Anterior Cruciate Ligament Rupture Clinical Trial
Official title:
Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction
Verified date | September 2023 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 98 |
Est. completion date | September 19, 2022 |
Est. primary completion date | September 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Emory clinic at Executive Park | Atlanta | Georgia |
United States | The Emory Clinic | Atlanta | Georgia |
United States | Emory Orthopedic and spine Hospital | Tucker | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Orthopedic Research and Education Foundation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | Postoperative days 0-6, 6 weeks post-surgery | |
Other | 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. | Postoperative days 0-6, 6 weeks post-surgery | |
Other | 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. | Postoperative days 0-6, 6 weeks post-surgery | |
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). | Postoperative days 0-6 |
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