ACL-R Opioid Sparing Study

NCT06561035 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: 24-09976-FB
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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).

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 Sparing DRUG

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

Opiate Sparing

Opiate Based DRUG

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

Opiate Based

Eligibility Criteria

• Age: 14 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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.

Sponsors & Collaborators

• Campbell Clinic: lead

Study Sites (1)

Campbell Clinic

Memphis, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Joseph Lamplot, 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: Associate 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: August 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Locations

US (1)