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Anterior Cruciate Ligament InjuriesPhase 3NCT06561035

Reduce Opiate Exposure With ACL Surgery

A Phase 3 study testing Opiate Sparing and Opiate Based in people with Anterior Cruciate Ligament Injuries, run by Campbell Clinic at 3 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 14 to 85 years
Conditions the study is for
Anterior Cruciate Ligament Injuries
What is being tested?
Opiate Sparing and Opiate Based
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
3 sitesUnited States
Study dates
1 Sep 2024to Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States3 sites

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Campbell Clinic

    Memphis, Tennessee, 38138

  • Endeavor Health

    Skokie, Illinois, 60076

Other trials in United States

About this study

Official title: 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).

Read the 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.

Being tested
Opiate Sparing, Opiate Based
Medical subject headings
Anterior Cruciate Ligament Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opiate SparingDrug

    Also called Opiate-sparing

    Subjects will receive medications in the Opiate Sparing arm for pain control.

  • Opiate BasedDrug

    Also called Opiate=based

    Subjects will receive medications in the Opiate Based arm for pain control.

Study groups in NCT06561035
Study groupRoleWhat they receive
Opiate SparingExperimentalDischarge medications: 1. Medrol Dosepak, take per package instructions from postoperative day 1 to postoperative day 6. 2. Diclofenac 75 milligram (mg) twice per day from postoperative day 7 to postoperative day 14. 3. Tylenol 1000 mg three times per day from postoperative day 1 to postoperative day 14. 4. Gabapentin 100 mg three times per day from postoperative day 1 to postoperative day 14. 5. Methocarbamol (Robaxin) 750mg twice per day from postoperative day 1 to postoperative day 14. 6. Promethazine 25 mg every 8 hours as needed for nausea. 7. Aspirin 81 once per day from postoperative day 1 to postoperative day 30. 8. Senokot-S (Sennosides and Docusate) as needed for constipation. 9. 10 tablets of Tramadol 50mg as needed for moderate breakthrough pain only. 10. 5 tablets of oxycodone 5mg as needed for severe breakthrough pain only. 11. Supervised physical therapy to start within postoperative day 2 and postoperative day 7.
Receives: Drug: Opiate Sparing
Opiate BasedActive comparatorDischarge medications: 1. Diclofenac 75 milligram (mg) twice per day from postoperative day 1 to postoperative day 14. 2. Tylenol 1000 mg three times per day from postoperative day 1 to postoperative day 14. 3. Gabapentin 100 mg three times per day from postoperative day 1 to postoperative day 14. 4. Methocarbamol (Robaxin) 750mg twice per day from postoperative day 1 to postoperative day 14. 5. Promethazine 25 mg every 8 hours as needed for nausea. 6. Aspirin 81 once per day from postoperative day 1 to postoperative day 30. 7. Senokot-S (Sennosides and Docusate) as needed for constipation. 8. 10 tablets of Tramadol 50mg as needed for moderate breakthrough pain only. 9. 5 tablets of oxycodone 5mg as needed for severe breakthrough pain only. 10. Supervised physical therapy to start within postoperative day 2 and postoperative day 7.
Receives: Drug: Opiate Based

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale

    Record pain score with 0 being no pain at all and 10 being worst pain possible.

    Measured: 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.

  2. Oral morphine equivalent

    Opiate pill count

    Measured: 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 outcomes (1)

  1. Incidence of treatment-emergent adverse event.

    Adverse event occurrence

    Measured: From day of surgery to 12-week follow up visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2024
  2. Study start1 Sep 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06561035
Sponsor's protocol ID
24-09976-FB
Status last verified
Sep 2026
First submitted
16 Aug 2024
Last updated
15 Sep 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 21467282

  • 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.

    PubMed 28711636

  • 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.

    PubMed 36194219

  • 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.

    PubMed 35803549

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Opiate Sparing and Opiate Based in people with Anterior Cruciate Ligament Injuries, run by Campbell Clinic at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06561035, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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