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Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

Primary Purpose

Ketorolac, Joint Fusion

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
great toe (1st metatarsophalangeal joint) fusion
IV Ketorolac
Ketorolac Pill
5/325mg Oxycodone-Acetaminophen
Aspirin 81Mg Ec Tab
Sponsored by
Rothman Institute Orthopaedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ketorolac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients over the age of 18 undergoing outpatient primary 1st MTPJ fusion by a fellowship-trained foot and ankle orthopaedic surgeon at the Rothman Orthopaedic Institute

Exclusion Criteria:

  • Patients undergoing revision 1st MTPJ fusion;
  • Patients with any allergies to any study medication;
  • Patients with documented chronic narcotic use;
  • Patients with renal insufficiency, as defined by history and preoperative creatinine level (Cr ≥ 2.1 mg/dl);
  • Patients who are pregnant;
  • Patients undergoing inpatient procedure.

Sites / Locations

  • Rothman Orthopaedic Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ketorolac administration

No Ketorolac administration

Arm Description

Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain

Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain

Outcomes

Primary Outcome Measures

Postoperative Pain
Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain
Satisfaction with pain management
This will be measured using the 6-point Likert scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied)
Participant Perception of Pain
This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always)

Secondary Outcome Measures

Full Information

First Posted
May 3, 2021
Last Updated
May 3, 2021
Sponsor
Rothman Institute Orthopaedics
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1. Study Identification

Unique Protocol Identification Number
NCT04872283
Brief Title
Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion
Official Title
Prospective Randomized Study Evaluating the Effect of Postoperative Ketorolac on Bone Healing and Opioid Consumption After First Metatarsophalangeal Joint Fusion
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
In the midst of the opioid crisis, the use of non-narcotic pain medication has garnered increased interest, particularly in the field of orthopaedic surgery, where narcotic medications are routinely prescribed postoperatively. Nonsteroidal anti-inflammatory drugs (NSAIDs) have the potential to serve as an adjunct analgesic, but many orthopaedic surgeons have viewed NSAIDs with hesitancy because of evidence that they can lead to delayed bone healing. When evaluating bone healing across different NSAID formulas, ketorolac was found to cause no delay and lead to better union rates when compared to controls and other NSAIDs, respectively. Previous studies in the orthopaedic spine and trauma literature have suggested a detrimental effect of NSAIDs, specifically ketorolac, with regards to bone healing, while others have reported no delay in healing. A recent study from our institution found no detrimental effects on the healing of ankle fractures with the use of ketorolac in the immediate postoperative period. Additionally, the use of ketorolac was associated with less reliance on narcotic pain medications. The purpose of this prospective randomized study is to evaluate the use of ketorolac on postoperative pain, opioid requirements, patient satisfaction, complication/reoperation rates, and delayed and/or nonunion rates in patients undergoing fusion of their first metatarsophalangeal joint (1st MTPJ) for treatment of end-stage arthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketorolac, Joint Fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients will be blinded at enrollment and first made aware to which intervention they were randomized when receiving their postoperative pain medication at outside pharmacies
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac administration
Arm Type
Active Comparator
Arm Description
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive 30 mg of IV ketorolac during surgery as well as 20 mg ketorolac pills to take after surgery for pain
Arm Title
No Ketorolac administration
Arm Type
Active Comparator
Arm Description
Participants who have surgery for great toe (1st metatarsophalangeal joint) fusion will receive the standard treatment of 30 tablets of oxycodone-acetaminophen to take as needed for pain
Intervention Type
Procedure
Intervention Name(s)
great toe (1st metatarsophalangeal joint) fusion
Intervention Description
Great Toe joint fusion surgery
Intervention Type
Drug
Intervention Name(s)
IV Ketorolac
Intervention Description
Participants will receive 30mg of intravenous (IV) ketorolac will be given during surgery
Intervention Type
Drug
Intervention Name(s)
Ketorolac Pill
Intervention Description
Participants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain
Intervention Type
Drug
Intervention Name(s)
5/325mg Oxycodone-Acetaminophen
Intervention Description
Participants will receive 30 tablets of 5/325mg oxycodone-acetaminophen with instructions to take 1 or 2 tablets by mouth every 4 to 6 hours as needed for pain
Intervention Type
Drug
Intervention Name(s)
Aspirin 81Mg Ec Tab
Intervention Description
Participants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT)
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Participants will be asked to complete the Visual Analog Scale for Pain Survey to measure postoperative pain
Time Frame
7 days
Title
Satisfaction with pain management
Description
This will be measured using the 6-point Likert scale (very dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, very satisfied)
Time Frame
7 days
Title
Participant Perception of Pain
Description
This will be measured using a 5-point Likert scale (never, almost never, often, almost always, always)
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients over the age of 18 undergoing outpatient primary 1st MTPJ fusion by a fellowship-trained foot and ankle orthopaedic surgeon at the Rothman Orthopaedic Institute Exclusion Criteria: Patients undergoing revision 1st MTPJ fusion; Patients with any allergies to any study medication; Patients with documented chronic narcotic use; Patients with renal insufficiency, as defined by history and preoperative creatinine level (Cr ≥ 2.1 mg/dl); Patients who are pregnant; Patients undergoing inpatient procedure.
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

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Effect of Postoperative Ketorolac on Bone Healing After Joint Fusion

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