ACL-R Opioid Sparing Study

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
Campbell Clinic
Study ID
NCT06561035
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Anterior Cruciate Ligament Injuries

Eligibility Criteria

Sex
ALL
Age
14 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Opiate Sparing — DRUG
    Subjects will receive medications in the Opiate Sparing arm for pain control.
  • Opiate Based — DRUG
    Subjects will receive medications in the Opiate Based arm for pain control.

Study Details

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).

Key Dates

Start date
Sep 1, 2024
Status verified
Aug 2024
Primary completion
Aug 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Opiate Sparing
    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.
  • Active Comparator: Opiate Based
    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.

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. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Campbell ClinicMemphisTennessee38138-

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