets remaining from initial amount prescribed
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Remaining
|
49.6 tablets
Standard Deviation 15.9
|
22.3 tablets
Standard Deviation 8.4
|
PRIMARY outcome
Timeframe: 21 days post-operativeNumber of prescribed narcotic medication tablets remaining from initial amount prescribed
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Opiates Remaining
|
49.5 tablets
Standard Deviation 16.5
|
22.0 tablets
Standard Deviation 7.9
|
PRIMARY outcome
Timeframe: 21 days post-operativeDays following surgery that the most recent dose of narcotic medication was taken
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Date of Last Opiate Taken
|
5.0 days
Standard Deviation 4.9
|
4.6 days
Standard Deviation 5.8
|
PRIMARY outcome
Timeframe: 21 daysminimum score: 0 = no pain, maximum score: 10 = worst imaginable pain; lower value indicates less pain reported by the patient
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Numeric Pain Rating Scale (NPRS) Pain Scores
|
2.6 score on a scale
Standard Deviation 2.3
|
2.0 score on a scale
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 24 hours postoperativelyAs reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, itchiness, nausea/vomiting
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Number of Participants Reporting Side Effects
Yes
|
16 Participants
|
18 Participants
|
|
Number of Participants Reporting Side Effects
No
|
31 Participants
|
35 Participants
|
PRIMARY outcome
Timeframe: 48 hours postoperativelyAs reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Number of Participants Reporting Side Effects
Yes
|
15 Participants
|
14 Participants
|
|
Number of Participants Reporting Side Effects
No
|
32 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: 7 days postoperativelyAs reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Number of Participants Reporting Side Effects
Yes
|
10 Participants
|
8 Participants
|
|
Number of Participants Reporting Side Effects
No
|
37 Participants
|
45 Participants
|
PRIMARY outcome
Timeframe: 21 days postoperativelyAs reported by patient. Including: blurred vision, confusion/mental fog, constipation, dizziness, drowsiness, nausea/vomiting
Outcome measures
| Measure |
Group 1 (60) - Hip Arthroscopy
n=47 Participants
Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 1 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
|
Group 2 (30) - Hip Arthroscopy
n=53 Participants
Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
Group 2 - Opiate Tablets post Hip Arthroscopy: Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
|
|---|---|---|
|
Number of Participants Reporting Side Effects
No
|
38 Participants
|
46 Participants
|
|
Number of Participants Reporting Side Effects
Yes
|
9 Participants
|
7 Participants
|
Adverse Events
Group 1 (60) - Hip Arthroscopy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2 (30) - Hip Arthroscopy
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