Post-Op Pain Control for Prophylactic Intramedullary Nailing.

Part of paid clinical trials in St Louis, Missouri.

Sponsor
St. Louis University
Study ID
NCT03823534
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ketorolac — DRUG
    IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
  • Normal saline — DRUG
    An IV normal saline placebo prepared by the hospital pharmacy.
  • Acetaminophen — DRUG
    acetaminophen 500 mg PO Q4 hours PRN for mild pain
  • Oxycodone Acetaminophen — DRUG
    oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
  • Morphine — DRUG
    morphine IV PRN (or other opioid) for severe breakthrough pain
  • Hydrocodone/Acetaminophen — DRUG
    At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours. Those with preexisting liver disease will be prescribed the equivalent in oxycodone.
  • Oxycodone — DRUG
    Upon discharge, patients will be prescribed the equivalent of 1-2 hydrocodone 5mg Q4 hours upon should they have preexisting liver disease and are unable to consume acetaminophen.

Study Details

Nationally, the opioid crisis has become a major epidemic with increasing mortality rates each year. Orthopedic surgeons routinely prescribe narcotics instead of NSAIDs for post-op pain control because of risk of delayed healing and nonunion due to NSAID use. Orthopedic oncology, however, has a unique subset of patients that undergo prophylactic placement of intramedullary femoral nails. Because no fracture is present, these patients do not rely on inflammatory healing factors, allowing for post-op NSAID use. This study sets out to determine the effect of post-op toradol use in addition to opioids compared to solely opioids in patients undergoing prophylactic nailing of the femur.

Key Dates

Start date
Feb 20, 2019
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

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

Arms

  • Experimental: Experimental Arm
    For the first 24 hours following surgery, patients younger than 65 years old will be administered a maximum of 120 mg/day bolus IV ketorolac (30 mg every 6 hours). Patients older than 65 years old or with history of advanced renal impairment will receive a maximum of 60 mg/day bolus IV ketorolac (15 mg every 6 hours). All patients may also be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate- severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. At discharge, they will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours, quantity 50. Those with preexisting liver disease will be prescribed the equivalent in oxycodone and will not receive acetaminophen for mild pain.
  • Placebo Comparator: Control
    Following surgery, patients will be given acetaminophen 500 mg PO Q4 hours PRN for mild pain, oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate-severe pain, and morphine IV PRN (or other opioid) for severe breakthrough pain while hospitalized. They will also be given a placebo injection of normal saline every 6 hours for the first 24 hours following surgery. At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours PRN quantity 50, unless they have preexisting liver disease, in which case they will be prescribed the equivalent in oxycodone. They will not receive a nerve block.

Primary Outcome Measure

Milligram Morphine Equivalent (MME) of Opioid Medications Utilized [ Time Frame: Post-op days 1-14 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Saint Louis UniversitySt LouisMissouri63110
Allison Gruender, MSN
[email protected]
314-617-3406

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