Are Opioids Needed After ACL Reconstruction

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285853
• Other study ID #: IRB00116728
• Status: Completed
• Phase: Phase 4
• Start date: September 16, 2020
• Est. completion date: September 19, 2022

Study information

• Verified date: September 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

Drug:
• Oxycodone
5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
• Placebo oral tablet
Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Orthopedic Research and Education Foundation

Country where clinical trial is conducted

United States, 

Outcome

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