Trial Outcomes & Findings for Are Opioids Needed After ACL Reconstruction (NCT NCT04285853)
NCT ID: NCT04285853
Last Updated: 2023-10-11
Results Overview
Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
98 participants
Primary outcome timeframe
Postoperative days 0-6
Results posted on
2023-10-11
Participant Flow
Participant milestones
| Measure |
Oxycodone Arm
Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
|
Placebo Arm
Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
49
|
|
Overall Study
COMPLETED
|
39
|
44
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
| Measure |
Oxycodone Arm
Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
|
Placebo Arm
Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
5
|
Baseline Characteristics
Are Opioids Needed After ACL Reconstruction
Baseline characteristics by cohort
| Measure |
Oxycodone Arm
n=49 Participants
Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
|
Placebo Arm
n=49 Participants
Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.6 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
20.6 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
21.6 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
34 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
29 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
Body mass index
|
24.0 kg/m2
STANDARD_DEVIATION 3.7 • n=5 Participants
|
23.6 kg/m2
STANDARD_DEVIATION 3.8 • n=7 Participants
|
23.8 kg/m2
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Smoking status
Not a smoker
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Smoking status
Current Cigarette User
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Smoking status
Former smoker
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Smoking status
Unknown status
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Current use of alcohol
Yes
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Current use of alcohol
No
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Current use of alcohol
Did not provide an answer
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Currently on treatment for depression
Yes
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Currently on treatment for depression
No
|
45 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
92 Participants
n=5 Participants
|
|
ADHD treatment
Yes
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
ADHD treatment
No
|
46 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Preoperative opioid use
Yes
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Preoperative opioid use
No
|
49 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Postoperative days 0-6Population: Number analyzed in one or more rows differs from overall number analyzed depending on the number of patients that were able to provide data about their level of pain.
Patients will record pain levels on Numeric Rating Scale 1-10, where 1 is minimal pain and 10 is associated with highest level of pain (worse outcome).
Outcome measures
| Measure |
Oxycodone Arm
n=40 Participants
Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
|
Placebo Arm
n=42 Participants
Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
|
|---|---|---|
|
Pain Level: Numeric Rating Scale
Study Day 0
|
4.6 score on a scale
Interval 3.9 to 5.2
|
4.5 score on a scale
Interval 4.0 to 5.1
|
|
Pain Level: Numeric Rating Scale
Study Day 1
|
4.7 score on a scale
Interval 4.1 to 5.2
|
5.1 score on a scale
Interval 4.5 to 5.6
|
|
Pain Level: Numeric Rating Scale
Study Day 2
|
3.8 score on a scale
Interval 3.2 to 4.3
|
3.8 score on a scale
Interval 3.3 to 4.4
|
|
Pain Level: Numeric Rating Scale
Study Day 3
|
3.0 score on a scale
Interval 2.6 to 3.5
|
3.3 score on a scale
Interval 2.8 to 3.9
|
|
Pain Level: Numeric Rating Scale
Study Day 4
|
3.0 score on a scale
Interval 2.4 to 3.5
|
3.0 score on a scale
Interval 2.4 to 3.5
|
|
Pain Level: Numeric Rating Scale
Study Day 5
|
2.6 score on a scale
Interval 2.1 to 3.2
|
2.9 score on a scale
Interval 2.4 to 3.5
|
|
Pain Level: Numeric Rating Scale
Study Day 6
|
2.9 score on a scale
Interval 1.8 to 4.0
|
2.8 score on a scale
Interval 2.3 to 3.4
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Postoperative days 0-6, 6 weeks post-surgerywill be conducted with digital pressure dolorimeter (Wagner Force One Model FDIX 50TM, Wagner Instruments). Pressure dolorimeters are devices that measure pressure/pain threshold. The device will be held perpendicular to the areas to be tested. The force will be increased at a constant rate of 1 kg/cm2. Patients will be instructed to express pain either by saying "ouch" or raising their hand when pain is felt. The force read on the digital dolorimeters will be recorded. This procedure will be repeated 3 times. Both right and left sides will be tested.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Postoperative days 0-6, 6 weeks post-surgeryIt will be determined with the Pain Catastrophizing Scale (PCS). Pain catastrophizing is described as "an exaggerated negative mental set brought to bear during actual or anticipated painful experience." In other words, it is a feeling of helplessness. The PCS is a 13-item questionnaire that inquires about thoughts and feelings a patient experiences when in pain. Responses are recorded on a 5-point Likert scale ("not at all" to "all the time"). A total score is yielded ranging from 0-52. Higher score is associated with worse outcome.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Postoperative days 0-6, 6 weeks post-surgeryQuality of life will be measured with the instrument Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D is a standardized measure of health status that measures five dimensions, Mobility, Self-care, Daily activities, Pain/Discomfort, Anxiety/ Depression. Each dimension can be rated at five levels: from no problems to major problems. The five dimensions can be summed into a descriptive health state with 11111 representing no problems in any of the five health dimensions and 55555 indicating major problems in any of the five health dimensions.
Outcome measures
Outcome data not reported
Adverse Events
Oxycodone Arm
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo Arm
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oxycodone Arm
n=49 participants at risk
Patients in this opioid group will receive 15 oral opioid tablets (5 mg oxycodone) Patients will also receive 8 "rescue" medications, in the Oxycodone arm will be placebo "rescue" medications.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Oxycodone: 5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
|
Placebo Arm
n=49 participants at risk
Patients in placebo group will receive 15 placebo tablets. All patients will also receive 8 "rescue" medications: Patients who randomize to the non-opioid arm will receive 5mg oxycodone "rescue" tablets.
All participants will also receive the following as part of standard of care:
1. Oral non-opioid (1000 mg acetaminophen), every 8 hours.
2. Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
3. Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
4. Intraoperative education on post-surgical pain management.
Placebo oral tablet: Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.
|
|---|---|---|
|
Psychiatric disorders
Euphoria
|
0.00%
0/49 • Up to 6 weeks post-operatively
|
2.0%
1/49 • Number of events 1 • Up to 6 weeks post-operatively
|
|
Gastrointestinal disorders
Nausea and vomiting
|
10.2%
5/49 • Number of events 5 • Up to 6 weeks post-operatively
|
4.1%
2/49 • Number of events 2 • Up to 6 weeks post-operatively
|
|
Gastrointestinal disorders
Constipation
|
20.4%
10/49 • Number of events 10 • Up to 6 weeks post-operatively
|
8.2%
4/49 • Number of events 4 • Up to 6 weeks post-operatively
|
|
General disorders
Other
|
2.0%
1/49 • Number of events 1 • Up to 6 weeks post-operatively
|
4.1%
2/49 • Number of events 2 • Up to 6 weeks post-operatively
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place