Dr. X Rehab Videos

Research

Advancing Sports Medicine and Patient Care

Are Opioids Needed Study

To determine if opioids are needed following ACL surgery

If you meet the eligibility requirements and choose to participate in this study, prior to your ACL surgery, you will be randomized (like flipping a coin) and blinded (don’t know which group you are in) to receive oxycodone (opioid) or placebo tablets.

Regardless of which group you are in, you will receive the following as part of standard of care:

  • Oral non-opioid (acetaminophen 1000 mg), to be used every 8 hours.
  • Prescription of non-opioid non-steroidal anti-inflammatory medication (naproxen 500 mg) to be used 2x/day post-surgery.
  • Standardized multimodal intra- and post-operative protocols, including an adductor canal peripheral nerve block.
  • Intraoperative education on post-surgical pain management. This includes encouragement, regardless of group allocation, to not use opioids, if not needed (pain levels <7 on Numeric Rating Scale). (We will tell you to consider using the opioid medication if intense pain prevents you from watching your favorite show, enjoying your meals, talking with friends, etc.)

If you are assigned to the opioid group, you will receive 15 oral opioid tablets (5 mg oxycodone).

If you are assigned to the placebo group, you will receive 15 placebo tablets.

You will also receive 8 “rescue” medications: If you are in the opioid arm you will be given placebo “rescue” medications, and if you are in the non-opioid arm you will receive 5mg oxycodone “rescue” tablets.

You will not be able to tell the difference between oxycodone and placebo tablets. These “rescue” medications are to be used only if pain is >8 (on Numeric Rating Scale 1-10) and does not improve within 4 hours of taking prior pain medication.

Following your surgery, researchers will ask you to:

  • Record your medication usage, pain levels and side effects
  • Participate in clinical and questionnaire assessments

Note: All of these procedures will be paid for by the study

  • Helping researchers answer study questions
  • Contributing to scientific development
  • Visits, follow-up calls and other study-related practices may take up additional time
  • Possibility of increased pain or discomfort
  • Possibility of loss of privacy or breach of confidentiality

To participate in this study, patients must meet all of the following criteria:

  • 14 – 40 years old
  • Undergoing primary ACL reconstruction with a QT autograft
  • Procedure is not a revision or contralateral ACL reconstruction
  • No allergies to local anesthetics
  • No chronic pain medication use
  • Weight >= 50kg
  • No local infections, known coagulopathies, liver dysfunction or renal failure
  • No concomitant procedures (Complex meniscal repair of multi-ligament reconstruction)

For more information on this study, please visit this website or reach out to Dr. Xerogeanes and his team directly.