Reduce Opiate Exposure With ACL Surgery
September 10, 2026 updated by: Frederick Azar, Campbell Clinic
Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery
This is a randomized control trial to investigate the effectiveness of a multimodal opiate sparing analgesic regimen in controlling post-operative pain and potentially reduce post-operative opioid consumption in patients undergoing Anterior Cruciate Ligament Reconstruction (ACL-R).
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
There is increased attention on opioid prescription patterns and post-operative narcotic consumption in light of the ongoing opioid crisis in the United States. Patients with opioid use disorders often have their first exposure to opioids following a medical or surgical procedure. Approximately 6% of patients who were opioid native preoperatively and received opioids postoperatively became long term users. As orthopedic surgeons account for approximately 8% of all dispensed opioid prescriptions, surgeons have investigated the effectiveness of multimodal analgesic regimens in controlling post-operative pain and reducing the amount of opioid consumption. Recent studies have shown that an opiate sparing regimen consisted of nonsteroidal anti-inflammatory drugs can control post-operative pain adequately while reducing opioid consumption in patients who underwent arthroscopic knee or shoulder surgeries. Currently, there is no clear consensus on pain management regimen after anterior cruciate ligament reconstruction.
The purpose of this study is to 1) investigate the difference in pain score and opioid consumption among patients who receive the opioid-based protocol and those who receive opioid-sparing protocol; 2) minimize and potentially eliminate the utilization of narcotics following anterior cruciate ligament reconstruction (ACL-R) surgery.
Study Type
Interventional
Enrollment (Estimated)
56
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Skokie, Illinois, United States, 60076
- Endeavor Health
-
-
Ohio
-
Cincinnati, Ohio, United States, 45267
- University of Cincinnati
-
-
Tennessee
-
Memphis, Tennessee, United States, 38138
- Campbell Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 14-85 years of age.
- Patients undergoing primary ACL-R with or without meniscus repair or meniscectomy, with or without chondroplasty.
- Patients weigh at least 90lbs at time of enrollment.
- Surgery scheduled at a Campbell Clinic Surgery Center (Midtown or Wolf River).
- Willing and able to provide written informed consent.
- Willing and able to cooperate with postoperative therapy.
- Speak and read fluent English.
Exclusion Criteria:
- Multiligament knee reconstruction.
- Pre-injury opioid consumption.
- Substance abuse disorder (illicit drug abuse, alcoholism, etc).
- Concomitant injuries or surgeries warranting pain medication (i.e. polytrauma patient).
- Chronic pain syndrome.
- Renal disease.
- Currently taking selective serotonin reuptake inhibitors and/or serotonin and norepinephrine reuptake inhibitors.
- Known sensitivity, allergy, or intolerance to medications within protocols.
- History of diabetes.
- Currently taking glucagon-like peptide 1 agonist.
- Female patient who is pregnant on day of surgery or becomes pregnant during study period.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Opiate Sparing
Discharge medications:
|
Subjects will receive medications in the Opiate Sparing arm for pain control.
Other Names:
|
|
Active Comparator: Opiate Based
Discharge medications:
|
Subjects will receive medications in the Opiate Based arm for pain control.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit.
|
Record pain score with 0 being no pain at all and 10 being worst pain possible.
|
Once per day from postoperative day 1 to postoperative day 14; at two weeks follow up visit, 6 weeks follow up visit and 12 weeks follow up visit.
|
|
Oral morphine equivalent
Time Frame: daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit.
|
Opiate pill count
|
daily pill count from postoperative day 1 to postoperative day 14; at 2-week follow up visit, 6-week follow up visit and 12-week follow up visit.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of treatment-emergent adverse event.
Time Frame: From day of surgery to 12-week follow up visit.
|
Adverse event occurrence
|
From day of surgery to 12-week follow up visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Frederick Azar, MD, Campbell Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Volkow ND, McLellan TA, Cotto JH, Karithanom M, Weiss SR. Characteristics of opioid prescriptions in 2009. JAMA. 2011 Apr 6;305(13):1299-301. doi: 10.1001/jama.2011.401. No abstract available.
- Shah A, Hayes CJ, Martin BC. Factors Influencing Long-Term Opioid Use Among Opioid Naive Patients: An Examination of Initial Prescription Characteristics and Pain Etiologies. J Pain. 2017 Nov;18(11):1374-1383. doi: 10.1016/j.jpain.2017.06.010. Epub 2017 Jul 13.
- NO PAin Investigators; Gazendam A, Ekhtiari S, Horner NS, Simunovic N, Khan M, de Sa DL, Madden K, Ayeni OR. Effect of a Postoperative Multimodal Opioid-Sparing Protocol vs Standard Opioid Prescribing on Postoperative Opioid Consumption After Knee or Shoulder Arthroscopy: A Randomized Clinical Trial. JAMA. 2022 Oct 4;328(13):1326-1335. doi: 10.1001/jama.2022.16844.
- Jones CA, Throckmorton TW, Murphy J, Eason RR, Joyce M, Bernholt DL, Azar FM, Brolin TJ. Opioid-sparing pain management protocol after shoulder arthroplasty results in less opioid consumption and higher satisfaction: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2022 Oct;31(10):2057-2065. doi: 10.1016/j.jse.2022.05.029. Epub 2022 Jul 5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
March 1, 2028
Study Registration Dates
First Submitted
August 16, 2024
First Submitted That Met QC Criteria
August 16, 2024
First Posted (Actual)
August 19, 2024
Study Record Updates
Last Update Posted (Actual)
September 15, 2026
Last Update Submitted That Met QC Criteria
September 10, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-09976-FB
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.