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OpenTrials
Enrolling by invitation

NCT Number: NCT06561035

Reduce Opiate Exposure With ACL 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).

Enrolling by invitation

Interested in participating?

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Key information

Age range

14 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Endeavor Health, Skokie, Illinois, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Opiate Sparing

Drug

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

Other names: Opiate-sparing

Opiate Based

Drug

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

Other names: Opiate=based

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Incidence of treatment-emergent adverse event.

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

    Adverse event occurrence

Interested in participating?

Enrolling by invitation

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Campbell Clinic

Other

Registry information

Official study title

Opiate Sparing Pain Management Protocol After Anterior Cruciate Ligament Reconstruction Surgery

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 19, 2024
Registry last updated
Sep 15, 2026

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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