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Completed

NCT Number: NCT04285853

Are Opioids Needed After ACL Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

14 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Emory clinic at Executive Park, Atlanta, Georgia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxycodone

Drug

5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10

Other names: Xtampza ER, Oxaydo, Roxicodone, and Oxycontin

Placebo oral tablet

Drug

Placebo tablets (both trial and "rescue") will be matched to size, shape, color, and texture of oxycodone tablets.

Primary outcomes

  1. Pain Level: Numeric Rating Scale

    Time frame: 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 outcomes

  1. Change in Pain Threshold Testing

    Time frame: 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.

  2. Change in Pain Catastrophizing Scale (PCS)

    Time frame: 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.

  3. Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • Orthopedic Research and Education Foundation

Registry information

Official study title

Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 26, 2020
Registry last updated
Oct 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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