NCT06561035

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
18mo left

Started Sep 2024

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Sep 2024Mar 2028

First Submitted

Initial submission to the registry

August 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

3.2 years

First QC Date

August 16, 2024

Last Update Submit

September 10, 2026

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    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

    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 Outcomes (1)

  • Incidence of treatment-emergent adverse event.

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

Study Arms (2)

Opiate Sparing

EXPERIMENTAL

Discharge 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.

Drug: Opiate Sparing

Opiate Based

ACTIVE COMPARATOR

Discharge 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.

Drug: Opiate Based

Interventions

Opiate SparingDRUG

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

Also known as: Opiate-sparing
Opiate Sparing
Opiate BasedDRUG

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

Also known as: Opiate=based
Opiate Based

Eligibility Criteria

Age14 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Endeavor Health

Skokie, Illinois, 60076, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Campbell Clinic

Memphis, Tennessee, 38138, United States

Location

Related Publications (4)

  • 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.

    PMID: 21467282RESULT

  • 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.

    PMID: 28711636RESULT

  • 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.

    PMID: 36194219RESULT

  • 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.

    PMID: 35803549RESULT

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Frederick Azar, MD

    Campbell Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Orthopaedic Surgery and Biomechanical Engineering

Study Record Dates

First Submitted

August 16, 2024

First Posted

August 19, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

September 15, 2026

Record last verified: 2026-09

Locations

US(3)