Anterior Cruciate Ligament Rupture
Conditions
Keywords
Opioids
Brief summary
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation.
Detailed description
As the public health sector continues to confront the opioid epidemic, orthopaedic surgeons must revisit pain management protocols to reduce unnecessary opioid prescriptions. The long-term goal is to reduce opioid use and residual opioids in circulation. The purposes are to 1) conduct a double-blinded randomized controlled trial to determine the effectiveness of opioid versus non-opioid medications on post-surgical pain, and 2) examine predictors of opioid usage in individuals following Anterior Cruciate ligament (ACL) reconstruction. Patients will use an innovative Smartphone application to track pain and medication usage. Additionally, patients will complete quality of life and pain catastrophizing questionnaires, as well as undergo pain threshold testing, to be used in a model to determine predictors of greater post-surgical opioid use. This study will provide information on non-opioid alternatives and specific predictors of post-surgical opioid use that can be used to develop prescribing protocols. These findings will help orthopaedic surgeons make informed decisions when tailoring individualized prescriptions for patients following ACL reconstruction. Importantly, findings will be readily translatable into research to reduce opioid use in other orthopaedic surgical cohorts as well. Our ultimate goal is to lessen the burden of the opioid epidemic on not only our orthopaedic patients, but also society, by minimizing the number of opioids left in circulation.
Interventions
DRUGOxycodone
5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
DRUGPlacebo oral tablet
Placebo tablets (both trial and rescue) will be matched to size, shape, color, and texture of oxycodone tablets.
Sponsors
Orthopedic Research and Education Foundation
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both participants and PI (orthopaedic surgeon) will be blinded. Placebo pills will be closely matched to oxycodone pills, so patients will not know to which group they are allocated. The PI will be blinded to group allocation.
Intervention model description
Prospective, double-blind, randomized controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Males and females * Aged 14-40 years * Scheduled for primary (Anterior cruciate ligament) ACL reconstruction using quadriceps tendon autograft.
Exclusion criteria
* Revision and/or contralateral ACL reconstruction procedures * Allergies to local anesthetics * Chronic pain medication use * Weight \<50 kg, local infections * Known coagulopathies, * Liver dysfunction or renal failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level: Numeric Rating Scale | Postoperative days 0-6 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Threshold Testing | Postoperative days 0-6, 6 weeks post-surgery | will 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. |
| Change in Pain Catastrophizing Scale (PCS) | Postoperative days 0-6, 6 weeks post-surgery | It 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. |
| Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D | Postoperative days 0-6, 6 weeks post-surgery | Quality 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 49 |
| 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. | 49 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 9 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo Arm | Oxycodone Arm |
|---|---|---|---|
| ADHD treatment No | 93 Participants | 47 Participants | 46 Participants |
| ADHD treatment Yes | 5 Participants | 2 Participants | 3 Participants |
| Age, Continuous | 21.6 years STANDARD_DEVIATION 6.3 | 20.6 years STANDARD_DEVIATION 5.7 | 22.6 years STANDARD_DEVIATION 6.9 |
| Body mass index | 23.8 kg/m2 STANDARD_DEVIATION 3.7 | 23.6 kg/m2 STANDARD_DEVIATION 3.8 | 24.0 kg/m2 STANDARD_DEVIATION 3.7 |
| Currently on treatment for depression No | 92 Participants | 47 Participants | 45 Participants |
| Currently on treatment for depression Yes | 6 Participants | 2 Participants | 4 Participants |
| Current use of alcohol Did not provide an answer | 45 Participants | 23 Participants | 22 Participants |
| Current use of alcohol No | 32 Participants | 18 Participants | 14 Participants |
| Current use of alcohol Yes | 21 Participants | 8 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 12 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 0 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 71 Participants | 37 Participants | 34 Participants |
| Preoperative opioid use No | 97 Participants | 48 Participants | 49 Participants |
| Preoperative opioid use Yes | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 62 Participants | 33 Participants | 29 Participants |
| Race (NIH/OMB) White | 22 Participants | 8 Participants | 14 Participants |
| Region of Enrollment United States | 98 participants | 49 participants | 49 participants |
| Sex: Female, Male Female | 48 Participants | 22 Participants | 26 Participants |
| Sex: Female, Male Male | 50 Participants | 27 Participants | 23 Participants |
| Smoking status Current Cigarette User | 2 Participants | 0 Participants | 2 Participants |
| Smoking status Former smoker | 1 Participants | 0 Participants | 1 Participants |
| Smoking status Not a smoker | 68 Participants | 34 Participants | 34 Participants |
| Smoking status Unknown status | 27 Participants | 15 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 49 | 0 / 49 |
| other Total, other adverse events | 15 / 49 | 8 / 49 |
| serious Total, serious adverse events | 0 / 49 | 0 / 49 |
Outcome results
Primary
Pain Level: Numeric Rating Scale
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).
Time frame: Postoperative days 0-6
Population: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Oxycodone Arm | Pain Level: Numeric Rating Scale | Study Day 0 | 4.6 score on a scale |
| Oxycodone Arm | Pain Level: Numeric Rating Scale | Study Day 1 | 4.7 score on a scale |
| Oxycodone Arm | Pain Level: Numeric Rating Scale | Study Day 2 | 3.8 score on a scale |
| Oxycodone Arm | Pain Level: Numeric Rating Scale | Study Day 3 | 3.0 score on a scale |
| Oxycodone Arm | Pain Level: Numeric Rating Scale | Study Day 4 | 3.0 score on a scale |
| Oxycodone Arm | Pain Level: Numeric Rating Scale | Study Day 5 | 2.6 score on a scale |
| Oxycodone Arm | Pain Level: Numeric Rating Scale | Study Day 6 | 2.9 score on a scale |
| Placebo Arm | Pain Level: Numeric Rating Scale | Study Day 2 | 3.8 score on a scale |
| Placebo Arm | Pain Level: Numeric Rating Scale | Study Day 0 | 4.5 score on a scale |
| Placebo Arm | Pain Level: Numeric Rating Scale | Study Day 4 | 3.0 score on a scale |
| Placebo Arm | Pain Level: Numeric Rating Scale | Study Day 1 | 5.1 score on a scale |
| Placebo Arm | Pain Level: Numeric Rating Scale | Study Day 6 | 2.8 score on a scale |
| Placebo Arm | Pain Level: Numeric Rating Scale | Study Day 5 | 2.9 score on a scale |
| Placebo Arm | Pain Level: Numeric Rating Scale | Study Day 3 | 3.3 score on a scale |
Other Pre-specified
Change in Pain Catastrophizing Scale (PCS)
It 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.
Time frame: Postoperative days 0-6, 6 weeks post-surgery
Other Pre-specified
Change in Pain Threshold Testing
will 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.
Time frame: Postoperative days 0-6, 6 weeks post-surgery
Other Pre-specified
Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D
Quality 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.
Time frame: Postoperative days 0-6, 6 weeks post-surgery