Opioid-free Total Hip Arthroplasty

Ketamine

Brief Summary

The primary objective of investigators' proposed study is to demonstrate that the following two cohorts undergoing total hip arthroplasty will have equivalent visual analog scale (VAS) scores up to 3 months post-operatively: one that is administered a modified multimodal analgesic pathway without opioids and the other administered the current standard multimodal analgesic pathway used at Johns Hopkins Bayview Hospital (which includes opioids). The secondary objective is to demonstrate that these cohorts will also have equivalent functional outcomes as determined by both objective measures (such as hip range of motion) and patient-reported outcome measures, such as the Hip Disability and Osteoarthritis Outcome Score (HOOS) and the University of California at Los Angeles (UCLA) activity score.

Intervention / Treatment

Randomized controlled trial
  • Exclusion of opioid analgesics (OTHER)
    The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.

Condition or Disease

  • Hip Osteoarthritis

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Withdrawn
    Study results: No Results Available
    Age: Child, Adult, Older Adult
    Enrollment: 0 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    SINGLE:
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Sep 15, 2022 ESTIMATED
    Primary Completion: Sep 01, 2023 ESTIMATED
    Completion Date: Dec 01, 2023 ESTIMATED
    Study First Posted: Jun 09, 2020 ACTUAL
    Results First Posted: Aug 31, 2020
    Last Updated: Sep 19, 2022

    Sponsors / Collaborators

    Lead Sponsor: Johns Hopkins University
    Lead sponsor is responsible party
    Responsible Party: N/A

    Participant Groups

    • This is the control group, who will receive the current standard multimodal analgesic regimen, which includes opioids following total hip arthroplasty at Johns Hopkins Bayview Hospital. The current standard multimodal analgesic regimen utilizes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Opioid (fentanyl) \& Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: 0.25 % bupivacaine with epinephrine and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Oxycodone 5-10 mg PO, IV opioids (Morphine, hydromorphone), Acetaminophen 1000 mg PO q6hr

    • This is the experimental group, who will receive a modified multimodal analgesic regimen, which excludes the use of any opioids. The modified multimodal analgesic regimen utilizes the following medications: includes the following medications: Gabapentin 300 mg, Celecoxib 200 mg (Meloxicam if sulfa), Non-opioid anesthetics (fluranes, propofol, ketamine, etc.); Periarticular injection: Liposomal bupivacaine, 0.25 % bupivacaine with epinephrine, Betamethasone sodium phosphate, betamethasone acetate and Ketorolac IV; high volume cryotherapy, Ketorolac 30 mg IV, Ketamine IV, Ketorolac 15 mg PO, Acetaminophen 1000 mg PO q6hr

    Eligibility Criteria

    Sex: All
    Age Groups: Child / Adult / Older Adult
    Healthy Volunteers: Yes

    Inclusion Criteria:

    * Patients of all ages with end-stage primary hip osteoarthritis.

    Exclusion Criteria:

    * Patients with creatinine clearance between 30 and 60 mL/min
    * Use of any opioid analgesics in the 6 months preceding surgery
    * Revision total hip arthroplasty
    * Patients with liver insufficiency
    * Patients on chronic anticoagulation
    * Workers compensation patients
    * Patients who cannot receive Acetaminophen, Ketorolac, Celecoxib, or Gabapentin for any reason (e.g. allergies)

    Primary Outcomes

    • Post-operative pain scores ranging from 0 to 10; 0 being no pain and 10 being the worst pain ever felt

    Secondary Outcomes

    • A patient-reported measure that assesses components such as assesses patient pain, satisfaction including stiffness and range of motion, activity limitations-daily living, sports and recreation function, and quality of life. Scores range from 0 to 100 with a score of 0 indicating the worst possible hip symptoms and 100 indicating no hip symptoms.

    • The UCLA scale is a patient-reported measure ranging from 1 to 10. Patients indicate their most appropriate activity level, with 1 defined as "no physical activity, dependent on others" and 10 defined as "regular participation in impact sports."

    More Details

    NCT Number: NCT04421196
    Other IDs: IRB00254474
    Study URL: https://clinicaltrials.gov/study/NCT04421196
    Last updated: Sep 29, 2023