Clinical trial NCT04285853: Are Opioids Needed After ACL Reconstruction
Official title: Are Opioids Needed: A Double-Blinded, Randomized Controlled Trial and Examination of Predictors of Opioid Use Following ACL Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Opioids
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Orthopedic Research and Education Foundation
First posted: 2020-02-26
Enrollment: 98
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, double-blind, randomized controlled clinical trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain Level: Numeric Rating Scale
timeFrame: Postoperative days 0-6
Secondary outcomes:
Other outcomes:
measure: Change in Pain Threshold Testing
timeFrame: Postoperative days 0-6, 6 weeks post-surgery
measure: Change in Pain Catastrophizing Scale (PCS)
timeFrame: Postoperative days 0-6, 6 weeks post-surgery
measure: Change in Quality of Life: Euro Quality of Life Index (Euro QoL 5-D 5-L) EQ-5D
timeFrame: Postoperative days 0-6, 6 weeks post-surgery
Locations:
city: Atlanta
country: United States
facility: The Emory Clinic
state: Georgia
city: Atlanta
country: United States
facility: Emory clinic at Executive Park
state: Georgia
city: Tucker
country: United States
facility: Emory Orthopedic and spine Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: John Xerogeanes, MD
role: PRINCIPAL_INVESTIGATOR
References: